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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:
ClinicalTrials.gov Identifier:
NCT01125774
First Posted: May 18, 2010
Last Update Posted: June 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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) ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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
Actual Study Start Date: June 1, 2010
Study Completion Date: April 8, 2011
Primary Completion Date: April 8, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125774


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

Publications:
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01125774     History of Changes
Other Study ID Numbers: 0974-065
2010_535 ( Other Identifier: Merck Registration Number )
First Submitted: May 17, 2010
First Posted: May 18, 2010
Results First Submitted: October 1, 2014
Results First Posted: October 3, 2014
Last Update Posted: June 20, 2017
Last Verified: May 2017

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

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