- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00443209
Telcagepant (MK-0974) Long-Term Safety Study in Adult Participants With Acute Migraine (MK-0974-012)
September 18, 2018 updated by: Merck Sharp & Dohme LLC
A Multicenter, Double-Blind, Active-Controlled, Parallel Group Study to Examine the Safety, Tolerability and Efficacy of Oral MK-0974 for the Long Term Treatment of Acute Migraine With or Without Aura
The purpose of this study is to investigate the safety and tolerability of telcagepant (MK-0974) in the long-term treatment of acute migraine in adult participants.
The primary hypothesis of this study is that telcagepant is well tolerated in the long-term treatment of acute migraine in adult participants.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
1068
Phase
- Phase 3
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:
- At least 1 year history of migraine (with or without aura)
- Females of child bearing potential must use acceptable contraception throughout trial
- In general good health based on screening assessment
Exclusion Criteria:
- Pregnant/breast-feeding (or is a female expecting to conceive during study period)
- History or evidence of stroke/transient ischemic attacks, heart disease, coronary artery vasospasm, other significant underlying cardiovascular diseases, uncontrolled hypertension (high blood pressure), uncontrolled diabetes, or human immunodeficiency virus (HIV) disease
- Major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
- History of gastric, or small intestinal surgery, or has a disease that causes malabsorption
- History of cancer within the last 5 years
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 280 mg/300 mg
Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine.
If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication.
Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
|
One capsule taken orally at onset of migraine
One tablet taken orally at onset of migraine
One tablet taken orally at onset of migraine
|
Active Comparator: Rizatriptan 10 mg
Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine.
If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication.
Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
|
One tablet taken orally at onset of migraine
One capsule taken orally at onset of migraine
One tablet taken orally at onset of migraine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With At Least One Triptan-Related Adverse Experience (AE)
Time Frame: Within 14 days of any dose of study drug (Up to 18.5 months)
|
Triptan-related AEs are defined as: chest pain, chest tightness, asthenia, paraesthesia, dysaesthesia or hyperaesthesia.
Participants were monitored for triptan-related AEs for 14 days after any dose of study drug.
|
Within 14 days of any dose of study drug (Up to 18.5 months)
|
Percentage of Participants With At Least One Clinical AE
Time Frame: Within 14 days of any dose of study drug (Up to 18.5 months)
|
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study 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 is temporally associated with the use of the study product, is also an AE.
A clinical AE was an AE reported as a result of a clinical examination.
Participants were monitored for clinical AEs for 14 days after any dose of study drug.
|
Within 14 days of any dose of study drug (Up to 18.5 months)
|
Percentage of Participants With At Least One Laboratory AE
Time Frame: Within 14 days of any dose of study drug (Up to 18.5 months)
|
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study 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 is temporally associated with the use of the study product, is also an AE.
A laboratory AE was an AE reported as a result of a laboratory assessment or test.
Participants were monitored for laboratory AEs for 14 days after any dose of study drug.
|
Within 14 days of any dose of study drug (Up to 18.5 months)
|
Percentage of Participants With At Least One Vital Sign Measurement Outside Predefined Limits of Change
Time Frame: Within 14 days of any dose of study drug (Up to 18.5 months)
|
Predefined limits of change were established for vital sign measurements: Systolic Blood Pressure (>=180 mm Hg and 20 mm Hg increase OR <=90 mm Hg and 20 mm Hg decrease), Diastolic Blood Pressure (>=105 mm Hg and 15 mm Hg increase OR <=50 mm Hg and 15 mm Hg decrease), Pulse (>=120 beats per minute [bpm] and 15 bpm increase OR <=50 bpm and 15 bpm decrease), Body Temperature (>38º C [oral equivalent]) and Respiratory Rate (>25 or increase of 10 OR <5 or decrease of 10 [per minute]).
Participants were monitored for vital sign measurements outside predefined limits of change for 14 days after any dose of study drug.
|
Within 14 days of any dose of study drug (Up to 18.5 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participant Migraine Attacks With Pain Freedom (PF) at 2 Hours Post-Dose
Time Frame: 2 hours post-dose (Up to 18 months)
|
Participants were asked to rate their migraine headache severity with ratings of 0=No pain, 1=Mild pain, 2=Moderate pain, and 3=Severe pain.
PF at 2 hours post-dose is defined as a decrease from mild, moderate or severe migraine headache (Grade 1, 2, or 3) at baseline to no pain (Grade 0) 2 hours post-dose.
|
2 hours post-dose (Up to 18 months)
|
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)
February 21, 2007
Primary Completion (Actual)
January 22, 2009
Study Completion (Actual)
January 22, 2009
Study Registration Dates
First Submitted
February 28, 2007
First Submitted That Met QC Criteria
March 2, 2007
First Posted (Estimate)
March 5, 2007
Study Record Updates
Last Update Posted (Actual)
October 17, 2018
Last Update Submitted That Met QC Criteria
September 18, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0974-012
- MK-0974-012 (Other Identifier: Merck Protocol Number)
- 2006_524 (Other Identifier: Telerx Study Number)
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 300 mg soft gel capsules
-
Minghui Pharmaceutical (Shanghai) LTDRecruitingRelapsed/Refractory B-cell MalignanciesChina
-
Merck Sharp & Dohme LLCCompleted
-
University Hospital MuensterBasilea Pharmaceutica International LtdTerminatedLupus Erythematosus, CutaneousGermany
-
Reata, a wholly owned subsidiary of BiogenAbbVie; Friedreich's Ataxia Research AllianceActive, not recruitingFriedreich AtaxiaUnited States, Australia, Austria, Italy, United Kingdom
-
Radboud University Medical CenterAstellas Pharma Europe B.V.CompletedMetastatic Castration Resistant Prostate CancerNetherlands
-
Biota Pharmaceuticals, Inc.Completed
-
AIDS Arms Inc.CompletedHIV-1 | AIDSUnited States
-
Hal ChapmanMassachusetts General Hospital; National Heart, Lung, and Blood Institute (NHLBI) and other collaboratorsRecruitingIdiopathic Pulmonary FibrosisUnited States