Multiple Attacks Study to Compare the Efficacy and Safety of MK-0974 With Placebo for Acute Migraine (MK-0974-031)

NCT00483704 | Completed Phase 3 Results

• 3 other identifiers: 0974-031MK-0974-0312007_546
• Study Type: interventional
• Target: 1,935
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to assess the safety and efficacy of telcagepant (MK-0974) in acute treatment of multiple migraine attacks with or without aura. Primary hypotheses of this study are that telcagepant is superior to placebo, as measured by the proportion of participants who have pain freedom, pain relief, pain freedom consistency, pain relief consistency, and absence of photophobia, phonophobia, and nausea at 2 hours post-dose.

Conditions

Migraines

Keywords

multiple attacks of moderate to severe migraine headaches

Outcome Measures

Primary Outcomes (9)

• Percentage of Participants Reporting Pain Freedom at 2 Hours Post-dose (First Migraine Attack)

  Pain Freedom (PF) at 2 hours post-dose (first migraine attack), with pain freedom defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 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.

  2 hours post-dose for the first migraine attack (up to 6 months)

• Percentage of Participants Reporting Pain Relief at 2 Hours Post-dose (First Migraine Attack)

  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.

  2 hours post-dose for the first migraine attack (up to 6 months)

• Percentage of Participants Reporting Pain Freedom Consistency at 2 Hours Post-dose

  Pain Freedom Consistency (PFC) at 2 hours post-dose, defined as having achieved PF at 2 hours post-dose on at least 3 treated migraine attacks. Note that for the control groups, a positive PF response arising from the administration of the 1 talcagepant treated migraine attack will count as one of the 3 positive PF responses needed to fulfill the criteria for PFC.

  2 hours post-dose (up to 6 months)

• Percentage of Participants Reporting Pain Relief Consistency at 2 Hours Post-dose

  Pain Relief Consistency (PRC) at 2 hours post-dose, defined as having achieved PR at 2 hours post-dose on at least 3 treated migraine attacks. Note that for the control groups, a positive PR response arising from the administration of the 1 telcagepant treated migraine attack will count as one of the 3 positive PR responses needed to fulfill the criteria for PRC.

  2 hours post-dose (up to 6 months)

• Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-dose (First Migraine Attack)

  The participant recorded whether photophobia (sensitivity to light) was present or absent at each of the predefined time points.

  2 hours post-dose for the first migraine attack (up to 6 months)

• Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-dose (First Migraine Attack)

  The participant recorded whether phonophobia (sensitivity to sound) was present or absent at each of the predefined time points.

  2 hours post-dose for the first migraine attack (up to 6 months)

• Percentage of Participants Reporting Absence of Nausea 2 Hours Post-dose (First Migraine Attack)

  The participant recorded whether nausea was present or absent at each of the predefined time points.

  2 hours post-dose for the first migraine attack (up to 6 months)

• Number of Participants Experiencing an Adverse Event (AE) Within 48 Hours Post-dose (First Migraine Attack)

  AEs were reported following treatment for the first migraine attack using a 48-hour post-dose window. AEs displayed are those reported by at least 4 participants in one or more treatment groups.

  Up to 48 hours post-dose for the first migraine attack (up to 6 months)

• Number of Participants Discontinuing Study Medication Due to an AE

  Participants discontinuing study medication due to an AE were reported for all migraine attacks.

  Up to the 4th dose of study medication (up to 6 months)

Secondary Outcomes (4)

• Percentage of Participants Reporting Sustained Pain Freedom From 2 to 24 Hours Post-dose (First Migraine Attack)

  From 2 to 24 hours post-dose for the first migraine attack (up to 6 months)

• Percentage of Participants Reporting Sustained Pain Freedom From 2 to 48 Hours Post-dose (First Migraine Attack)

  From 2 to 48 hours post-dose for the first migraine attack (up to 6 months)

• Percentage of Participants Reporting Total Migraine Freedom at 2 Hours Post-dose (First Migraine Attack)

  2 hours post-dose for the first migraine attack (up to 6 months)

• Percentage of Participants Reporting Total Migraine Freedom From 2 to 24 Hours Post-dose (First Migraine Attack)

  From 2 to 24 hours post-dose for the first migraine attack (up to 6 months)

Study Arms (4)

Telcagepant 140 mg

EXPERIMENTAL

Telcagepant 140 mg, oral, tablet, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.

Drug: Telcagepant 140 mg

Telcagepant 280 mg

EXPERIMENTAL

Telcagepant 280 mg, oral, tablet, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.

Drug: Talcagepant 280 mg

Control Group 1

PLACEBO COMPARATOR

Placebo, oral, tablet, across 3 migraine attacks (1st, 2nd, and 4th). Telcagepant 140 mg will be administered for the 3rd migraine attack. Participants will receive placebo for the optional second dose. For migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.

Drug: Telcagepant 140 mg; Drug: Placebo

Control Group 2

PLACEBO COMPARATOR

Placebo, oral, tablet, across 3 migraine attacks (1st, 2nd, and 3rd). Telcagepant 140 mg will be administered for the 4th migraine attack. Participants will receive placebo for the optional second dose. For migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.

Drug: Telcagepant 140 mg; Drug: Placebo

Interventions

Telcagepant 140 mg DRUG

Telcagepant 140 mg tablets

Control Group 1; Control Group 2; Telcagepant 140 mg

Talcagepant 280 mg DRUG

Telcagepant 280 mg tablets

Telcagepant 280 mg

Placebo DRUG

Placebo tablets

Control Group 1; Control Group 2

Eligibility Criteria

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

You may qualify if:

• History of migraines within the past year
• to 8 moderate or severe migraine attacks per month in the past 2 months that lasted between 4 to 72 hours if untreated
• Use acceptable contraception throughout the study
• Able to complete the study questionnaire(s) and paper diary
• Limit consumption of grapefruit juice to no more than one 8 ounce glass a day

You may not qualify if:

• Pregnant or breast-feeding or is expecting to become pregnant during the study
• Difficulty distinguishing his/her migraine attacks from tension or interval headaches
• A history of mostly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours
• More than 15 headache-days per month or has taken medication for acute headache on more than 10 days a month in the past 3 months
• Greater than 50 years old at the age of migraine onset
• Previously taken telcagepant

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Ho AP, Dahlof CG, Silberstein SD, Saper JR, Ashina M, Kost JT, Froman S, Leibensperger H, Lines CR, Ho TW. Randomized, controlled trial of telcagepant over four migraine attacks. Cephalalgia. 2010 Dec;30(12):1443-57. doi: 10.1177/0333102410370878. Epub 2010 Jun 8.

  PMID: 20974601 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

telcagepant

Condition Hierarchy (Ancestors)

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

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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2007
• First Posted: June 7, 2007
• Study Start: August 14, 2008
• Primary Completion: March 25, 2009
• Study Completion: March 25, 2009
• Last Updated: October 18, 2018
• Results First Posted: August 29, 2014

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share