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

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ClinicalTrials.gov Identifier: NCT00797667
Recruitment Status : Terminated (The study was terminated based on a recommendation of the DSMB following the identification of two patients with significant elevations in serum transaminases)
First Posted : November 25, 2008
Results First Posted : September 8, 2014
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE November 24, 2008
First Posted Date  ICMJE November 25, 2008
Results First Submitted Date  ICMJE August 13, 2014
Results First Posted Date  ICMJE September 8, 2014
Last Update Posted Date October 18, 2018
Actual Study Start Date  ICMJE November 12, 2008
Actual Primary Completion Date May 20, 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2014)
  • Change From Baseline in Mean Monthly Headache Days [ Time Frame: Baseline and Week 12 ]
    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 ]
    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) ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 24, 2008)
Evaluate the efficacy of MK0974 twice daily compared to placebo for prophylactic treatment of migraine and to examine the tolerability and safety of MK0974 twice daily for the prophylactic treatment of migraine. [ Time Frame: 3 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2014)
  • Percentage of Participants With at Least a 50% Reduction in Mean Monthly Headache Days [ Time Frame: Week 12 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MK0974 (Telcagepant) for Migraine Prophylaxis in Patients With Episodic Migraine (0974-049)
Official Title  ICMJE 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
Brief Summary A study to assess the safety and efficacy of MK0974 for preventing migraines in patients with episodic migraine.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE
  • Drug: Telcagepant 140 mg
    Other Name: MK-0974
  • Drug: Telcagepant 280 mg
    Other Name: MK-0974
  • Drug: 140 mg telcagepant placebo
  • Drug: 280 mg telcagepant placebo
Study Arms  ICMJE
  • Experimental: Telcagepant 140 mg
    Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
    Interventions:
    • Drug: Telcagepant 140 mg
    • 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
    Interventions:
    • Drug: Telcagepant 280 mg
    • 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
    Interventions:
    • Drug: 140 mg telcagepant placebo
    • Drug: 280 mg telcagepant placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 4, 2014)
660
Original Estimated Enrollment  ICMJE
 (submitted: November 24, 2008)
600
Actual Study Completion Date  ICMJE May 20, 2009
Actual Primary Completion Date May 20, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00797667
Other Study ID Numbers  ICMJE 0974-049
2008_591
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP