- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00797667
MK0974 (Telcagepant) for Migraine Prophylaxis in Patients With Episodic Migraine (0974-049)
September 21, 2018 updated by: Merck Sharp & Dohme LLC
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
660
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Telcagepant 140 mg
Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
|
Other Names:
|
Experimental: Telcagepant 280 mg
Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
|
Other Names:
|
Placebo Comparator: Placebo
Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and Week 12
|
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.
|
Baseline and Week 12
|
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.
|
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
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.
|
up to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Week 12
|
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.
|
Baseline and Week 12
|
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.
|
Baseline and Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 12, 2008
Primary Completion (Actual)
May 20, 2009
Study Completion (Actual)
May 20, 2009
Study Registration Dates
First Submitted
November 24, 2008
First Submitted That Met QC Criteria
November 24, 2008
First Posted (Estimate)
November 25, 2008
Study Record Updates
Last Update Posted (Actual)
October 18, 2018
Last Update Submitted That Met QC Criteria
September 21, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0974-049
- 2008_591
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Migraine
-
Austrian Migraine Registry CollaborationMedical University of Vienna; Medical University Innsbruck; Austrian Headache...RecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With Aura | Episodic MigraineAustria
-
Tonix Pharmaceuticals, Inc.PremierCompletedChronic Migraine | Chronic Migraine, Headache | Chronic Migraine Without Aura | Aura MigraineUnited States
-
Harvard University Faculty of MedicineBrigham and Women's Hospital; Palmer Center for Chiropractic Research (PCCR)CompletedMigraine | Migraine Disorders | Migraine Without Aura | Migraine With Aura | Migraine, ClassicUnited States
-
University of FlorenceAzienda Ospedaliera Città della Salute e della Scienza di Torino; University... and other collaboratorsRecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With AuraItaly
-
CoolTech LLCTerminatedMigraine | Migraine Without Aura | Migraine With Aura | Episodic MigraineUnited States
-
University of FlorenceAzienda Ospedaliera Città della Salute e della Scienza di Torino; University... and other collaboratorsRecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With AuraItaly
-
Notre-Dame Hospital, Montreal, Quebec, CanadaAllerganCompletedChronic Migraine | Migraine Without Aura | Migraine With AuraCanada
-
Glostrup University Hospital, CopenhagenUnknownChronic Migraine | Migraine Without Aura | Migraine With AuraDenmark
-
Fondazione I.R.C.C.S. Istituto Neurologico Carlo...CompletedMigraine With Aura | Migraine in ChildrenItaly
-
The Cleveland ClinicWithdrawnMigraine | Migraine Disorders | Headache Disorders, Primary | Migraine Headache | Migraine Without Aura | Migraine With Aura | Headache, MigraineUnited States
Clinical Trials on Telcagepant 140 mg
-
Merck Sharp & Dohme LLCCompleted
-
Merck Sharp & Dohme LLCCompleted
-
Bausch Health Americas, Inc.Completed
-
Insmed IncorporatedCompletedCystic FibrosisUnited States
-
MedImmune LLCAmgenCompleted
-
Merck Sharp & Dohme LLCCompletedAngina Pectoris | Coronary Heart Disease | Calcitonin Gene-related Peptide Receptor
-
ExelixisActive, not recruitingMedullary Thyroid CancerAustralia, France, Israel, Spain, Russian Federation, Netherlands, Hungary, Korea, Republic of, Croatia, Italy, Canada, Poland, Romania, Sweden
-
Merck Sharp & Dohme LLCCompleted
-
BionovSeppicCompleted
-
Tonix Pharmaceuticals, Inc.Completed