A Study of a Melatonin Receptor Agonist to Prevent Migraine

This study has been terminated.
(Recruitment slow and administrative reasons)
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Swedish Medical Center
ClinicalTrials.gov Identifier:
NCT00739024
First received: August 19, 2008
Last updated: August 22, 2012
Last verified: August 2012
Results First Received: July 22, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Migraine
Migraine With Aura
Migraine Without Aura
Interventions: Drug: Ramelteon
Drug: 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
8/2008 through March 2010, clinic setting

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
18 Participants signed Informed Consent. 5 did not qualify for randomization. 13 participants were randomized to Active Treatment or Placebo.

Reporting Groups
  Description
Active Treatment Random assignment to active treatment
Placebo Random assignment to placebo

Participant Flow:   Overall Study
    Active Treatment     Placebo  
STARTED     7     6  
COMPLETED     7     6  
NOT COMPLETED     0     0  



  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
Active Treatment Random assignment to active treatment
Placebo Random assignment to placebo
Total Total of all reporting groups

Baseline Measures
    Active Treatment     Placebo     Total  
Number of Participants  
[units: participants]
  7     6     13  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     7     6     13  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     6     3     9  
Male     1     3     4  
Region of Enrollment  
[units: participants]
     
United States     7     6     13  



  Outcome Measures

1.  Primary:   T-Test   [ Time Frame: 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


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
Early termination leading to small numbers of subjects analyzed  


Results Point of Contact:  
Name/Title: Pat Barrodale, RN
Organization: Swedish Headache Center
phone: 206-215-3502
e-mail: pat.barrodale@swedish.org


No publications provided


Responsible Party: Swedish Medical Center
ClinicalTrials.gov Identifier: NCT00739024     History of Changes
Other Study ID Numbers: CRC 0690
Study First Received: August 19, 2008
Results First Received: July 22, 2011
Last Updated: August 22, 2012
Health Authority: United States: Institutional Review Board