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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: January 23, 2015
Last verified: January 2015
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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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
  Hide 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 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: Senior Vice President, Global Clinical Development
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: January 23, 2015
Health Authority: United States: Food and Drug Administration