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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01125774
First received: May 17, 2010
Last updated: October 10, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Migraine
Drug: Telcagepant
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Six Month Phase II/III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of Telcagepant (MK-0974) for Prevention of Menstrually Related Migraine in Female Patients With Episodic Migraine

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants With Clinical Adverse Events (AEs) [ Time Frame: Up to 14 days after the last dose of study drug (Up to 6.5 months) ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants Who Discontinued Study Due to a Clinical AE [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants With Laboratory AEs [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants Who Discontinued Study Due to a Laboratory AE [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
    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.

  • 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 [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    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. MRM participant subgroup (based on symptoms over the 3 menstrual cycles prior to study) - In ≥2 out of 3 cycles attacks occur on Day 1 ± 2 of menstruation and additionally at other times of the cycle.

  • 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 [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly on-drug headache days was calculated from diary data. "On-drug" headache day was a day, which had a valid diary entry and which followed a study drug dosing 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 into additional qualifying days (i.e., day following dosing day) was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 7 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.

  • 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 [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly on-drug headache days was calculated from diary data. "On-drug" headache day was a day, which had a valid diary entry and which followed a study drug dosing 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 into additional qualifying days (i.e., day following dosing day) was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 7 days. MRM participant subgroup (based on symptoms over the 3 menstrual cycles prior to study) - In ≥2 out of 3 cycles attacks occur on Day 1 ± 2 of menstruation additionally at other times of the cycle.

  • 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 [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly on-drug headache days was calculated from diary data. "On-drug" headache day was a day, which had a valid diary entry and which followed a study drug dosing 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 into additional qualifying days (i.e., day following dosing day) was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 7 days. PMM participant subgroups (based on symptoms over the 3 menstrual cycles prior to study) - In ≥2 out of 3 cycles attacks occur exclusively on Day 1 ± 2 of menstruation and at no other times of the cycle.


Enrollment: 4548
Study Start Date: June 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telcagepant
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
Telcagepant 140 mg film coated tablet for oral administration
Other Name: MK-0974
Placebo Comparator: Placebo
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
Placebo to match telcagepant 140 mg film coated tablet for oral administration

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125774

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01125774     History of Changes
Other Study ID Numbers: 0974-065, 2010_535
Study First Received: May 17, 2010
Results First Received: October 1, 2014
Last Updated: October 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Menstrually related migraine
migraine
Premenstrual migraine

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases

ClinicalTrials.gov processed this record on November 25, 2014