MK0974 (Telcagepant) for Migraine Prophylaxis in Patients With Episodic Migraine (0974-049)

NCT00797667 | Terminated Phase 2 Results DMC

• 2 other identifiers: 0974-0492008_591
• Study Type: interventional
• Target: 660
• Locations: 0 countries
• Sites: N/A

Brief Summary

A study to assess the safety and efficacy of MK0974 for preventing migraines in patients with episodic migraine.

Conditions

Migraine

Outcome Measures

Primary Outcomes (4)

• Change From Baseline in Mean Monthly Headache Days

  Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly headache days; a headache day was defined as any day in which a qualified headache (\>=30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct headache days. Mean monthly rate was adjusted to 28 days.

  Baseline and Week 12

• Change From Baseline in Mean Monthly Migraine Days

  Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly migraine days; a migraine day was defined as any day in which a qualified headache( i.e., aura, photophobia, phonophobia, nausea, or vomiting) started, ended, or recurred. Migraine pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct migraine days. Mean monthly rate was adjusted to 28 days.

  Baseline and Week 12

• Percentage of Participants Who Experienced an Adverse Event

  Participants were assessed throughout the study for adverse events and recorded adverse events in a daily dairy. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event.

  up to 14 days after last dose of study drug (up to 12 weeks)

• Percentage of Participants Who Had Study Drug Discontinued During the Study Due to an Adverse Event

  Participants were assessed throughout the study for adverse events and recorded adverse events in a daily dairy. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event. The percentage of participants who discontinued study was summarized.

  up to 12 weeks

Secondary Outcomes (3)

• Percentage of Participants With at Least a 50% Reduction in Mean Monthly Headache Days

  Week 12

• Change From Baseline in the Mean Monthly Migraine Attacks

  Baseline and Week 12

• Change From Baseline in the Mean Number of Days Per Month Requiring Rescue Medication

  Baseline and Week 12

Study Arms (3)

Telcagepant 140 mg

EXPERIMENTAL

Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks

Drug: Telcagepant 140 mg; Drug: 280 mg telcagepant placebo

Telcagepant 280 mg

EXPERIMENTAL

Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks

Drug: Telcagepant 280 mg; Drug: 140 mg telcagepant placebo

Placebo

PLACEBO COMPARATOR

Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks

Drug: 140 mg telcagepant placebo; Drug: 280 mg telcagepant placebo

Interventions

Telcagepant 140 mg DRUG

Also known as: MK-0974

Telcagepant 140 mg

Telcagepant 280 mg DRUG

Also known as: MK-0974

Telcagepant 280 mg

140 mg telcagepant placebo DRUG

Placebo; Telcagepant 280 mg

280 mg telcagepant placebo DRUG

Placebo; Telcagepant 140 mg

Eligibility Criteria

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

You may qualify if:

• Patient is 18 years of age or older
• Patient has had a history of migraine with or without aura
• Patient is able to complete study questionnaire(s) and paper diary

You may not qualify if:

• Patient is pregnant or breast-feeding, or is a female expecting to conceive within the projected duration of the study
• Patient has basilar or hemiplegic migraine headache, hepatitis or psychiatric conditions
• Patient was older than 50 years of age at migraine onset
• History of gastric or small intestinal surgery or has a disease that causes malabsorption
• Patient has heart attack, unstable angina, coronary artery bypass surgery or other revascularization procedure, stroke, or transient ischemic attack 3 months before starting the study
• Currently participating or has participated in a study with an investigational compound or device within 30 days of starting the study
• Currently participating in a study with MK-0974 or MK-3207

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Ho TW, Connor KM, Zhang Y, Pearlman E, Koppenhaver J, Fan X, Lines C, Edvinsson L, Goadsby PJ, Michelson D. Randomized controlled trial of the CGRP receptor antagonist telcagepant for migraine prevention. Neurology. 2014 Sep 9;83(11):958-66. doi: 10.1212/WNL.0000000000000771. Epub 2014 Aug 8.

  PMID: 25107879 RESULT

MeSH Terms

Conditions

Migraine Disorders

Interventions

telcagepant

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Based on a recommendation from the external Data Safety Monitoring Board (DSMB), a decision to terminate the trial was made on 26-Mar-2009.

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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2008
• First Posted: November 25, 2008
• Study Start: November 12, 2008
• Primary Completion: May 20, 2009
• Study Completion: May 20, 2009
• Last Updated: October 18, 2018
• Results First Posted: September 8, 2014

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share