Study of Telcagepant (MK-0974) in Participants With Moderate to Severe Acute Migraine With or Without Aura (MK-0974-011)

Phase 3

Completed

• Conditions: Migraine
• Interventions: Drug: Telcagepant potassium 150 mg; Drug: Telcagepant potassium 300 mg; Drug: Zolmitriptan 5 mg; Drug: Placebo to tecagepant 300 mg; Drug: Placebo to telcagepant 150 mg; Drug: Placebo to zolmitriptan 5 mg; Drug: Rescue medication

• Registration Number: NCT00442936
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of this study is to investigate the efficacy and safety of telcagepant (MK-0974) compared to an approved medication for acute migraine. This study was conducted as a "triple-dummy" design; for each dose of study drug, participants each received 3 forms of study drug (2 capsules of active and/or placebo and 1 tablet of active and/or placebo) and were instructed to take one of each form of study drug at dosing time.

The primary hypotheses of this study are that telcagepant is superior to placebo in Pain Freedom at 2 Hours Post-Dose, Pain Relief at 2 Hours Post-Dose, Absence of Photophobia at 2 Hours Post-Dose, Absence of Phonophobia at 2 Hours Post-Dose and Absence of Nausea at 2 Hours Post-Dose.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2007-02-15
• Study First Submitted: 2007-02-28
• Study First Submitted QC: 2007-03-02
• Study First Posted: 2007-03-05
• Primary Completion: 2007-10-02
• Study Completion: 2007-10-02
• Results First Submitted: 2014-06-17
• Results First Submitted QC: 2014-07-31
• Results First Posted: 2014-08-04
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-18
• Last Update Posted: 2018-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1380

Inclusion Criteria

• Has at least 1 year history of migraine (with or without aura)
• Females of child bearing potential must use acceptable contraception throughout trial.

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Exclusion Criteria

• Is pregnant/breast-feeding (or is a female expecting to conceive during study period)
• Has 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
• Has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
• Has a history of gastric, or small intestinal surgery, or has a disease that causes malabsorption
• Has a history of cancer within the last 5 years.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telcagepant 150 mg	Telcagepant potassium 150 mg	Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
Telcagepant 150 mg	Placebo to tecagepant 300 mg	Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
Telcagepant 150 mg	Placebo to zolmitriptan 5 mg	Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
Telcagepant 150 mg	Rescue medication	Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
Telcagepant 300 mg	Telcagepant potassium 300 mg	Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
Telcagepant 300 mg	Placebo to telcagepant 150 mg	Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
Telcagepant 300 mg	Placebo to zolmitriptan 5 mg	Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
Telcagepant 300 mg	Rescue medication	Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
Zolmitriptan 5 mg	Placebo to telcagepant 150 mg	Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Zolmitriptan 5 mg	Placebo to tecagepant 300 mg	Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Zolmitriptan 5 mg	Rescue medication	Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Placebo	Placebo to telcagepant 150 mg	Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Placebo	Placebo to tecagepant 300 mg	Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Placebo	Placebo to zolmitriptan 5 mg	Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Placebo	Rescue medication	Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Zolmitriptan 5 mg	Zolmitriptan 5 mg	Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Absence of Photophobia at 2 Hours Post-Dose	2 hours post-dose	Participants were asked if they experienced any sensitivity to light. The number of participants who experienced no photophobia (sensitivity to light) at 2 hours post-dose was determined.
Number of Participants With Absence of Phonophobia at 2 Hours Post-Dose	2 hours post-dose	Participants were asked if they experienced any sensitivity to sound. The number of participants who experienced no phonophobia (sensitivity to sound) at 2 hours post-dose was determined.
Number of Participants With Absence of Nausea at 2 Hours Post-Dose	2 hours post-dose	Participants were asked if they experienced any nausea. The number of participants who experienced no nausea at 2 hours post-dose was determined.
Number of Participants Who Experience At Least One Adverse Event (AE)	Up to 14 days after last dose of study drug	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 drug, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 14 days after last dose study drug. Participants who took both active and placebo study drug were counted in the active group.
Number of Participants Who Discontinue Study Drug Due to an AE	Up to 48 hours after first dose of study drug	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 drug, whether or not considered related to the use of the product. Participants who took both active and placebo study drug were counted in the active group.
Number of Participants With Pain Relief (PR) at 2 Hours Post-Dose	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. PR at 2 hours post-dose is defined as a shift from a moderate or severe migraine headache (Grade 2 or 3) at baseline to mild or no pain (Grade 1 or 0) at 2 hours post-dose.
Number of Participants With Pain Freedom (PF) at 2 Hours Post-Dose	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 a moderate or severe migraine headache (Grade 2 or 3) at baseline to no pain (Grade 0) at 2 hours post-dose.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Sustained Pain Freedom (SPF) From 2 to 24 Hours Post-Dose	2 to 24 hours post-dose	SPF is defined as PF at 2 hours post-dose with no return of mild/moderate/severe headache through 24 hours post-dose, and with no administration of either the optional second dose of study drug or any rescue medication between 2 and 24 hours post-dose.
Number of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose	2 hours post-dose	TMF at 2 hours post-dose is defined as PF at 2 hours post-dose without any of the following migraine-related symptoms: phonophobia, photophobia, nausea or vomiting at 2 hours post-dose.
Number of Participants With Total Migraine Freedom (TMF) at 2 to 24 Hours Post-Dose	2 to 24 hours post-dose	TMF at 2 to 24 hours post-dose is defined as TMF at 2 hours post-dose with no administration of either the optional second dose of study drug or any rescue medication between 2 and 24 hours post-dose, no return of mild/moderate/severe headache within 24 hours and no presence of phonophobia, photophobia, nausea or vomiting within 24 hours post-dose.