A Study of a Melatonin Receptor Agonist to Prevent Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00739024
Recruitment Status : Terminated (Recruitment slow and administrative reasons)
First Posted : August 21, 2008
Results First Posted : August 23, 2012
Last Update Posted : August 23, 2012
Information provided by (Responsible Party):
Swedish Medical Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions: Migraine
Migraine With Aura
Migraine Without Aura
Interventions: Drug: Ramelteon
Drug: Placebo

  Participant Flow

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
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 

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

Baseline Measures
   Active Treatment   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   6   13 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   7   6   13 
>=65 years   0   0   0 
[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

  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

  More Information

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.

Results Point of Contact:  
Name/Title: Pat Barrodale, RN
Organization: Swedish Headache Center
phone: 206-215-3502

Responsible Party: Swedish Medical Center Identifier: NCT00739024     History of Changes
Other Study ID Numbers: CRC 0690
First Submitted: August 19, 2008
First Posted: August 21, 2008
Results First Submitted: July 22, 2011
Results First Posted: August 23, 2012
Last Update Posted: August 23, 2012