This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Study to Evaluate the Safety, Tolerability, and Blood Pressure Effect of an Oral Dose of Sumatriptan Alone and in Combination With MK-0974 (Telcagepant) in Migraine Patients (0974-026) (NCT00701389), a randomized phase 1 study. The primary outcome is Time-weighted Mean Arterial Pressure (Sumatriptan With Telcagepant Versus Sumatriptan Alone).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00701389 |
| Phase | Phase 1 |
| Condition | Migraine Disorders |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | Double |
| Enrollment | 24 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Merck Sharp & Dohme LLC |
| Results posted | Yes |
2. Clinical Question
Population
Participants with migraine disorders who had evaluable blood-pressure data for the primary comparison. The registry record reports enrollment of 24 participants. The primary endpoint population is described as participants given sumatriptan with telcagepant or sumatriptan alone in any of the listed treatment periods, regardless of sequence, with evaluable blood-pressure data.
Intervention
A single oral dose of 100 mg sumatriptan together with 600 mg telcagepant. Blood pressure was measured before dosing and at scheduled times after dosing in each treatment period.
Comparator
A single oral dose of 100 mg sumatriptan with telcagepant placebo. The comparison is between the combination and sumatriptan alone, not between two unrelated groups of participants.
Primary question
Whether the combination’s effect on time-weighted mean arterial pressure differs from sumatriptan alone over the postdose interval used for the endpoint. The brief summary states a hypothesis that the true mean treatment difference is less than 5 mmHg.
The crossover design means participants received different treatment conditions in sequence, allowing treatment comparisons to use observations from the same participant. The analysis therefore focuses on the contrast in blood pressure under the combination and sumatriptan-alone conditions, rather than treating all measurements as independent observations. The registry record identifies four treatment conditions, including placebo combinations, and lists randomized treatment sequences. The complete sequence descriptions are not reported in the registry record.
The main result is a sponsor-reported difference in least-squares means of 1.5 mmHg, with a 90% confidence interval from 0.0 to 3.0 mmHg. The registry record describes a threshold of 5 mmHg in its primary hypothesis, but does not report the full protocol or the complete decision rule. The result is therefore best read as an estimated treatment contrast with a stated interval, in the context of that threshold—not as a conclusion about clinical benefit or an individual participant’s blood pressure response.
3. Trial Design
This was a Phase 1 randomized, double-blind, placebo-controlled crossover study in participants with migraine disorders. The registry record gives an enrollment of 24 and a completed status. The study start is recorded as 2007-11-20, and primary completion as 2008-04-10. Merck Sharp & Dohme LLC is listed as the sponsor.
The treatments involved sumatriptan, telcagepant, and matching placebos. The primary comparison was 100 mg sumatriptan with 600 mg telcagepant versus 100 mg sumatriptan with telcagepant placebo. The registry record also lists sumatriptan placebo with 600 mg telcagepant and placebo for both components. Because the design is a crossover, participants received treatment conditions in sequence rather than being assigned to only one condition throughout the study.
The title describes a 3-period study, while the registry record’s sequence descriptions refer to periods 1 through 4 and are truncated before all schedule details are complete. The exact full treatment schedule and any washout arrangements are not reported in the registry record. Random allocation and double masking are recorded; further details about the randomization procedure and how masking was maintained are not reported in the registry record.
The primary endpoint was time-weighted mean arterial pressure, assessed from predose through 150 minutes after dosing in each treatment period. The registry record also lists time-weighted mean arterial pressure for telcagepant versus placebo, participants with an adverse event, and participants discontinued from a study period because of an adverse event as secondary outcomes. It reports four outcome measures and two analyses, but does not provide a complete statistical analysis plan or the planned sample-size justification.
The results are based on the available posted registry record. The primary endpoint population is specifically described as participants with evaluable blood-pressure data for the relevant treatments; that population need not be identical to the total enrollment. The record does not report a participant flow narrative or a detailed account of missing measurements and exclusions.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Period 1
| Stage | Sequence 1: A→C→D→B | Sequence 2: B→D→C→A | Sequence 3: C→B→A→D | Sequence 4: D→A→B→C |
|---|---|---|---|---|
| STARTED | 6 | 6 | 6 | 6 |
| COMPLETED | 6 | 6 | 6 | 6 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Period 2
| Stage | Sequence 1: A→C→D→B | Sequence 2: B→D→C→A | Sequence 3: C→B→A→D | Sequence 4: D→A→B→C |
|---|---|---|---|---|
| STARTED | 6 | 6 | 6 | 6 |
| COMPLETED | 6 | 6 | 6 | 6 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Period 3
| Stage | Sequence 1: A→C→D→B | Sequence 2: B→D→C→A | Sequence 3: C→B→A→D | Sequence 4: D→A→B→C |
|---|---|---|---|---|
| STARTED | 6 | 6 | 6 | 6 |
| COMPLETED | 6 | 6 | 6 | 6 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Period 4
| Stage | Sequence 1: A→C→D→B | Sequence 2: B→D→C→A | Sequence 3: C→B→A→D | Sequence 4: D→A→B→C |
|---|---|---|---|---|
| STARTED | 6 | 6 | 6 | 6 |
| COMPLETED | 6 | 6 | 6 | 6 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Participants who were administered sumatriptan with telcagepant or sumatriptan alone in either Periods 1, 2, 3, or 4 regardless of sequence and had evaluable blood pressure data obtained.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | All Enrolled Participants |
|---|---|---|
| Participants analysed | 24 | |
| Age, Continuous | years | 35.0 (21 to 56) |
| Sex: Female, Male: Female | Participants | 17 |
| Sex: Female, Male: Male | Participants | 7 |
6. Primary Endpoint
The registry lists the primary outcome as Time-weighted Mean Arterial Pressure (Sumatriptan With Telcagepant Versus Sumatriptan Alone), measured over Predose up to 150 minutes postdose of each treatment period (up to 10 weeks).
| Element | Registry entry |
|---|---|
| Result type | Least Squares Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | mmHg |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is time-weighted mean arterial pressure (MAP), reported in mmHg, for sumatriptan with telcagepant versus sumatriptan alone. MAP is a summary of systolic and diastolic blood pressure. The registry record describes calculating it as diastolic blood pressure plus 0.33 multiplied by pulse pressure, where pulse pressure is systolic minus diastolic pressure.
Duplicate semi-recumbent blood-pressure readings were scheduled before dosing and at 30, 60, 90, 120, 150, 180, and 360 minutes after dosing in each treatment period. For the primary time-weighted average, only measurements through and including 150 minutes after dosing, including the predose measurement, were used. The time-weighted average was calculated from the area under the MAP-versus-time curve divided by the measurement period, which the registry record identifies as 150 minutes.
Time-weighting uses measurements across the interval rather than relying on a single postdose reading. As a general statistical point, this can represent the average level across a defined period while accounting for the timing of measurements. It does not by itself describe every fluctuation, the maximum reading, or a participant’s response at a particular time point. The endpoint was used to compare the average blood-pressure profile over the specified interval under the two treatment conditions. The registry record does not report additional endpoint validation or a clinical interpretation threshold beyond the 5 mmHg hypothesis in the brief summary.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The sponsor-reported treatment contrast is a difference in least-squares means of 1.5 mmHg for sumatriptan with telcagepant versus sumatriptan alone. Its 90% confidence interval runs from 0.0 to 3.0 mmHg. The point estimate is therefore positive in the stated comparison, and the interval spans values from no difference at its lower endpoint to a difference of 3.0 mmHg at its upper endpoint. The registry record does not report a p-value for this analysis.
The brief summary frames the primary hypothesis as a mean treatment difference below 5 mmHg. The reported interval’s upper endpoint, 3.0 mmHg, is below that stated threshold. This numerical relationship is consistent with the stated hypothesis, but the registry record does not provide the full protocol, analysis plan, or decision criteria needed to establish exactly how the sponsor formally assessed the hypothesis. In particular, it does not report further details of the non-inferiority or equivalence framework, such as the prespecified analysis population or any additional required conditions.
The registry also reports the treatment-specific least-squares mean values: 89.0 mmHg for the combination condition, with a 95% confidence interval from 85.1 to 92.8, and 87.5 mmHg for sumatriptan with telcagepant placebo, with a 95% confidence interval from 83.6 to 91.4. The sample sizes shown for these arm summaries are 24 and 22, respectively. These arm-level intervals are 95% intervals, whereas the model-based contrast is reported with a 90% interval. They represent different quantities and should not be substituted for the interval around the treatment contrast.
Confidence intervals express uncertainty in an estimate under the analysis model: they give a range of values compatible with the data and method at the stated confidence level. They do not indicate the range of individual participants’ blood-pressure readings, and they do not guarantee that the true value lies within the interval. The contrast interval is relatively informative about the estimated average difference under the model, but it does not establish that every participant had a similar response.
These results describe an average blood-pressure endpoint in this study’s evaluable population and specified postdose interval. They do not establish effects at other times, in other populations, or for treatment outcomes not measured by this endpoint. The registry record reports adverse-event counts separately; those counts do not change the interpretation of the mean arterial pressure estimate. No medical conclusion should be drawn from the numerical contrast alone.
9. Statistical Methods Explained
The primary analysis is described as a mixed effect model, with the treatment contrast expressed as a difference in least-squares means. In general, a mixed effect model can account for the structure of repeated measurements and participant-level variation. This is relevant in a crossover study, where one participant contributes observations under more than one treatment condition. The registry record does not report the model’s full specification, including which effects were fixed or random, how sequence or period was handled, or the covariance structure.
What does a least-squares mean represent?
A least-squares mean is a model-based estimate of a treatment mean, adjusted for terms included in the fitted model. It is not necessarily the same as a simple arithmetic average of all recorded values. The registry record reports treatment-specific least-squares means of 89.0 and 87.5 mmHg, and a model-based difference of 1.5 mmHg. The details of the adjustment cannot be reconstructed from the registry record because the complete model specification is not reported.
How should the confidence interval be read?
The reported contrast has a 90% confidence interval from 0.0 to 3.0 mmHg. In general, a confidence interval describes uncertainty in an estimate under the model and its assumptions. A narrower interval indicates greater precision than a wider interval for the same quantity, but precision is not the same as clinical importance. The interval concerns the average treatment contrast, not individual participant readings. The registry record does not report the p-value for this contrast.
The two treatment-specific means are accompanied by 95% confidence intervals: 85.1 to 92.8 for the combination and 83.6 to 91.4 for sumatriptan with telcagepant placebo. Those intervals are not the same as a confidence interval for the between-treatment contrast. The contrast comes from the reported mixed effect model, which uses the study’s crossover data structure. Comparing overlap between the arm-level intervals is not a substitute for interpreting the model-based contrast interval.
Why does the crossover structure matter?
In a crossover study, treatment and period observations are linked within participants. General statistical methods need to account for that dependence; treating all observations as if they came from separate, unrelated participants may misrepresent uncertainty. A mixed effect model is one approach for handling such repeated or clustered observations. The registry record names that model but does not state all the terms, assumptions, or diagnostic checks used. The full randomization and sequence details are also not reported in the registry record.
What does the time-weighted endpoint summarize?
MAP was derived from systolic and diastolic blood pressure using the stated formula. Measurements through 150 minutes after dosing, including the predose measure, were used to calculate the time-weighted average. In general, an area-under-the-curve approach summarizes measurements across time and accounts for when they were taken. The resulting average describes the defined interval; it does not report the complete time course or the response at every scheduled measurement.
Repeated blood-pressure readings were collected at the listed times, but the posted primary result is the time-weighted average rather than separate estimates at each time. The registry record does not report the distribution of the individual measurements, the model’s handling of any missing time points, or sensitivity analyses. These omissions limit independent assessment of the assumptions behind the model-based estimate.
What is the relevance of the 5 mmHg threshold?
The brief summary states that the primary hypothesis concerns a true mean treatment difference below 5 mmHg. In general, a non-inferiority or equivalence assessment compares an estimated contrast and its uncertainty with a prespecified margin. The reported 90% interval has an upper endpoint of 3.0 mmHg, which is below the stated threshold. However, the full statistical plan and the exact criterion applied are not reported in the registry record, so the numerical relationship should not be expanded into a claim about the sponsor’s formal testing procedure beyond the reported analysis.
The registry’s analysis is identified as a non-inferiority or equivalence type, but the record does not report a p-value or explain whether any multiplicity adjustment was used. It also does not provide enough information to verify how the sample-size target was chosen or whether interim analyses were planned. Those details are not reported in the registry record.
Why can over-dispersion matter in other settings?
As a general statistical concept, over-dispersion occurs when outcome variability is greater than a chosen model assumes. It can make standard errors too small if ignored. The primary endpoint is continuous and analyzed with a mixed effect model; the registry record does not report a finding of over-dispersion or a diagnostic assessment. This general issue should therefore not be taken as a reported feature of this study.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| Mixed Effect Model | Difference in Least Squares Means 1.5 | 0.0 to 3.0 | not reported |
The registry record reports the sponsor’s primary analysis as a mixed effect model estimating a 1.5 mmHg difference in least-squares means, with a 90% confidence interval from 0.0 to 3.0 mmHg. No p-value is reported for this comparison. The record also gives treatment-specific least-squares means and 95% confidence intervals, but these are not a replacement for the model-based contrast.
No independently recalculated two-arm comparison is reported for this continuous endpoint. The registry record indicates that values needed for such a comparison were missing or not estimable. Accordingly, there is no unadjusted recalculation to set against the sponsor’s model result. The sponsor’s analysis is the available inferential comparison, and its interpretation depends on the model and assumptions, details of which are not fully reported in the registry record.
The numerical result can be read alongside the brief summary’s 5 mmHg threshold: the reported interval’s upper endpoint is 3.0 mmHg. The record does not provide the full prespecified statistical plan or enough detail to independently verify every element of the formal hypothesis test. Thus, the reported model estimate and interval should be distinguished from a complete reconstruction of the sponsor’s decision process.
11. Multiplicity, Missing Data and Analysis Populations
The registry record lists four outcome measures and two analyses, including the primary mean arterial pressure comparison and secondary outcomes related to telcagepant versus placebo and adverse events. It does not report a multiplicity strategy, such as whether the analyses were treated as a family or whether any adjustment was made for multiple comparisons. Without that information, the confidence interval should be interpreted as reported for its specific comparison, not as evidence that all trial questions were controlled together for false-positive risk.
The primary endpoint population is described as participants who received the two relevant treatments in any listed period and had evaluable blood-pressure data. The arm-level summaries report 24 participants for the combination and 22 for sumatriptan with telcagepant placebo. The reason for the difference in those summary counts is not reported in the registry record. The full analysis population definition, participant flow, and treatment of missing readings are also not reported in the registry record.
In general, missing outcome data can affect an estimate if the availability of measurements is related to treatment or to the outcome. The registry record does not report the amount, timing, or reasons for missing blood-pressure measurements, nor does it describe imputation or sensitivity analyses. It is therefore not possible to assess the consequences of missingness from the posted information alone.
The record does not report the full statistical analysis plan, the sample-size justification, interim analyses, or prespecified sensitivity analyses. It also does not state whether the analysis population was defined before results were examined. Those details are not reported in the registry record. These gaps do not invalidate the listed estimates, but they limit assessment of how completely the posted analysis reflects the original plan.
12. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| 100 mg Sumatriptan/600 mg Telcagepant | 0 | 24 | 0.0% |
| 100 mg Sumatriptan/Telcagepant Placebo | 0 | 24 | 0.0% |
| Sumatriptan Placebo/600 mg Telcagepant | 0 | 24 | 0.0% |
| Sumatriptan Placebo/Telcagepant Placebo | 0 | 24 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| 100 mg Sumatriptan/600 mg Telcagepant | 5 of 24 |
| 100 mg Sumatriptan/Telcagepant Placebo | 7 of 24 |
| Sumatriptan Placebo/600 mg Telcagepant | 5 of 24 |
| Sumatriptan Placebo/Telcagepant Placebo | 7 of 24 |
Most frequent non-serious adverse event terms
| Event term | Organ system | 100 mg Sumatriptan/600 mg Telcagepant | 100 mg Sumatriptan/Telcagepant Placebo | Sumatriptan Placebo/600 mg Telcagepant | Sumatriptan Placebo/Telcagepant Placebo |
|---|---|---|---|---|---|
| Migraine | Nervous system disorders | 3 of 24 | 4 of 24 | 1 of 24 | 5 of 24 |
| Nausea | Gastrointestinal disorders | 1 of 24 | 2 of 24 | 3 of 24 | 1 of 24 |
| Headache | Nervous system disorders | 1 of 24 | 2 of 24 | 1 of 24 | 1 of 24 |
| Vomiting | Gastrointestinal disorders | 0 of 24 | 2 of 24 | 0 of 24 | 1 of 24 |
The registry record lists serious adverse events for each of the four treatment conditions. The reported number of participants with a serious adverse event is 0 in each condition, with 24 participants at risk in each. No serious adverse-event terms are listed. The death counts are not reported in the registry record.
These are participant counts recorded for treatment conditions, not a detailed account of event timing, severity beyond the serious classification, or causality. Because the study used a crossover design, the conditions are not necessarily independent groups of participants. The registry record does not explain whether participants could contribute to more than one treatment-condition count or provide participant-level event details.
The record also reports other, non-serious adverse events in the four conditions: 5 participants for sumatriptan with telcagepant, 7 for sumatriptan with telcagepant placebo, 5 for sumatriptan placebo with telcagepant, and 7 for placebo for both components. Each condition lists 24 participants at risk. The record does not provide event terms for these counts in the information, and the figures should not be interpreted as a comparative safety test. Counts alone do not establish whether treatments differ in risk.
The registry lists participants discontinued from any study period due to an adverse event as a secondary outcome, but a result for that outcome is not reported in the registry record. The posted safety figures are therefore limited and should be read as descriptive reporting, not as a complete evaluation of safety.
13. What the Result Does, and Does Not, Mean
The result describes a model-estimated difference in time-weighted mean arterial pressure between sumatriptan with telcagepant and sumatriptan alone. The estimate is 1.5 mmHg, and the reported 90% confidence interval ranges from 0.0 to 3.0 mmHg. These values summarize the average contrast in the evaluable population over the endpoint’s defined postdose interval.
The brief summary frames the study question using a threshold of 5 mmHg. The upper endpoint of the reported interval is 3.0 mmHg, below that stated threshold. That is a numerical observation about the reported estimate and interval. It is not a substitute for the full protocol-defined decision rule, which is not reported in the registry record, and it does not establish what the result means for every participant.
The findings do not describe blood pressure beyond the specified endpoint interval, responses at each individual measurement time, or effects in populations not represented in the study. They also do not answer questions about outcomes beyond the blood-pressure measure and the adverse-event counts posted in the registry record. The study’s enrollment was 24, but the primary comparison summaries show different numbers of evaluable participants for the two conditions.
The serious adverse-event counts are 0 for each of the four conditions, while the death counts are not reported in the registry record. Such counts are descriptive; they do not demonstrate equivalent safety or rule out events not captured in the record. Nor do the posted data establish a clinical benefit. The study’s stated focus is safety, tolerability, and blood-pressure effect, and the primary statistical result should be understood within that limited scope.
More broadly, statistical estimates are conditional on the design, data collected, analysis model, and assumptions. The registry record does not report enough detail to independently assess all assumptions, missing-data handling, multiplicity, or the complete analysis plan. Those limitations affect how far the estimate can be generalized or used to make claims beyond the particular comparison.
14. Why This Trial Matters Statistically
This trial illustrates why design and analysis need to be read together. In a crossover study, the same participant may contribute measurements under multiple treatment conditions. That structure can support a within-participant comparison, but it also means that the observations are related rather than independent. The registry’s description of a mixed effect model is relevant to that design, even though the full model specification is not reported.
The endpoint also shows how repeated measurements can be reduced to a summary measure. MAP readings were collected at scheduled times, but the primary comparison uses a time-weighted average through 150 minutes after dosing. The estimate therefore answers a defined average-effect question, not every possible question about the blood-pressure profile. Different summaries of the time course could address different estimands; those additional results are not reported in the registry record.
The stated 5 mmHg threshold provides context for interpreting the reported interval. The interval’s upper endpoint is 3.0 mmHg, but the full decision rule and analysis plan are not reported. This is a useful distinction between reading a numerical estimate and independently verifying a formal non-inferiority or equivalence conclusion.
Finally, the registry gives both an overall enrollment figure and smaller treatment-specific evaluable counts for the primary result. That makes the population underlying an estimate important: enrollment alone does not establish how many participants contributed usable data to each comparison. The record’s missing-data and analysis-population details are limited, so careful interpretation should stay close to the reported endpoint, contrast, and interval.
15. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The posted record does not give a complete description of the crossover schedule. Its title refers to a 3-period study, while sequence descriptions refer to periods 1 through 4 and are truncated. The full treatment schedule and any washout details are not reported in the registry record. This limits assessment of period and sequence context.
The primary comparison is based on evaluable blood-pressure data, with 24 participants reported for the combination condition and 22 for sumatriptan with telcagepant placebo. The reason for the difference is not reported in the registry record. The record does not detail missing measurements, exclusions, participant flow, or sensitivity analyses for missing data.
The sponsor’s model is identified as a mixed effect model, but its full specification, assumptions, and diagnostic checks are not reported. There is no reported p-value for the primary contrast. The record also does not report the multiplicity strategy, sample-size justification, interim analyses, or complete statistical analysis plan. These omissions constrain independent review of the analysis and its prespecified interpretation.
The primary endpoint summarizes MAP over a defined interval and does not supply the full time course in the posted result. The adverse-event information is also limited: serious adverse-event counts and other adverse-event counts are reported by condition, but event details are not included in the record presented, and death counts are not reported in the registry record. These limitations mean the estimates should be interpreted as specific, registry-reported summaries rather than as a comprehensive account of all outcomes or treatment effects.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Study to Evaluate the Safety, Tolerability, and Blood Pressure Effect of an Oral Dose of Sumatriptan Alone and in Combination With MK-0974 (Telcagepant) in Migraine Patients (0974-026) — NCT00701389.
- Registry record last updated 2018-10-17; status last verified 2018-09.
- Results first posted 2014-09-08.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
19. Record Summary
NCT00701389 is a completed Phase 1 randomized, double-blind, placebo-controlled crossover study sponsored by Merck Sharp & Dohme LLC. It enrolled 24 participants with migraine disorders. The recorded study start was 2007-11-20, and primary completion was 2008-04-10.
The primary comparison was time-weighted mean arterial pressure after 100 mg sumatriptan with 600 mg telcagepant versus 100 mg sumatriptan with telcagepant placebo. The sponsor-reported mixed effect model estimated a difference in least-squares means of 1.5 mmHg, with a 90% confidence interval from 0.0 to 3.0 mmHg. The brief summary states a primary hypothesis involving a 5 mmHg threshold.
The registry also reports adverse-event counts by treatment condition. Important details—including the full analysis plan, missing-data handling, multiplicity approach, and complete crossover schedule—are not reported in the registry record.