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Two Rizatriptan Prescribing Portions for Treatment of Migraine

This study has been completed.
Sponsor:
Collaborator:
Merck
Information provided by:
Clinvest
ClinicalTrials.gov Identifier:
NCT00397254
First received: November 7, 2006
Last updated: June 7, 2010
Last verified: September 2009
History of Changes
Results First Received: March 6, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Migraine
Intervention: Drug: rizatriptan

  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
3-month Baseline Period occurred prior to randomization to Clinical Limit or Formulary Limit groups. 42 subjects discontinued from total enrollment of 197: (2) Adverse Event (AE), (10) Lost to Follow Up (LFU), (11) Withdrew consent, (1) Pregnancy, (16) Failed to meet Inclusion/Exclusion at Visit 4 Randomization, (2) Other

Reporting Groups
  Description
Rizatriptan 27 Tablets - Clinical Limit Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "clinical limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month.
Rizatriptan 9 Tablets - Formulary Limit Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "formulary limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month.

Participant Flow:   Overall Study
    Rizatriptan 27 Tablets - Clinical Limit     Rizatriptan 9 Tablets - Formulary Limit  
STARTED     79     76  
COMPLETED     77     74  
NOT COMPLETED     2     2  
Lost to Follow-up                 2                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Baseline Period - Rizatriptan 9 Tablets Prior to randomization at Visit 2 (to rizatriptan 9 tablets or rizatriptan 27 tablets), all subjects in Baseline were provided with 9 tablets of rizatriptan.

Baseline Measures
    Baseline Period - Rizatriptan 9 Tablets  
Number of Participants  
[units: participants]
 		  197  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     197  
>=65 years     0  
Age  
[units: years]
Mean ( Full Range ) 		  42  
  ( 18 to 61 )  
Gender  
[units: participants]
 		 
Female     173  
Male     24  
Region of Enrollment  
[units: participants]
 		 
United States     197  



  Outcome Measures
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1.  Primary:   Number of Days With Migraine   [ Time Frame: 6 months ]
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2.  Secondary:   Number of Migraine Attacks   [ Time Frame: 6 months ]
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3.  Secondary:   Percentage of Responders   [ Time Frame: 6 months ]
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4.  Secondary:   Average Attack Duration   [ Time Frame: 6 months ]
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5.  Secondary:   Headache Severity of All Attacks   [ Time Frame: 6 months ]
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6.  Secondary:   Percentage of Attacks With Symptom Elimination at 2 Hours   [ Time Frame: 6 months ]
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7.  Secondary:   Percentage of Attacks With Return to Normal Ability to Perform Activities at 2 Hours Post-dose   [ Time Frame: 6 months ]
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8.  Secondary:   Adverse Experiences   [ Time Frame: 6 months ]
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  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
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Results Point of Contact:  
Name/Title: M.E. Beach
Organization: Clinvest
phone: 417-841-3618
e-mail: mbeach@clinvest.com


Publications:

Publications automatically indexed to this study:


Responsible Party: Roger K. Cady, MD, Clinvest
ClinicalTrials.gov Identifier: NCT00397254     History of Changes
Other Study ID Numbers: 078-00
Study First Received: November 7, 2006
Results First Received: March 6, 2009
Last Updated: June 7, 2010
Health Authority: United States: Institutional Review Board