Telcagepant for Prevention of Menstrually Related Migraine in Female Participants With Episodic Migraine (MK-0974-065)

NCT01125774 | Completed Phase 2 Results DMC

• 2 other identifiers: 0974-0652010_535
• Study Type: interventional
• Target: 4,548
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multicenter study to test the hypothesis that telcagepant is superior to placebo in preventing perimenstrual migraines as measured by mean monthly headaches during the entire treatment period. This study will also evaluate the safety and tolerability of telcagepant for female migraine participants.

Conditions

Migraine

Keywords

Menstrually related migraine; migraine; Premenstrual migraine

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Clinical Adverse Events (AEs)

  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 study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A clinical AE is an AE reported as a result of a clinical examination or reported by the participant.

  Up to 14 days after the last dose of study drug (Up to 6.5 months)

• Number of Participants Who Discontinued Study Due to a Clinical AE

  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 study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A clinical AE is an AE reported as a result of a clinical examination or reported by the participant.

  Up to 6 months

• Number of Participants With Laboratory AEs

  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 study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A laboratory AE is an AE reported as a result of a laboratory assessment or test.

  Up to 6 months

• Number of Participants Who Discontinued Study Due to a Laboratory AE

  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 study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A laboratory AE is an AE reported as a result of a laboratory assessment or test.

  Up to 6 months

• Mean Monthly Headache Days During Entire Study Period Among Participants With Menstrually-related Migraine (MRM) or Pure Menstrual Migraine (PMM) Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline

  Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly headache days was calculated from diary data. A headache day was defined as a day in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 28 days. Participant subgroups (based on symptoms over the 3 menstrual cycles prior to study): PMM - In ≥2 out of 3 cycles attacks occur exclusively on Day 1 ± 2 of menstruation and at no other times of the cycle; MRM - In ≥2 out of 3 cycles attacks occur on Day 1 ± 2 of menstruation and additionally at other times of the cycle.

  Up to 6 months

Secondary Outcomes (4)

• Mean Monthly Headache Days During Entire Study Period Among Participants With MRM Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline

  Up to 6 months

• Mean Monthly On-drug Headache Days During the Entire Study Period Among Participants With MRM or PMM Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline

  Up to 6 months

• Mean Monthly On-drug Headache Days During the Entire Study Period Among Participants With MRM Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline

  Up to 6 months

• Mean Monthly On-drug Headache Days During the Entire Study Period Among Participants With PMM Who Have an Average of 3 or More Moderate or Severe Migraine Headaches Per Month at Baseline

  Up to 6 months

Study Arms (2)

Telcagepant

EXPERIMENTAL

Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.

Drug: Telcagepant

Placebo

PLACEBO COMPARATOR

Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.

Drug: Placebo

Interventions

Telcagepant DRUG

Telcagepant 140 mg film coated tablet for oral administration

Also known as: MK-0974

Telcagepant

Placebo DRUG

Placebo to match telcagepant 140 mg film coated tablet for oral administration

Placebo

Eligibility Criteria

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

You may qualify if:

• Participant who has had regular menstrual cycles monthly (22 to 32 days) for at least the last 3 cycles
• Participant experiences headache during menstrual period in at least 2 out of last 3 cycles
• Participant has history of migraine for ≥ 3 months and with ≥ 2 migraine attacks per month in the 2 months prior to screening
• Participant agrees to use an effective method of birth control through the duration of the study

You may not qualify if:

• Participant has basilar or hemiplegic migraine headache
• Participant has taken medication for acute headache on more than 15 days per month in the 3 months prior to screening
• Participant is taking prophylactic medication for migraine and daily dose has changed within 4 weeks prior to screening
• Participant has history of significant liver disease
• Participant has had cardiac surgery or symptoms within 3 months of screening
• Participant has confounding pain syndromes, psychiatric conditions, dementia, or major neurological disorders other than migraine
• Participant has history of neoplastic disease ≤ 5 years prior to signing informed consent
• Participant has history of gastric or small intestinal surgery
• Participant consumes 3 or more alcoholic drinks per day

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Ho TW, Ho AP, Ge YJ, Assaid C, Gottwald R, MacGregor EA, Mannix LK, van Oosterhout WP, Koppenhaver J, Lines C, Ferrari MD, Michelson D. Randomized controlled trial of the CGRP receptor antagonist telcagepant for prevention of headache in women with perimenstrual migraine. Cephalalgia. 2016 Feb;36(2):148-61. doi: 10.1177/0333102415584308. Epub 2015 Apr 29.

  PMID: 25926620 RESULT

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 Director

  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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2010
• First Posted: May 18, 2010
• Study Start: June 1, 2010
• Primary Completion: April 8, 2011
• Study Completion: April 8, 2011
• Last Updated: October 23, 2018
• Results First Posted: October 3, 2014

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share