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Study to Test Rizatriptan in the Early Treatment of Acute Migraine

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00516737
First received: August 13, 2007
Last updated: April 20, 2010
Last verified: April 2010
History of Changes
Results First Received: March 12, 2009  
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: Comparator: rizatriptan benzoate
Drug: Comparator: 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
Phase III First Patient In: 03-October-2007 Last Patient Last Visit: 08-April-2008 13 outpatient centers worldwide (10 United States, 3 Germany)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were assessed, using the protocol inclusion and exclusion criteria, at Visit 1, and if eligible were randomized at that same visit.

Reporting Groups
  Description
Rizatriptan 10 mg ODT Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
Placebo Matching placebo; one dose, treatment of a single migraine attack

Participant Flow:   Overall Study
    Rizatriptan 10 mg ODT     Placebo  
STARTED     103     104  
COMPLETED     92     96  
NOT COMPLETED     11     8  
Lost to Follow-up                 2                 0  
Physician Decision                 0                 1  
Withdrawal by Subject                 0                 1  
Lack of Qualifying Event                 9                 6  



  Baseline Characteristics
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Reporting Groups
  Description
Rizatriptan 10 mg ODT Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
Placebo Matching placebo; one dose, treatment of a single migraine attack
Total Total of all reporting groups

Baseline Measures
    Rizatriptan 10 mg ODT     Placebo     Total  
Number of Participants  
[units: participants]
 		  103     104     207  
Age  
[units: years]
Mean ( Full Range ) 		  41  
  ( 19 to 69 )   		  44  
  ( 18 to 66 )   		  42.5  
  ( 18 to 69 )  
Gender  
[units: participants]
 		     
Female     90     96     186  
Male     13     8     21  
Race/Ethnicity, Customized  
[units: participants]
 		     
Black or African American     4     3     7  
White     95     100     195  
Asian     2     1     3  
Multi-Racial     2     0     2  



  Outcome Measures
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1.  Primary:   Number of Participants Who Are Pain Free at 2 Hours Post-Dose   [ Time Frame: 2 hours post-dose ]
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2.  Secondary:   Number of Participants With 24-Hour Sustained Pain Freedom   [ Time Frame: 24 hours post-dose ]
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3.  Secondary:   Number of Participants With no Rescue Use up to 24 Hours Post-Dose   [ Time Frame: 24 hours post-dose ]
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4.  Secondary:   Number of Participants With Absence of Photophobia at 2 Hours Post-dose   [ Time Frame: 2 hours post-dose ]
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5.  Secondary:   Number of Participants With Absence of Phonophobia at 2 Hours Post-dose   [ Time Frame: 2 hours post-dose ]
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6.  Secondary:   Number of Participants With Absence of Nausea at 2 Hours Post-dose   [ Time Frame: 2 hours post-dose ]
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7.  Secondary:   Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose   [ Time Frame: 2 hours post-dose ]
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Measure Type Secondary
Measure Title Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose
Measure Description

Level of functional disability was assessed on a paper diary by the participants.

Level of functional disability was rated as: normal, mildly impaired, severely impaired or unable to do activities, requires bed rest. Absence of functional disability defined as a rating of normal at 2 hours post-dose.
Time Frame 2 hours post-dose  
Safety Issue No  

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.
The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).

Reporting Groups
  Description
Rizatriptan 10 mg ODT Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
Placebo Matching placebo; one dose, treatment of a single migraine attack

Measured Values
    Rizatriptan 10 mg ODT     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  92     96  
Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose  
[units: Participants]
 		  66     42  

No statistical analysis provided for Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose




  Serious Adverse Events
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  Other Adverse Events
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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.


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
In the Adverse Events section, all non-serious adverse experiences reported are post-treatment, up to the time of taking rescue medication or 14 days post-dose, whichever comes first.  


Results Point of Contact:  
Name/Title: Senior Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


Publications:


Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00516737     History of Changes
Other Study ID Numbers: 2007_547, MK0462-081
Study First Received: August 13, 2007
Results First Received: March 12, 2009
Last Updated: April 20, 2010
Health Authority: United States: Food and Drug Administration