Clinical trial NCT00701389: 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)
Official title: A Double-Blind, Randomized, Placebo-Controlled, 3-Period, Single Dose Crossover Study to Evaluate the Safety, Tolerability, and Blood Pressure Effect of an Oral Dose of Sumatriptan Alone and in Combination With MK0974 in Migraine Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Migraine Disorders
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-06-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Time-weighted Mean Arterial Pressure (Sumatriptan With Telcagepant Versus Sumatriptan Alone)
timeFrame: Predose up to 150 minutes postdose of each treatment period (up to 10 weeks)
Secondary outcomes:
measure: Time-weighted Mean Arterial Pressure (Telcagepant Versus Placebo)
timeFrame: Predose up to 150 minutes postdose of each treatment period (up to 10 weeks)
measure: Number of Participants Who Experienced an Adverse Event During the Study
timeFrame: up to 14 days after last dose of study drug (up to 10 weeks)
measure: Number of Participants Who Were Discontinued From Any Study Period Due to an Adverse Event
timeFrame: up to 10 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Depre M, Macleod C, Palcza J, Behm M, de Lepeleire I, Han T, Panebianco D, Smith W, Blanchard R, Chodakewitz J, Murphy M, de Hoon J. Lack of hemodynamic interaction between CGRP-receptor antagonist telcagepant (MK-0974) and sumatriptan: results from a randomized study in patients with migraine. Cephalalgia. 2013 Dec;33(16):1292-301. doi: 10.1177/0333102413494272. Epub 2013 Jun 24.