Phase 1
Completed N=24
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)
Migraine Disorders
Source: ClinicalTrials.gov NCT00701389 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcomePrimary: Time-weighted Mean Arterial Pressure (Sumatriptan With Telcagepant Versus Sumatriptan Alone) — 89.0; 87.5 mmHg
Summary
Study to understand the effects of migraine treatments on blood pressure in participants with migraine. The primary hypothesis is that the effect on semi-recumbent mean arterial pressure following the coadministration of telcagepant and sumatriptan is similar to that following administration of sumatriptan alone. That is, the true mean treatment difference (sumatriptan with telcagepant sumatriptan alone) in time-weighted mean arterial pressure for 2.5 hours following dosing is less than 5 mmHg.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-weighted Mean Arterial Pressure (Sumatriptan With Telcagepant Versus Sumatriptan Alone) |
89.0; 87.5 | — |
| SECONDARY Time-weighted Mean Arterial Pressure (Telcagepant Versus Placebo) |
84.7; 83.5 | — |
| SECONDARY Number of Participants Who Experienced an Adverse Event During the Study |
9; 12; 8; 10 | — |
| SECONDARY Number of Participants Who Were Discontinued From Any Study Period Due to an Adverse Event |
0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- History of migraine for longer than 6 months.
- Free from migraine 24 hours before each dosing.
- Judged to be in good health.
- Nonsmoker
Exclusion Criteria
- Under age of legal consent.
- Legally or mentally incapacitated or has significant emotional problems.
- Taking any medications from about 2 weeks before the first dose of study medication.
- Has had surgery or donated blood or participated in another investigation study within 4 weeks prior to screening
- Currently a regular user of any illicit drugs or has a history of drug/alcohol abuse within about 2 years
- Consumes more than 6 caffeinated beverages per day
Data sourced from ClinicalTrials.gov (NCT00701389). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.