MK3207 for Treatment of Acute Migraines (3207-005)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00712725
First received: July 8, 2008
Last updated: April 29, 2014
Last verified: April 2014
Results First Received: October 22, 2010  
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: MK3207- 2.5 mg
Drug: MK3207- 5 mg
Drug: MK3207- 10 mg
Drug: MK3207- 20 mg
Drug: MK3207- 50 mg
Drug: MK3207- 100 mg
Drug: Comparator: placebo (unspecified)

  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 from 47 neurological and general research centers worldwide (19 in the United States and 28 internationally). The primary therapy period was between 2-Jul-08 to 16-Jan-09.

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 the same visit.

Reporting Groups
  Description
Placebo Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 2.5 mg MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 5 mg MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 10 mg MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 20 mg MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 50 mg MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 100 mg MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
MK3207 200 mg MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.

Participant Flow:   Overall Study
    Placebo     MK3207 2.5 mg     MK3207 5 mg     MK3207 10 mg     MK3207 20 mg     MK3207 50 mg     MK3207 100 mg     MK3207 200 mg  
STARTED     169     39     57     84     86     84     83     74  
COMPLETED     140 [1]   33 [1]   47 [1]   67 [1]   67 [1]   68 [1]   61 [2]   63 [1]
NOT COMPLETED     29     6     10     17     19     16     22     11  
Adverse Event                 1                 0                 0                 1                 0                 0                 0                 0  
Lost to Follow-up                 3                 2                 1                 1                 2                 2                 3                 1  
Physician Decision                 2                 0                 0                 0                 1                 0                 2                 0  
Pregnancy                 0                 1                 0                 0                 1                 0                 2                 0  
Protocol Violation                 2                 0                 1                 3                 2                 0                 1                 1  
Withdrawal by Subject                 2                 1                 1                 2                 1                 1                 1                 2  
Lack of Qualifying Event                 16                 2                 6                 8                 11                 13                 11                 6  
Protocol Specified Criteria                 3                 0                 1                 2                 1                 0                 2                 1  
[1] The "Not Completed" patients discontinued prior to receiving study medication.
[2] One patient received study drug. The remaining patients discontinued prior to receiving study drug.



  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.
No text entered.

Reporting Groups
  Description
Placebo

Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.

The participants reported in the Baseline Characteristics are randomized participants that received study treatment.

MK3207 2.5 mg

MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.

The participants reported in the Baseline Characteristics are randomized participants that received study treatment.

MK3207 5 mg

MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.

The participants reported in the Baseline Characteristics are randomized participants that received study treatment.

MK3207 10 mg

MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.

The participants reported in the Baseline Characteristics are randomized participants that received study treatment.

MK3207 20 mg

MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.

The participants reported in the Baseline Characteristics are randomized participants that received study treatment.

MK3207 50 mg

MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.

The participants reported in the Baseline Characteristics are randomized participants that received study treatment.

MK3207 100 mg

MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.

The participants reported in the Baseline Characteristics are randomized participants that received study treatment.

MK3207 200 mg

MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.

The participants reported in the Baseline Characteristics are randomized participants that received study treatment.

Total Total of all reporting groups

Baseline Measures
    Placebo     MK3207 2.5 mg     MK3207 5 mg     MK3207 10 mg     MK3207 20 mg     MK3207 50 mg     MK3207 100 mg     MK3207 200 mg     Total  
Number of Participants  
[units: participants]
  140     33     47     67     67     68     62     63     547  
Age  
[units: years]
Mean ± Standard Deviation
  42.1  ± 11.2     43.3  ± 10.5     43.4  ± 11.1     44.1  ± 10.0     44.1  ± 11.3     42.2  ± 10.8     42.2  ± 10.9     40.5  ± 10.7     42.7  ± 10.9  
Gender  
[units: participants]
                 
Female     125     27     40     62     54     62     52     54     476  
Male     15     6     7     5     13     6     10     9     71  
Ethnicity (NIH/OMB)  
[units: participants]
                 
Hispanic or Latino     15     4     4     4     10     13     9     10     69  
Not Hispanic or Latino     125     29     43     63     57     55     53     53     478  
Unknown or Not Reported     0     0     0     0     0     0     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
                 
White     132     32     46     62     63     64     59     59     517  
Black     5     0     1     3     1     2     2     3     17  
Asian     1     1     0     0     1     1     1     1     6  
American Indian or Alaska Native     1     0     0     1     1     0     0     0     3  
Native Hawaiian or Other Pacific Islander     0     0     0     1     0     1     0     0     2  
Multi-Racial     1     0     0     0     1     0     0     0     2  
Study Region  
[units: Participants]
                 
United States     66     14     22     30     39     45     34     20     270  
Ex-United States     74     19     25     37     28     23     28     43     277  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Pain Freedom (PF)   [ Time Frame: 2 hours postdose ]

2.  Secondary:   Pain Relief (PR)   [ Time Frame: 2 hours postdose ]

3.  Secondary:   Absence of Photophobia   [ Time Frame: 2 hours postdose ]

4.  Secondary:   Absence of Phonophobia   [ Time Frame: 2 hours postdose ]

5.  Secondary:   Absence of Nausea   [ Time Frame: 2 hours postdose ]

6.  Secondary:   Sustained Pain Freedom (SPF)   [ Time Frame: 2-24 hours postdose ]


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


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00712725     History of Changes
Other Study ID Numbers: 3207-005, 2008_536
Study First Received: July 8, 2008
Results First Received: October 22, 2010
Last Updated: April 29, 2014
Health Authority: United States: Food and Drug Administration