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MK0462 in Treatment of Migraine With Recurrence (MK0462-022)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00897949
First received: May 8, 2009
Last updated: April 5, 2011
Last verified: April 2011
History of Changes
Results First Received: September 26, 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 Headache
Interventions: Drug: rizatriptan benzoate (MK0462)
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

Patients were recruited at 28 sites in the United States and 18 in 9 other countries.

First Patient Treated: Mar 1995 Last Patient Treated: Jan 1996.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Outpatients randomized at the prestudy visit were given study drug and administration instructions. If patients 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 patients 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
Rizatriptan 10 mg Rizatriptan 10 mg orally once for treatment of single migraine attack
Placebo Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment

Participant Flow:   Overall Study
    Rizatriptan 5 mg     Rizatriptan 10 mg     Placebo  
STARTED     554 [1]   549 [1]   370 [1]
Patients Treated     458 [2]   456 [2]   304 [2]
COMPLETED     450 [3]   446 [3]   301 [3]
NOT COMPLETED     104     103     69  
Adverse Event                 1                 1                 0  
Lost to Follow-up                 0                 2                 1  
Protocol Violation                 6                 3                 1  
Withdrawal by Subject                 1                 2                 0  
Patient Uncoorperative                 0                 2                 1  
Lost to Follow-up                 30                 23                 17  
Withdrawal by Subject                 24                 31                 17  
Abnormal Prestudy Labs                 2                 3                 4  
Abnormal Baseline ECG                 2                 2                 4  
Need for Concom. Med.                 0                 1                 1  
Lack of Migraine Attack                 29                 30                 19  
Did not take study drug                 9                 3                 4  
[1] Patients who were allocated study drug
[2] Patients who took study drug
[3] Patients 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
Rizatriptan 10 mg Rizatriptan 10 mg orally once for treatment of single migraine attack
Placebo Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment
Total Total of all reporting groups

Baseline Measures
    Rizatriptan 5 mg     Rizatriptan 10 mg     Placebo     Total  
Number of Participants  
[units: participants]
 		  458     456     304     1218  
Age  
[units: years]
Mean ± Standard Deviation 		  40.5  ± 9.6     40.7  ± 9.6     40.6  ± 10.5     40.6  ± 9.9  
Gender  
[units: participants]
 		       
Female     394     402     259     1055  
Male     64     54     45     163  
Race/Ethnicity, Customized  
[units: participants]
 		       
Caucasian     430     422     286     1138  
Black     18     7     7     32  
Asian     2     12     3     17  
Hispanic     0     1     1     2  
Mexican-American     0     1     0     1  
Syrian     0     0     1     1  
Anglo-Asian     1     0     0     1  
Mixed     3     4     1     8  
Other     4     9     5     18  
Baseline Headache Severity [1]
[units: Participants]
 		       
Grade 0, 1: No pain, Mild, or missing     8     9     7     24  
Grade 2: Moderate     298     316     202     816  
Grade 3: Severe     152     131     95     378  
[1] Each patient 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 the Initial Dose of Test Drug   [ Time Frame: 2 hours after initial dose of test drug ]

Measure Type Primary
Measure Title Pain Relief at 2 Hours After the Initial Dose of Test Drug
Measure Description Patients reporting pain relief (defined as a reduction of headache severity from grades 2/3 at baseline to 0/1) at 2 hours after the initial dose of test drug. Pain severity was subjectively rated by patients on a scale from grade 0 to 3: Grade 0 - No headache, Grade 1 - Mild pain, Grade 2 - Moderate pain, Grade 3 - Severe pain.
Time Frame 2 hours after initial dose of test drug  
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 primary analysis employed an “all-patients-treated” approach that included all patients who had at least one record of pain severity within 2 hours after the initial dose. Missing data were replaced by carrying forward the preceding value.

Reporting Groups
  Description
Rizatriptan 5 mg Rizatriptan 5 mg orally once for treatment of single migraine attack
Rizatriptan 10 mg Rizatriptan 10 mg orally once for treatment of single migraine attack
Placebo Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment

Measured Values
    Rizatriptan 5 mg     Rizatriptan 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  457     455     302  
Pain Relief at 2 Hours After the Initial Dose of Test Drug  
[units: Participants]
 		     
Reporting pain relief     285     322     106  
Not reporting pain relief     172     133     196  

No statistical analysis provided for Pain Relief at 2 Hours After the Initial Dose of Test Drug



2.  Secondary:   Pain Free at 2 Hours After the Initial Dose of Test Drug   [ Time Frame: 2 hours after initial dose of test drug ]

Measure Type Secondary
Measure Title Pain Free at 2 Hours After the Initial Dose of Test Drug
Measure Description Patients reporting pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after the initial dose of test drug. Pain severity was subjectively rated by patients on a scale from grade 0 to 3: Grade 0 - No headache, Grade 1 - Mild pain, Grade 2 - Moderate pain, Grade 3 - Severe pain.
Time Frame 2 hours after initial dose of test drug  
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.
An “all-patients-treated” approach was employed that included all patients who had at least one record of pain severity within 2 hours after the initial dose. Missing data were replaced by carrying forward the preceding value.

Reporting Groups
  Description
Rizatriptan 5 mg Rizatriptan 5 mg orally once for treatment of single migraine attack
Rizatriptan 10 mg Rizatriptan 10 mg orally once for treatment of single migraine attack
Placebo Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment

Measured Values
    Rizatriptan 5 mg     Rizatriptan 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  457     455     302  
Pain Free at 2 Hours After the Initial Dose of Test Drug  
[units: Participants]
 		     
Reporting no pain     150     193     30  
Reporting pain     307     262     272  

No statistical analysis provided for Pain Free at 2 Hours After the Initial Dose of Test Drug



3.  Secondary:   No Disability at 2 Hours After the Initial Dose of Test Drug   [ Time Frame: 2 hours after initial dose of test drug ]

Measure Type Secondary
Measure Title No Disability at 2 Hours After the Initial Dose of Test Drug
Measure Description Patients with no disability at 2 hours after the initial dose of test drug. Functional disability was subjectively rated on a scale from grade 0 to 3: Grade 0 – Normal, Grade 1 - Daily activities mildly impaired, Grade 2 - Daily activities severely impaired, Grade 3 - Unable to carry out daily activities, requires bedrest
Time Frame 2 hours after initial dose of test drug  
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.
An “all-patients-treated” approach was employed that included all patients who had at least one record of functional disability within 2 hours after the initial dose. Missing data were replaced by carrying forward the preceding value.

Reporting Groups
  Description
Rizatriptan 5 mg Rizatriptan 5 mg orally once for treatment of single migraine attack
Rizatriptan 10 mg Rizatriptan 10 mg orally once for treatment of single migraine attack
Placebo Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment

Measured Values
    Rizatriptan 5 mg     Rizatriptan 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  457     454     300  
No Disability at 2 Hours After the Initial Dose of Test Drug  
[units: Participants]
 		     
Normal     175     209     54  
Mildly Impaired     160     148     118  
Severely Impaired     56     45     53  
Requires Bedrest     66     52     75  

No statistical analysis provided for No Disability at 2 Hours After the Initial Dose of Test Drug



4.  Secondary:   Use of Escape Medication at 2 Hours After the Initial Dose of Test Drug   [ Time Frame: 2 hours after initial dose of test drug ]

Measure Type Secondary
Measure Title Use of Escape Medication at 2 Hours After the Initial Dose of Test Drug
Measure Description No text entered.
Time Frame 2 hours after initial dose of test drug  
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.
An “all-patients-treated” approach was employed that included all patients who had at least one record of pain severity within 2 hours after the initial dose. Missing data were replaced by carrying forward the preceding value.

Reporting Groups
  Description
Rizatriptan 5 mg Rizatriptan 5 mg orally once for treatment of single migraine attack
Rizatriptan 10 mg Rizatriptan 10 mg orally once for treatment of single migraine attack
Placebo Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment

Measured Values
    Rizatriptan 5 mg     Rizatriptan 10 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  458     456     304  
Use of Escape Medication at 2 Hours After the Initial Dose of Test Drug  
[units: Participants]
 		     
Used escape medication     101     76     128  
Did not use escape medication     357     380     176  

No statistical analysis provided for Use of Escape Medication at 2 Hours After the Initial Dose of Test Drug



5.  Secondary:   Pain Relief 2 Hours After Treatment for Headache Recurrence   [ Time Frame: 2 hours after treatment for recurrence ]

Measure Type Secondary
Measure Title Pain Relief 2 Hours After Treatment for Headache Recurrence
Measure Description Patients reporting pain relief 2 hours after treatment for headache recurrence (defined as the return of headache to grade 2 or 3 within 24 hours of the initial dose in patients who reported pain relief (grades 0 or 1) at 2 hours).
Time Frame 2 hours after treatment for recurrence  
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.
Patients with initial headache recurrence who took rizatriptan 5 mg or 10 mg were prerandomized (ratio=1:1) to either rizatriptan 5 mg or 10 mg, respectively, or to placebo (ratio=1:1); and who took placebo, to either 5 mg or 10 mg of rizatriptan (ratio=1:1). Only those who took rizatriptan for their initial headache were considered for analysis.

Reporting Groups
  Description
Rizatriptan 5 mg / Rizatriptan 5 mg Rizatriptan 5 mg initially, prerandomized to rizatriptan 5 mg
Rizatriptan 5 mg / Placebo Rizatriptan 5 mg initially, prerandomized to placebo
Rizatriptan 10 mg / Rizatriptan 10 mg Rizatriptan 10 mg initially, prerandomized to rizatriptan 10 mg
Rizatriptan 10 mg / Placebo Rizatriptan 10 mg initially, prerandomized to placebo
Placebo / Rizatriptan 5 mg Placebo initially, prerandomized to rizatriptan 5 mg
Placebo / Rizatriptan 10 mg Placebo initially, prerandomized to rizatriptan 10 mg

Measured Values
    Rizatriptan 5 mg / Rizatriptan 5 mg     Rizatriptan 5 mg / Placebo     Rizatriptan 10 mg / Rizatriptan 10 mg     Rizatriptan 10 mg / Placebo     Placebo / Rizatriptan 5 mg     Placebo / Rizatriptan 10 mg  
Number of Participants Analyzed  
[units: participants]
 		  55     59     65     75     17     22  
Pain Relief 2 Hours After Treatment for Headache Recurrence  
[units: Participants]
 		           
Pain relief     39     32     53     33     12     18  
No pain relief     16     27     12     42     5     4  

No statistical analysis provided for Pain Relief 2 Hours After Treatment for Headache Recurrence




  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
Pooled Extension data for PN022- NCT00897949; PN025- NCT00899379 and PN029- NCT00897104 appears in NCT01286207  


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


Publications:


Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00897949     History of Changes
Other Study ID Numbers: MK-0462-022, 2009_589
Study First Received: May 8, 2009
Results First Received: September 26, 2009
Last Updated: April 5, 2011
Health Authority: United States: Food and Drug Administration