MK0974 (Telcagepant) for Migraine Prophylaxis in Patients With Episodic Migraine (0974-049)

This study has been terminated.
(The study was terminated based on a recommendation of the DSMB following the identification of two patients with significant elevations in serum transaminases)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00797667
First received: November 24, 2008
Last updated: September 4, 2014
Last verified: September 2014
Results First Received: August 13, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Migraine
Interventions: Drug: Telcagepant 140 mg
Drug: Telcagepant 280 mg
Drug: 140 mg telcagepant placebo
Drug: 280 mg telcagepant placebo

  Participant Flow
  Hide Participant Flow

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
No text entered.

Reporting Groups
  Description
Telcagepant 140 mg Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
Telcagepant 280 mg Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
Placebo Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks

Participant Flow:   Overall Study
    Telcagepant 140 mg     Telcagepant 280 mg     Placebo  
STARTED     265     264     131  
Treated     263     263     130  
COMPLETED     5     5     4  
NOT COMPLETED     260     259     127  
Lack of Efficacy                 0                 1                 0  
Lost to Follow-up                 8                 12                 2  
Physician Decision                 3                 1                 0  
Pregnancy                 2                 0                 0  
Protocol Violation                 2                 7                 0  
Study Terminated by Sponsor                 217                 216                 115  
Withdrawal by Subject                 9                 14                 2  
Adverse Event                 19                 8                 8  



  Baseline Characteristics
  Hide Baseline Characteristics

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 enrolled participants who recieved at least one dose of study drug.

Reporting Groups
  Description
Telcagepant 140 mg Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
Telcagepant 280 mg Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
Placebo Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
Total Total of all reporting groups

Baseline Measures
    Telcagepant 140 mg     Telcagepant 280 mg     Placebo     Total  
Number of Participants  
[units: participants]
  263     263     130     656  
Age, Customized  
[units: Participants]
       
< 20 years     2     3     2     7  
20-29 years     54     47     17     118  
30-39 years     52     70     43     165  
40-49 years     81     80     32     193  
50-59 years     66     50     30     146  
60-64 years     7     10     2     19  
>=65 years     1     3     4     8  
Gender  
[units: Participants]
       
Female     223     216     112     551  
Male     40     47     18     105  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Mean Monthly Headache Days   [ Time Frame: Baseline and Week 12 ]

2.  Primary:   Change From Baseline in Mean Monthly Migraine Days   [ Time Frame: Baseline and Week 12 ]

3.  Primary:   Percentage of Participants Who Experienced an Adverse Event   [ Time Frame: up to 14 days after last dose of study drug (up to 12 weeks) ]

4.  Primary:   Percentage of Participants Who Had Study Drug Discontinued During the Study Due to an Adverse Event   [ Time Frame: up to 12 weeks ]

5.  Secondary:   Percentage of Participants With at Least a 50% Reduction in Mean Monthly Headache Days   [ Time Frame: Week 12 ]

6.  Secondary:   Change From Baseline in the Mean Monthly Migraine Attacks   [ Time Frame: Baseline and Week 12 ]

7.  Secondary:   Change From Baseline in the Mean Number of Days Per Month Requiring Rescue Medication   [ Time Frame: Baseline and Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
Based on a recommendation from the external Data Safety Monitoring Board (DSMB), a decision to terminate the trial was made on 26-Mar-2009.


  More Information
  Hide More Information

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: NCT00797667     History of Changes
Other Study ID Numbers: 0974-049, 2008_591
Study First Received: November 24, 2008
Results First Received: August 13, 2014
Last Updated: September 4, 2014
Health Authority: United States: Food and Drug Administration