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)

NCT ID: NCT00701389

Last Updated: 2018-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-20
• Study Completion Date: 2008-04-10

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.

Conditions

Migraine Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sequence 1: A→C→D→B

Participants receive the following: Period 1: single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treatment A); Period 2: single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C); Period 3: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D); Period 4: single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B). Each dosing period is separated by a 5-day washout.

Group Type: EXPERIMENTAL

telcagepant potassium

Intervention Type: DRUG

Single oral dose of 2 x 300 mg capsules.

sumatriptan

Intervention Type: DRUG

single oral dose of 100 mg sumatriptan

sumatriptan placebo

Intervention Type: DRUG

single oral dose

telcagepant potassium placebo

Intervention Type: DRUG

single oral dose of 2 MK-0974 placebo capsules

Sequence 2: B→D→C→A

Participants receive the following: Period 1: single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B); Period 2: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D): Period 3: single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C); Period 4:single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treatment A). Each dosing period is separated by a 5-day washout.

Group Type: EXPERIMENTAL

telcagepant potassium

Intervention Type: DRUG

Single oral dose of 2 x 300 mg capsules.

sumatriptan

Intervention Type: DRUG

single oral dose of 100 mg sumatriptan

sumatriptan placebo

Intervention Type: DRUG

single oral dose

telcagepant potassium placebo

Intervention Type: DRUG

single oral dose of 2 MK-0974 placebo capsules

Sequence 3: C→B→A→D

Participants receive the following: Period 1 :single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C), Period 2: single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B); Period 3: single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treatment A): Period 4: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D). Each dosing period is separated by a 5-day washout.

Group Type: EXPERIMENTAL

telcagepant potassium

Intervention Type: DRUG

Single oral dose of 2 x 300 mg capsules.

sumatriptan

Intervention Type: DRUG

single oral dose of 100 mg sumatriptan

sumatriptan placebo

Intervention Type: DRUG

single oral dose

telcagepant potassium placebo

Intervention Type: DRUG

single oral dose of 2 MK-0974 placebo capsules

Sequence 4: D→A→B→C

Participants receive the following: Period 1: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D), Period 2: single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treament A); Period 3: single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B); Period 4: single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C). Each dosing period is separated by a 5-day washout.

Group Type: EXPERIMENTAL

telcagepant potassium

Intervention Type: DRUG

Single oral dose of 2 x 300 mg capsules.

sumatriptan

Intervention Type: DRUG

single oral dose of 100 mg sumatriptan

sumatriptan placebo

Intervention Type: DRUG

single oral dose

telcagepant potassium placebo

Intervention Type: DRUG

single oral dose of 2 MK-0974 placebo capsules

Interventions

telcagepant potassium

Single oral dose of 2 x 300 mg capsules.

Intervention Type: DRUG

sumatriptan

single oral dose of 100 mg sumatriptan

Intervention Type: DRUG

sumatriptan placebo

single oral dose

Intervention Type: DRUG

telcagepant potassium placebo

single oral dose of 2 MK-0974 placebo capsules

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: RESULT

PMID: 23798725 (View on PubMed)

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

2008_500

Identifier Type: -

Identifier Source: secondary_id

0974-026

Identifier Type: -

Identifier Source: org_study_id