Telcagepant (MK-0974) Treatment of Migraine in Participants With Stable Vascular Disease (MK-0974-034)

Phase 3

Completed

• Conditions: Migraine Disorders; Cerebrovascular Accident; Peripheral Vascular Diseases; Heart Disease; TIA (Transient Ischemic Attack); Vascular Diseases
• Interventions: Drug: Telcagepant; Drug: Acetaminophen/Paracetamol; Drug: Placebo to Telcagepant; Drug: Placebo to Acetaminophen/Paracetamol

• Registration Number: NCT00662818
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of telcagepant in the treatment of acute migraine in participants with stable vascular disease. Acetaminophen/paracetamol (APAP) will be used as an active comparator in this study. The primary hypothesis of this study is that telcagepant 300 mg is superior to placebo.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-17
• Study First Submitted: 2008-04-17
• Study First Submitted QC: 2008-04-17
• Study First Posted: 2008-04-21
• Primary Completion: 2009-09-02
• Study Completion: 2009-09-02
• Results First Submitted: 2014-09-05
• Results First Submitted QC: 2014-09-15
• Results First Posted: 2014-09-17
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-18
• Last Update Posted: 2018-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

• Stable coronary artery disease for 3 months or more
• 18 years of age or older with a history of migraine with or without aura
• Must use acceptable contraception throughout the study

Exclusion Criteria

• Pregnant, breast-feeding, or planning to become pregnant during this study
• 50 years of age or older when migraines began
• Other pain syndromes that might interfere with study assessments, uncontrolled psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
• History of gastric, or small intestinal surgery, or has a disease that causes malabsorption

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg	Acetaminophen/Paracetamol	Participants receive up to 12 doses of telcagepant (280 mg tablet/capsule 300 mg), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned.
Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg	Placebo to Acetaminophen/Paracetamol	Participants receive up to 12 doses of telcagepant (280 mg tablet/capsule 300 mg), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned.
Placebo and APAP 1000 mg→Telcagepant 300 mg	Acetaminophen/Paracetamol	Participants receive 1 dose of placebo to APAP and placebo to telcagepant for the first migraine attack and then up to 11 doses of APAP and placebo to telcagepant for up to 11 migraine attacks in Period 1 (6 weeks). Participants receive up to 12 doses of telcagepant and placebo to APAP for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned.
Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg	Placebo to Telcagepant	Participants receive up to 12 doses of telcagepant (280 mg tablet/capsule 300 mg), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned.
Placebo and APAP 1000 mg→Telcagepant 300 mg	Placebo to Telcagepant	Participants receive 1 dose of placebo to APAP and placebo to telcagepant for the first migraine attack and then up to 11 doses of APAP and placebo to telcagepant for up to 11 migraine attacks in Period 1 (6 weeks). Participants receive up to 12 doses of telcagepant and placebo to APAP for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned.
Placebo and APAP 1000 mg→Telcagepant 300 mg	Placebo to Acetaminophen/Paracetamol	Participants receive 1 dose of placebo to APAP and placebo to telcagepant for the first migraine attack and then up to 11 doses of APAP and placebo to telcagepant for up to 11 migraine attacks in Period 1 (6 weeks). Participants receive up to 12 doses of telcagepant and placebo to APAP for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned.
Placebo and APAP 1000 mg→Telcagepant 300 mg	Telcagepant	Participants receive 1 dose of placebo to APAP and placebo to telcagepant for the first migraine attack and then up to 11 doses of APAP and placebo to telcagepant for up to 11 migraine attacks in Period 1 (6 weeks). Participants receive up to 12 doses of telcagepant and placebo to APAP for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned.
Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg	Telcagepant	Participants receive up to 12 doses of telcagepant (280 mg tablet/capsule 300 mg), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Pain Freedom at 2 Hours Post-dose (Period 1, Migraine Attack 1)	2 hours post-dose (Up to 6 weeks)	Pain Freedom (PF) at 2 hours post-dose (Period 1, Attack 1) defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at baseline to no pain (Grade 0). Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.
Number of Participants Who Experienced an Adverse Event (AE) Within 14 Days Post-dose	Within 14 days of any dose of study medication (Up to 16 weeks)	An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Number of Participants Discontinuing Study Drug Due to an AE Within 48 Hours Post-dose	Up to 48 hours post-dose (Up to 14 weeks)	An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Pain Relief at 2 Hours Post-dose (Period 1, Migraine Attack 1)	2 hours post-dose (Up to 6 weeks)	Pain Relief (PR) at 2 hours post-dose (first migraine attack), with pain relief defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 at 2 hours post-dose. Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.
Number of Participants With a Confirmed Vascular Event Within 48 Hours Post-dose	Up to 48 hours after the dose of any study medication (Up to 14 weeks)	Confirmed Vascular Event included cardiac events, cerebrovascular events, and peripheral vascular events.
Percentage of Participants With Absence of Phonophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)	2 hours post-dose (Up to 6 weeks)	The participant recorded whether phonophobia (sensitivity to sound) was present or absent at each of the predefined time points.
Percentage of Participants With Absence of Photophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)	2 Hours post-dose (Up to 6 weeks)	The participant recorded whether photophobia (sensitivity to light) was present or absent at each of the predefined time points.
Percentage of Participants With Absence of Nausea at 2 Hours Post-dose (Period 1, Migraine Attack 1)	2 hours post-dose (Up to 6 weeks)	The participant recorded whether nausea was present or absent at each of the predefined time points.
Percentage of Participants With Sustained Pain Freedom (SPF) at 2 to 24 Hours Post-dose	Up to 24 hours post-dose (Up to 14 weeks)	SPF from 2 to 24 hours post-dose is defined as PF at 2 hours, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with the study medication.