Trial Outcomes & Findings for A Study of a Melatonin Receptor Agonist to Prevent Migraine (NCT NCT00739024)

Results Overview

It was planned to use a simple T-Test or ANoVa for data analysis. No Analysis was made due to insufficient recruitment. Planned primary efficacy variable was the percent reduction in the average monthly miqraine/probable migraine frequency from the baseline period to the entire double-blind treatment phase of the study.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

4 weeks

Results posted on

2012-08-23

Participant Flow

8/2008 through March 2010, clinic setting

18 Participants signed Informed Consent. 5 did not qualify for randomization. 13 participants were randomized to Active Treatment or Placebo.

Participant milestones

Participant milestones
Measure	Active Treatment Random assignment to active treatment	Placebo Random assignment to placebo
Overall Study STARTED	7	6
Overall Study COMPLETED	7	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of a Melatonin Receptor Agonist to Prevent Migraine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Treatment n=7 Participants Random assignment to active treatment	Placebo n=6 Participants Random assignment to placebo	Total n=13 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	6 participants n=7 Participants	13 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

It was planned to use a simple T-Test or ANoVa for data analysis. No Analysis was made due to insufficient recruitment. Planned primary efficacy variable was the percent reduction in the average monthly miqraine/probable migraine frequency from the baseline period to the entire double-blind treatment phase of the study.

Outcome measures

Outcome data not reported

Adverse Events

Active Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pat Barrodale, RN

Swedish Headache Center

Phone: 206-215-3502

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place