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Telcagepant (MK-0974) Treatment of Migraine in Participants With Stable Vascular Disease (MK-0974-034)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00662818
First received: April 17, 2008
Last updated: September 15, 2014
Last verified: September 2014
Results First Received: September 5, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Migraine Disorders
Heart Disease
Cerebrovascular Accident
TIA (Transient Ischemic Attack)
Vascular Diseases
Peripheral Vascular Diseases
Interventions: Drug: Telcagepant
Drug: Acetaminophen/Paracetamol
Drug: Placebo to Telcagepant
Drug: Placebo to Acetaminophen/Paracetamol

  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
No text entered.

Reporting Groups
  Description
Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg Participants receive up to 12 doses of telcagepant (300 mg capsule/280 mg tablet), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up to 12 migraine attacks in Period 2 (6 weeks).
Placebo and APAP 1000 mg→Telcagepant 300 mg Participants receive 1 dose of placebo to APAP and placebo to telcagepant for the first migraine attack and then up to 11 doses of APAP and placebo to telcagepant for up to 11 migraine attacks in Period 1 (6 weeks). Participants receive up to 12 doses of telcagepant and placebo to APAP for up to 12 migraine attacks in Period 2 (6 weeks).

Participant Flow for 3 periods

Period 1:   Period 1 (6 Weeks)
    Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg     Placebo and APAP 1000 mg→Telcagepant 300 mg  
STARTED     84     81  
Treated     56     58  
COMPLETED     56     58  
NOT COMPLETED     28     23  

Period 2:   Wash-Out (14 Days)
    Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg     Placebo and APAP 1000 mg→Telcagepant 300 mg  
STARTED     56     58  
COMPLETED     51     53  
NOT COMPLETED     5     5  

Period 3:   Period 2 (6 Weeks)
    Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg     Placebo and APAP 1000 mg→Telcagepant 300 mg  
STARTED     51     53  
COMPLETED     38     41  
NOT COMPLETED     13     12  



  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 treated participants

Reporting Groups
  Description
Telcagepant 300 mg→APAP 1000 mg Participants receive up to 12 doses of telcagepant (280 mg tablet/capsule 300 mg), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up to 12 migraine attacks in Period 2 (6 weeks).
Placebo and APAP 1000 mg→Telcagepant 300 mg Participants receive 1 dose of placebo to APAP and placebo to telcagepant for the first migraine attack and then up to 11 doses of APAP and placebo to telcagepant for up to 11 migraine attacks in Period 1 (6 weeks). Participants receive up to 12 doses of telcagepant and placebo to APAP for up to 12 migraine attacks in Period 2 (6 weeks).
Total Total of all reporting groups

Baseline Measures
    Telcagepant 300 mg→APAP 1000 mg     Placebo and APAP 1000 mg→Telcagepant 300 mg     Total  
Number of Participants  
[units: participants]
  56     58     114  
Age  
[units: Years]
Mean ± Standard Deviation
  56.6  ± 10.1     55.7  ± 10.0     56.1  ± 10.0  
Gender  
[units: Participants]
     
Female     33     36     69  
Male     23     22     45  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Pain Freedom at 2 Hours Post-dose (Period 1, Migraine Attack 1)   [ Time Frame: 2 hours post-dose (Up to 6 weeks) ]

2.  Primary:   Number of Participants Who Experienced an Adverse Event (AE) Within 14 Days Post-dose   [ Time Frame: Within 14 days of any dose of study medication (Up to 16 weeks) ]

3.  Primary:   Number of Participants Discontinuing Study Drug Due to an AE Within 48 Hours Post-dose   [ Time Frame: Up to 48 hours post-dose (Up to 14 weeks) ]

4.  Secondary:   Percentage of Participants With Pain Relief at 2 Hours Post-dose (Period 1, Migraine Attack 1)   [ Time Frame: 2 hours post-dose (Up to 6 weeks) ]

5.  Secondary:   Number of Participants With a Confirmed Vascular Event Within 48 Hours Post-dose   [ Time Frame: Up to 48 hours after the dose of any study medication (Up to 14 weeks) ]

6.  Secondary:   Percentage of Participants With Absence of Phonophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)   [ Time Frame: 2 hours post-dose (Up to 6 weeks) ]

7.  Secondary:   Percentage of Participants With Absence of Photophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)   [ Time Frame: 2 Hours post-dose (Up to 6 weeks) ]

8.  Secondary:   Percentage of Participants With Absence of Nausea at 2 Hours Post-dose (Period 1, Migraine Attack 1)   [ Time Frame: 2 hours post-dose (Up to 6 weeks) ]

9.  Secondary:   Percentage of Participants With Sustained Pain Freedom (SPF) at 2 to 24 Hours Post-dose   [ Time Frame: Up to 24 hours post-dose (Up to 14 weeks) ]


  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
No text entered.


  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 by Merck Sharp & Dohme Corp.

Publications automatically indexed to this study:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00662818     History of Changes
Other Study ID Numbers: 0974-034, MK-0974-034, 2007_545
Study First Received: April 17, 2008
Results First Received: September 5, 2014
Last Updated: September 15, 2014
Health Authority: United States: Food and Drug Administration