A Study to Test the Safety and Effectiveness of MK-0974 (Telcagepant) Co-administered With Ibuprofen or Acetaminophen in Patients With Migraines With or Without Aura (MK-0974-046)

NCT00758836 | Completed Phase 2 Results

• 3 other identifiers: 0974-0462008_551CTRI/2009/091/000291
• Study Type: interventional
• Target: 683
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will test the safety and how effective telcagepant is when taken with ibuprofen or acetaminophen in participants with migraine with or without aura. The primary study hypothesis is that at least one drug combination is superior to telecagepant alone in the treatment of acute migraines.

Conditions

Migraine

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants With Pain Freedom at Two Hours Post-dose

  Pain severity was rated by the participants in a paper diary by grade; Grade 0 (no pain), Grade 1 (mild pain), Grade 2 (moderate pain), and Grade 3 (severe pain). Pain freedom was defined as a reduction in pain severity from moderate to severe migraine headache (Grade 2 or 3) to no pain (Grade 0).

  2 hours post-dose

• Number of Participants Experiencing Adverse Events Within 48 Hours Post-dose (Count ≥4 in One or More Treatment Groups)

  An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.

  Up to 48 hours post-dose

• Number of Participants Experiencing Adverse Events Within 14 Days Post-dose (Count ≥4 in One or More Treatment Groups)

  An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.

  Up to 14 days post-dose

Secondary Outcomes (1)

• Percentage of Participants With Pain Relief at 2 Hours Post-dose.

  2 hours post-dose

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine

Drug: placebo

Telcagepant 280 mg +Ibuprofen 400 mg

EXPERIMENTAL

Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine

Drug: ibuprofen; Drug: telcagepant

Telcagepant 280 mg +APAP 1000 mg

EXPERIMENTAL

Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine

Drug: acetominophen; Drug: telcagepant

Telcagepant 280 mg

PLACEBO COMPARATOR

Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine

Drug: telcagepant

Interventions

placebo DRUG

Placebo

ibuprofen DRUG

Telcagepant 280 mg +Ibuprofen 400 mg

acetominophen DRUG

Also known as: N-acetyl-p-aminophenol (APAP)

Telcagepant 280 mg +APAP 1000 mg

telcagepant DRUG

Also known as: MK-0974

Telcagepant 280 mg; Telcagepant 280 mg +APAP 1000 mg; Telcagepant 280 mg +Ibuprofen 400 mg

Eligibility Criteria

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

You may qualify if:

• Must be 18 years of age or older
• History of migraine with or without aura for more than 1 year with 1-8 moderate or severe migraine attacks per month in the 2 months prior to starting in the study
• Willing to stay awake for at least 2 hours after taking study drug
• Able to read, understand and complete questionnaires and diaries

You may not qualify if:

• Breast-feeding, pregnant, or plan to become pregnant during the study
• Not able to tell migraine attack from other headaches
• Older than 50 years of age at migraine onset
• Have more than 15 headache days per month or have taken medication for acute headache on more than 10 days per month in any of the 3 months before starting in the study
• History of gastric or small intestinal surgery
• History of heart attack, stroke, unstable angina, coronary artery bypass surgery or transient ischemic attack in the 3 months before starting in the study
• Currently participating or have participated in a study with in investigational compound or device in the last 30 days

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Hewitt DJ, Martin V, Lipton RB, Brandes J, Ceesay P, Gottwald R, Schaefer E, Lines C, Ho TW. Randomized controlled study of telcagepant plus ibuprofen or acetaminophen in migraine. Headache. 2011 Apr;51(4):533-43. doi: 10.1111/j.1526-4610.2011.01860.x.

  PMID: 21457238 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Ibuprofen; Acetaminophen; telcagepant

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; 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

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2008
• First Posted: September 25, 2008
• Study Start: December 3, 2008
• Primary Completion: August 24, 2009
• Study Completion: August 24, 2009
• Last Updated: October 22, 2018
• Results First Posted: August 11, 2014

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share