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Milnacipran for Migraine Prevention
NCT01319825Phase 4
Key facts
- Status
- Unknown
- Start
- Apr 2011
- Primary completion
- May 2012
- Countries
- 1
- Sponsor
- California Medical Clinic for Headache
- Modality
- Small Molecules
- Drugs
- milnacipran
- Conditions
- migrainechronic migraine
01
Overview
Phase 4, open-label, single-arm trial of milnacipran in migraine and chronic migraine, sponsored by California Medical Clinic for Headache. Primary endpoint: Reduction in number of all headache days per month in the last month of stable dosing compared to baseline at 4 months. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Milnacipran
Milnacipran 100 mg or 200 mg daily
03
Who it enrols
Adult patients with episodic or chronic migraine (at least 2 attacks/month) willing to discontinue current preventives. Excludes patients with medication overuse headache, uncontrolled glaucoma, history of seizures, or failure of 4+ prior preventive trials.
04
Endpoints
Primary
Reduction in number of all headache days per month in the last month of stable dosing compared to baseline
Secondary
Reduction in number of migraine days per month in the last month of stable dosing compared to baseline
Improvement in headache index score
Reduction in the number of days of headache related disability/impairment
Tolerability
Use of rescue medications
Quality of life measures
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