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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
Results First Received: October 1, 2014  
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
Condition: Migraine
Interventions: Drug: Telcagepant
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were randomized to telcagepant 140 mg or placebo. Protocol deviation occurred in which 28 participants (called "duplicate participants") were randomized at more than 1 study site (22 unique participants randomized in total 37 times to telcagepant and 12 times to placebo; 6 unique participants randomized in total 12 times to placebo)

Reporting Groups
  Description
Telcagepant 140 mg - Excluding Duplicate Participants Participants who were randomized at only 1 study site and were randomized to 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.
Placebo - Excluding Duplicate Participants Participants who were randomized at only 1 study site and were randomized to 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.
Telcagepant 140 mg - Duplicate Participants Participants who were randomized at more than 1 study site and were randomized at least once to telcagepant and may also have been randomized to placebo. Study drug 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.
Placebo - Duplicate Participants Participants who were randomized at more than 1 study site and each time were randomized to 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.

Participant Flow:   Overall Study
    Telcagepant 140 mg - Excluding Duplicate Participants     Placebo - Excluding Duplicate Participants     Telcagepant 140 mg - Duplicate Participants     Placebo - Duplicate Participants  
STARTED     3018 [1]   1502 [1]   22 [2]   6 [2]
Treated     2638     1322 [3]   21 [4]   5  
COMPLETED     1893     948     13 [5]   3 [6]
NOT COMPLETED     1125     554     9     3  
[1] Randomized
[2] Unique participants randomized
[3] 1 mistakenly took telcagepant and is included with telcagepant group for adverse event analysis
[4] Received telcagepant
[5] Completed study at least once while treated with telcagepant (otherwise counted "Not Completed")
[6] Completed study at least once



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants, including those randomized at more than 1 site ("duplicate participants"). Participants randomized at more than 1 site resulting in randomization into both telcagepant 140 mg and placebo groups are allocated to the telcagepant 140 mg group.

Reporting Groups
  Description
Telcagepant 140 mg 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.
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.
Total Total of all reporting groups

Baseline Measures
    Telcagepant 140 mg     Placebo     Total  
Number of Participants  
[units: participants]
  3040     1508     4548  
Age [1]
[units: Years]
Mean ± Standard Deviation
  36.1  ± 8.6     35.8  ± 8.7     36.0  ± 8.6  
Gender  
[units: Participants]
     
Female     3040     1508     4548  
Male     0     0     0  
[1] Due to missing data, N=3039 and 4547 for Telcagepant 140 mg and Total groups, respectively.



  Outcome Measures
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1.  Primary:   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) ]

2.  Primary:   Number of Participants Who Discontinued Study Due to a Clinical AE   [ Time Frame: Up to 6 months ]

3.  Primary:   Number of Participants With Laboratory AEs   [ Time Frame: Up to 6 months ]

4.  Primary:   Number of Participants Who Discontinued Study Due to a Laboratory AE   [ Time Frame: Up to 6 months ]

5.  Primary:   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 ]

6.  Secondary:   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 ]

7.  Secondary:   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 ]

8.  Secondary:   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 ]

9.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


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