Preventive Treatment of Episodic and Chronic Migraine
Recruitment status was Not yet recruiting
This is an open label pilot study to determine whether milnacipran can reduce headache frequency in episodic and chronic migraine sufferers.
Migraine With Aura
Migraine Without Aura
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Open Label Study of Milnacipran in the Preventive Treatment of Episodic Migraine With and Without Aura and Chronic Migraine.|
- Reduction in number of all headache days per month in the last month of stable dosing, compared to baseline [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Reduction in number of migraine days per month in the last month of stable dosing compared to baseline. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Improvement in headache index score [ Time Frame: 4 months ] [ Designated as safety issue: No ]Headache index is defined by headache severity x headache duration.
- Reduction in the number of days of headache related disability/impairment [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Tolerability [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]Assessment of adverse events
- Use of rescue medications [ Time Frame: 4 months ] [ Designated as safety issue: No ]To assess the continued need for acute headache treatments during the study period.
- Quality of life measures [ Time Frame: 4 months ] [ Designated as safety issue: No ]
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||July 2012|
|Estimated Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Patients with episodic migraine with and/or without aura and chronic migraine will be treated with 100 or 200 mg of milnacipran for a total of 4 months including a one month titration phase and a 3 month maintenance phase. Baseline (pre-treatment) and end-of-maintenance phase headache frequencies will be recorded. There is no placebo treatment in this study. In addition to headache frequencies, other parameters being measured include safety and tolerability.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01319825
|Contact: David B Kudrow, MDfirstname.lastname@example.org|
|United States, California|
|California Medical Clinic for Headache||Not yet recruiting|
|Santa Monica, California, United States, 90404|
|Contact: Tatyana Neyman, MD 310-315-1456 email@example.com|
|Sub-Investigator: Alan Rapoport, MD|
|Principal Investigator:||David B Kudrow, MD||California Medical Clinic for Headache|