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MK0462 5 mg, Sumatriptan 50 mg, and Placebo Comparison Study (0462-029)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00897104
First received: May 8, 2009
Last updated: June 9, 2011
Last verified: June 2011
History of Changes
Results First Received: September 26, 2009  
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 Headache
Interventions: Drug: rizatriptan benzoate (MK0462)
Drug: Comparator: sumatriptan
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
Participants were recruited at 31 sites: 6 in UK, 9 in Norway, 2 in Switzerland, and 14 in Sweden First Participant Treated: August 1995 Last Participant Treated: May 1996.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants screened at a pretreatment visit were given allocated drug supply with instructions. If participants had not treated an attack within 2 months of being enrolled, they were required to return for a rescreen visit. If by 4 months after being enrolled participants still had not treated an attack, they were discontinued from the study.

Reporting Groups
  Description
Rizatriptan 5 mg Rizatriptan 5 mg orally once for treatment of single migraine attack
Sumatriptan 5 mg Sumatriptan 5 mg orally once for treatment of single migraine attack
Placebo Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack

Participant Flow:   Overall Study
    Rizatriptan 5 mg     Sumatriptan 5 mg     Placebo  
STARTED     418 [1]   428 [1]   87 [1]
Participants Treated     355 [2]   357 [2]   80 [2]
Participants Not Treated     63 [3]   71 [3]   7 [3]
COMPLETED     354 [4]   357 [4]   79 [4]
NOT COMPLETED     64     71     8  
Lost to Follow-up                 12                 17                 2  
Pregnancy                 0                 1                 0  
Protocol Violation                 0                 1                 0  
Withdrawal by Subject                 23                 27                 3  
Abnormal Prestudy Labs                 2                 0                 0  
Abnormal Baseline ECG                 2                 2                 0  
Need for Concom. Med.                 0                 1                 1  
Lack of Migraine Attack                 20                 22                 1  
No Longer Met Inc/Exc Criteria                 1                 0                 0  
Not Specified                 3                 0                 0  
Protocol Violation                 1                 0                 0  
Withdrawal by Subject                 0                 0                 1  
[1] Participants who were allocated study drug
[2] Participants who took study drug
[3] Participants who did not take study drug
[4] Participants who took study drug and completed the study



  Baseline Characteristics
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Reporting Groups
  Description
Rizatriptan 5 mg Rizatriptan 5 mg orally once for treatment of single migraine attack
Sumatriptan 5 mg Sumatriptan 5 mg orally once for treatment of single migraine attack
Placebo Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
Total Total of all reporting groups

Baseline Measures
    Rizatriptan 5 mg     Sumatriptan 5 mg     Placebo     Total  
Number of Participants  
[units: participants]
 		  355     357     80     792  
Age  
[units: years]
Mean ± Standard Deviation 		  39.9  ± 10.3     41.8  ± 10.1     44.3  ± 10.5     41.2  ± 10.3  
Gender  
[units: participants]
 		       
Female     291     291     70     652  
Male     64     66     10     140  
Race/Ethnicity, Customized  
[units: participants]
 		       
Caucasian     352     356     80     788  
Asian     3     1     0     4  
Baseline Headache Severity [1]
[units: Participants]
 		       
Grades 0,1: no pain, Mild, or missing     6     8     0     14  
Grade 2: Moderate     216     221     51     488  
Grade 3: Severe     133     128     29     290  
[1] Each participant rated headache severity on a 4-grade scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).



  Outcome Measures
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1.  Primary:   Pain Relief at 2 Hours After Treatment   [ Time Frame: 2 hours after treatment ]
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2.  Primary:   Time to Relief Within 2 Hours After Treatment   [ Time Frame: within 2 hours after treatment ]
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3.  Secondary:   Pain Free at 2 Hours After Treatment   [ Time Frame: 2 hours after treatment ]
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4.  Secondary:   Lack of Functional Disability at 2 Hours After Treatment as Measured by the Level of Impairment in Daily Activities   [ Time Frame: 2 hours after treatment ]
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5.  Secondary:   Presence or Absence of Associated Symptoms (Photophobia, Phonophobia, Nausea, and Vomiting) at 2 Hours After Treatment   [ Time Frame: 2 hours after treatment ]
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6.  Secondary:   Participants Who Used Escape Medication 2 Hours After the Treatment Dose   [ Time Frame: 2 hours after treatment ]
  Show Outcome Measure 6

7.  Secondary:   Duration of Relief (Time to Recurrence From the Time of First Recorded Pain Relief [Grade = 0 or 1])   [ Time Frame: 24 hours ]
  Show Outcome Measure 7


  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
No limitations were encountered in this study.  


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com


Publications:


Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00897104     History of Changes
Other Study ID Numbers: MK-0462-029, 2009_593
Study First Received: May 8, 2009
Results First Received: September 26, 2009
Last Updated: June 9, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency