Preventive Treatment of Episodic and Chronic Migraine

Chronic Migraine Clinical Trial

Official title:

Open Label Study of Milnacipran in the Preventive Treatment of Episodic Migraine With and Without Aura and Chronic Migraine.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01319825
• Other study ID #: SAV-MD-26
• Status: Not yet recruiting
• Phase: Phase 4
• First received: March 18, 2011
• Last updated: March 18, 2011
• Start date: April 2011
• Est. completion date: July 2012

Study information

• Verified date: March 2011
• Source: California Medical Clinic for Headache
• Contact: David B Kudrow, MD
• Phone: 310-315-1456
• Email: dbkudrow[@]earthlink.net
• Is FDA regulated: No
• Health authority: United States: Food and Drug Aministration.
• Study type: Interventional

Clinical Trial Summary

This is an open label pilot study to determine whether milnacipran can reduce headache frequency in episodic and chronic migraine sufferers.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: July 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Migraine with or without aura or chronic migraine.

• Subject age 18 to 70.

• At least 2 migraine attacks per month.

• Willing ang able to give written informed consent.

• Willing and able to complete the entire course of the study and to comply with study instructions.

• Willing to taper and discontinue their current preventive medications.

Exclusion Criteria:

• Subject is pregnant, lactating or planning a pregnancy in the next year.

• Subject is female of child-bearing potential and not taking adequate forms of birth control.

• Significant medical or psychiatric disease or abnormal laboratory data that would preclude entry into this study.

• Previous failure of four or more adequate trials of preventive medication.

• Currently on any form of antidepressant for depression and not able to discontinue.

• Currently demonstrating medication overuse headache.

• Currently has uncontrolled narrow angle glaucoma.

• Currently taking monoamine oxidase inhibitors.

• Subject has a history of seizures.

• Participation in an investigational drug study within the last 30 days or 5 half-lives, whichever is longer.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine Disorders
• Migraine with Aura
• Migraine Without Aura

Intervention

Drug:
• milnacipran
100 mg and 200 mg orally daily for a total of 4 months including a one month titration period.

Locations

Country	Name	City	State
United States	California Medical Clinic for Headache	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
California Medical Clinic for Headache

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in number of all headache days per month in the last month of stable dosing, compared to baseline		4 months	No
Secondary	Reduction in number of migraine days per month in the last month of stable dosing compared to baseline.		4 months	No
Secondary	Improvement in headache index score	Headache index is defined by headache severity x headache duration.	4 months	No
Secondary	Reduction in the number of days of headache related disability/impairment		4 months	No
Secondary	Tolerability	Assessment of adverse events	4 months	Yes
Secondary	Use of rescue medications	To assess the continued need for acute headache treatments during the study period.	4 months	No
Secondary	Quality of life measures		4 months	No

External Links

•   California Medical Clinic for Headache