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)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Migraine Disorders

Treatments: Drug: sumatriptan placebo; Drug: telcagepant potassium placebo; Drug: sumatriptan; Drug: telcagepant potassium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00701389

0974-026

2008_500

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 4 patient groups

Sequence 1: A→C→D→B

Experimental group

Description:

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.

Treatment:

Drug: telcagepant potassium placebo

Drug: sumatriptan

Drug: sumatriptan placebo

Drug: telcagepant potassium

Sequence 2: B→D→C→A

Experimental group

Description:

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.

Treatment:

Drug: telcagepant potassium placebo

Drug: sumatriptan

Drug: sumatriptan placebo

Drug: telcagepant potassium

Sequence 3: C→B→A→D

Experimental group

Description:

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.

Treatment:

Drug: telcagepant potassium placebo

Drug: sumatriptan

Drug: sumatriptan placebo

Drug: telcagepant potassium

Sequence 4: D→A→B→C

Experimental group

Description:

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.

Treatment:

Drug: telcagepant potassium placebo

Drug: sumatriptan

Drug: sumatriptan placebo

Drug: telcagepant potassium