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

NCT00662818 | Completed Phase 3 Results DMC

• 3 other identifiers: 0974-034MK-0974-0342007_545
• Study Type: interventional
• Target: 165
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Migraine Disorders; Heart Disease; Cerebrovascular Accident; TIA (Transient Ischemic Attack); Vascular Diseases; Peripheral Vascular Diseases

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants With Pain Freedom at 2 Hours Post-dose (Period 1, Migraine Attack 1)

  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.

  2 hours post-dose (Up to 6 weeks)

• Number of Participants Who Experienced an Adverse Event (AE) Within 14 Days Post-dose

  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.

  Within 14 days of any dose of study medication (Up to 16 weeks)

• Number of Participants Discontinuing Study Drug Due to an AE Within 48 Hours Post-dose

  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.

  Up to 48 hours post-dose (Up to 14 weeks)

Secondary Outcomes (6)

• Percentage of Participants With Pain Relief at 2 Hours Post-dose (Period 1, Migraine Attack 1)

  2 hours post-dose (Up to 6 weeks)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg

EXPERIMENTAL

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.

Drug: Telcagepant; Drug: Acetaminophen/Paracetamol; Drug: Placebo to Telcagepant; Drug: Placebo to Acetaminophen/Paracetamol

Placebo and APAP 1000 mg→Telcagepant 300 mg

EXPERIMENTAL

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.

Drug: Telcagepant; Drug: Acetaminophen/Paracetamol; Drug: Placebo to Telcagepant; Drug: Placebo to Acetaminophen/Paracetamol

Interventions

Telcagepant DRUG

Telcagepant (MK-0974) (300 mg soft gel capsules or 280 mg tablets)

Placebo and APAP 1000 mg→Telcagepant 300 mg; Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg

Acetaminophen/Paracetamol DRUG

Acetaminophen/Paracetamol (500 mg X 2 dosage units)

Placebo and APAP 1000 mg→Telcagepant 300 mg; Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg

Placebo to Telcagepant DRUG

Placebo 300 mg soft gel capsules or placebo 280 mg tablet.

Placebo and APAP 1000 mg→Telcagepant 300 mg; Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg

Placebo to Acetaminophen/Paracetamol DRUG

Placebo to acetaminophen/paracetamol (500 mg X 2 dosage units)

Placebo and APAP 1000 mg→Telcagepant 300 mg; Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant, breast-feeding, or planning to become pregnant during this study
• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Ho TW, Ho AP, Chaitman BR, Johnson C, Mathew NT, Kost J, Fan X, Aurora SK, Brandes JL, Fei K, Beebe L, Lines C, Krucoff MW. Randomized, controlled study of telcagepant in patients with migraine and coronary artery disease. Headache. 2012 Feb;52(2):224-35. doi: 10.1111/j.1526-4610.2011.02052.x. Epub 2012 Jan 6.

  PMID: 22221076 DERIVED

MeSH Terms

Conditions

Migraine Disorders; Heart Diseases; Stroke; Ischemic Attack, Transient; Vascular Diseases; Peripheral Vascular Diseases

Interventions

telcagepant; Acetaminophen

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Ischemia

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2008
• First Posted: April 21, 2008
• Study Start: March 17, 2008
• Primary Completion: September 2, 2009
• Study Completion: September 2, 2009
• Last Updated: October 19, 2018
• Results First Posted: September 17, 2014

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share