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

Purpose

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

Condition	Intervention	Phase
Migraine	Drug: Telcagepant 140 mg Drug: Telcagepant 280 mg Drug: 140 mg telcagepant placebo Drug: 280 mg telcagepant placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Phase IIa, Multicenter, Randomized, Placebo-controlled Clinical Trial to Study the Safety and Efficacy of MK0974 for Migraine Prophylaxis in Patients With Episodic Migraine

Resource links provided by NLM:

MedlinePlus related topics: Headache Migraine

U.S. FDA Resources

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:

Change From Baseline in Mean Monthly Headache Days [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
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.
Change From Baseline in Mean Monthly Migraine Days [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
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.
Percentage of Participants Who Experienced an Adverse Event [ Time Frame: up to 14 days after last dose of study drug (up to 12 weeks) ] [ Designated as safety issue: Yes ]
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.
Percentage of Participants Who Had Study Drug Discontinued During the Study Due to an Adverse Event [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
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.

Secondary Outcome Measures:

Percentage of Participants With at Least a 50% Reduction in Mean Monthly Headache Days [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
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. The percentage of participants who had at least a 50% reduction in mean monthly headache days during the 12 weeks treatment period was summarized
Change From Baseline in the Mean Monthly Migraine Attacks [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
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 was accompanied with associated symptoms.( i.e., aura, photophobia, phonophobia, nausea, or vomiting) started, ended, or recurred. A migraine attack was defined as any migraine headache that occurs within 2 consecutive calendar days. Pain persisting for more than 2 days after its initial onset was considered a new, distinct migraine attack. The number of migraine attacks that occurred per month was calculated. Mean monthly rate was adjusted to 28 days.
Change From Baseline in the Mean Number of Days Per Month Requiring Rescue Medication [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
Participants completed a diary each evening just before going to bed. Information recorded included: date of assessment, administration of study medication, medication to treat breakthrough migraines and other headaches, associated symptoms, duration of headache pain, headache severity, and side effects. Participants use of medication to treat a breakthrough migraine/headache was considered rescue medication. The number of days per month requiring rescue medication was calculated.


Enrollment:	660
Study Start Date:	November 2008
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Telcagepant 140 mg Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks	Drug: Telcagepant 140 mg Other Name: MK-0974 Drug: 280 mg telcagepant placebo
Experimental: Telcagepant 280 mg Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks	Drug: Telcagepant 280 mg Other Name: MK-0974 Drug: 140 mg telcagepant placebo
Placebo Comparator: Placebo 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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797667

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators


Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information

Publications:

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.


Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00797667 History of Changes
Other Study ID Numbers:	0974-049 2008_591
Study First Received:	November 24, 2008
Results First Received:	August 13, 2014
Last Updated:	November 2, 2015
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 29, 2016