Telcagepant (MK-0974) Long-Term Safety Study in Adult Participants With Acute Migraine (MK-0974-012)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Migraine

Intervention / Treatment
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* Drug: Telcagepant 300 mg soft gel capsules
* Drug: Telcagepant 280 mg tablets
* Drug: Rizatriptan 10 mg tablets
* Drug: Placebo to telcagepant capsules
* Drug: Placebo to telcagepant tablets
* Drug: Placebo to rizatriptan tablets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telcagepant 280 mg/300 mg<br>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. | Drug: Telcagepant 300 mg soft gel capsules<br>* One capsule taken orally at onset of migraine<br>Drug: Telcagepant 280 mg tablets<br>* One tablet taken orally at onset of migraine<br>Drug: Placebo to rizatriptan tablets<br>* One tablet taken orally at onset of migraine<br>|
| Active Comparator: Rizatriptan 10 mg<br>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. | Drug: Rizatriptan 10 mg tablets<br>* One tablet taken orally at onset of migraine<br>Drug: Placebo to telcagepant capsules<br>* One capsule taken orally at onset of migraine<br>Drug: Placebo to telcagepant tablets<br>* One tablet taken orally at onset of migraine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With At Least One Triptan-Related Adverse Experience (AE) | 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 | 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 | 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 | 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 | 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) |