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 | Completed Phase 1 Results

• 2 other identifiers: 0974-0262008_500
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Time-weighted Mean Arterial Pressure (Sumatriptan With Telcagepant Versus Sumatriptan Alone)

  In each treatment period (1 through 4), duplicate readings of semi-recumbent blood pressure (BP) were completed using an automated blood pressure machine at predose, 30, 60, 90, 120, 150, 180, and 360 minutes postdose. Mean arterial pressure (MAP) was calculated as follows: MAP = Diastolic Blood Pressure (DBP) + (0.33 \* Pulse Pressure \[PP\]) where PP = Systolic Blood Pressure \[SBP\] minus DBP. Only mean arterial pressure measurements up to and including 150 minutes postdose (including the predose measurement) were used to calculate the time-weighted averages. Time-weighted averages for each participant were obtained by calculating the area under the measurement-time curve of mean arterial pressure divided by the time period over which measurements were made (i.e. 150 minutes).

  Predose up to 150 minutes postdose of each treatment period (up to 10 weeks)

Secondary Outcomes (3)

• Time-weighted Mean Arterial Pressure (Telcagepant Versus Placebo)

  Predose up to 150 minutes postdose of each treatment period (up to 10 weeks)

• Number of Participants Who Experienced an Adverse Event During the Study

  up to 14 days after last dose of study drug (up to 10 weeks)

• Number of Participants Who Were Discontinued From Any Study Period Due to an Adverse Event

  up to 10 weeks

Study Arms (4)

Sequence 1: A→C→D→B

EXPERIMENTAL

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.

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

Sequence 2: B→D→C→A

EXPERIMENTAL

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.

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

Sequence 3: C→B→A→D

EXPERIMENTAL

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.

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

Sequence 4: D→A→B→C

EXPERIMENTAL

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.

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

Interventions

telcagepant potassium DRUG

Single oral dose of 2 x 300 mg capsules.

Sequence 1: A→C→D→B; Sequence 2: B→D→C→A; Sequence 3: C→B→A→D; Sequence 4: D→A→B→C

sumatriptan DRUG

single oral dose of 100 mg sumatriptan

Sequence 1: A→C→D→B; Sequence 2: B→D→C→A; Sequence 3: C→B→A→D; Sequence 4: D→A→B→C

sumatriptan placebo DRUG

single oral dose

Sequence 1: A→C→D→B; Sequence 2: B→D→C→A; Sequence 3: C→B→A→D; Sequence 4: D→A→B→C

telcagepant potassium placebo DRUG

single oral dose of 2 MK-0974 placebo capsules

Sequence 1: A→C→D→B; Sequence 2: B→D→C→A; Sequence 3: C→B→A→D; Sequence 4: D→A→B→C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of migraine for longer than 6 months.
• Free from migraine 24 hours before each dosing.
• Judged to be in good health.
• Nonsmoker

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 23798725 RESULT

MeSH Terms

Conditions

Migraine Disorders

Interventions

Sumatriptan

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2008
• First Posted: June 19, 2008
• Study Start: November 20, 2007
• Primary Completion: April 10, 2008
• Study Completion: April 10, 2008
• Last Updated: October 17, 2018
• Results First Posted: September 8, 2014

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share