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

This study has been terminated.
(The study was terminated based on a recommendation of the DSMB following the identification of two patients with significant elevations in serum transaminases)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00797667
First received: November 24, 2008
Last updated: September 4, 2014
Last verified: September 2014

November 24, 2008
September 4, 2014
November 2008
May 2009   (final data collection date for primary outcome measure)
  • 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.
Evaluate the efficacy of MK-0974 twice daily compared to placebo for prophylactic treatment of migraine and to examine the tolerability and safety of MK-0974 twice daily for the prophylactic treatment of migraine. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00797667 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
MK0974 (Telcagepant) for Migraine Prophylaxis in Patients With Episodic Migraine (0974-049)
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Migraine
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
660
May 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00797667
0974-049, 2008_591
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
September 2014

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