Study of Telcagepant (MK-0974) in Participants With Moderate to Severe Acute Migraine With or Without Aura (MK-0974-011)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00442936
First received: February 28, 2007
Last updated: July 31, 2014
Last verified: July 2014
Results First Received: June 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Migraine
Interventions: Drug: Telcagepant potassium 150 mg
Drug: Telcagepant potassium 300 mg
Drug: Zolmitriptan 5 mg
Drug: Placebo to telcagepant 150 mg
Drug: Placebo to tecagepant 300 mg
Drug: Placebo to zolmitriptan 5 mg
Drug: Rescue medication

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Telcagepant 150 mg Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
Telcagepant 300 mg Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
Zolmitriptan 5 mg Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Placebo Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.

Participant Flow:   Overall Study
    Telcagepant 150 mg     Telcagepant 300 mg     Zolmitriptan 5 mg     Placebo  
STARTED     333     354     345     348  
COMPLETED     332     354     344     347  
NOT COMPLETED     1     0     1     1  
Protocol Violation                 1                 0                 1                 1  



  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.
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Reporting Groups
  Description
Telcagepant 150 mg Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
Telcagepant 300 mg Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
Zolmitriptan 5 mg Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Placebo Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Total Total of all reporting groups

Baseline Measures
    Telcagepant 150 mg     Telcagepant 300 mg     Zolmitriptan 5 mg     Placebo     Total  
Number of Participants  
[units: participants]
  333     354     345     348     1380  
Age  
[units: Years]
Mean ± Standard Deviation
  42.7  ± 11.2     42.6  ± 11.4     41.7  ± 11.7     42.3  ± 11.6     42.3  ± 11.4  
Gender  
[units: Participants]
         
Female     277     300     298     294     1169  
Male     56     54     47     54     211  



  Outcome Measures
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1.  Primary:   Number of Participants With Pain Freedom (PF) at 2 Hours Post-Dose   [ Time Frame: 2 hours post-dose ]

2.  Primary:   Number of Participants With Pain Relief (PR) at 2 Hours Post-Dose   [ Time Frame: 2 hours post-dose ]

3.  Primary:   Number of Participants With Absence of Photophobia at 2 Hours Post-Dose   [ Time Frame: 2 hours post-dose ]

4.  Primary:   Number of Participants With Absence of Phonophobia at 2 Hours Post-Dose   [ Time Frame: 2 hours post-dose ]

5.  Primary:   Number of Participants With Absence of Nausea at 2 Hours Post-Dose   [ Time Frame: 2 hours post-dose ]

6.  Primary:   Number of Participants Who Experience At Least One Adverse Event (AE)   [ Time Frame: Up to 14 days after last dose of study drug ]

7.  Primary:   Number of Participants Who Discontinue Study Drug Due to an AE   [ Time Frame: Up to 48 hours after first dose of study drug ]

8.  Secondary:   Number of Participants With Sustained Pain Freedom (SPF) From 2 to 24 Hours Post-Dose   [ Time Frame: 2 to 24 hours post-dose ]

9.  Secondary:   Number of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose   [ Time Frame: 2 hours post-dose ]

10.  Secondary:   Number of Participants With Total Migraine Freedom (TMF) at 2 to 24 Hours Post-Dose   [ Time Frame: 2 to 24 hours post-dose ]


  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


Publications:
Publications automatically indexed to this study:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00442936     History of Changes
Other Study ID Numbers: 0974-011, MK-0974-011, 2006_525
Study First Received: February 28, 2007
Results First Received: June 17, 2014
Last Updated: July 31, 2014
Health Authority: United States: Food and Drug Administration