Preventive Treatment of Episodic and Chronic Migraine

NCT01319825 | Unknown Phase 4

• 1 other identifier: SAV-MD-26
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Migraine With Aura; Migraine Without Aura; Chronic Migraine

Outcome Measures

Primary Outcomes (1)

• Reduction in number of all headache days per month in the last month of stable dosing, compared to baseline

  4 months

Secondary Outcomes (6)

• Reduction in number of migraine days per month in the last month of stable dosing compared to baseline.

  4 months

• Improvement in headache index score

  4 months

• Reduction in the number of days of headache related disability/impairment

  4 months

• Tolerability

  4 months

• Use of rescue medications

  4 months

Interventions

milnacipran DRUG

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• California Medical Clinic for Headache: lead

Study Sites (1)

California Medical Clinic for Headache

Santa Monica, California, 90404, United States

Location

Related Publications (1)

• Engel ER, Kudrow D, Rapoport AM. A prospective, open-label study of milnacipran in the prevention of headache in patients with episodic or chronic migraine. Neurol Sci. 2014 Mar;35(3):429-35. doi: 10.1007/s10072-013-1536-0. Epub 2013 Sep 13.

  PMID: 24030685 DERIVED

Related Links

• California Medical Clinic for Headache

MeSH Terms

Conditions

Migraine with Aura; Migraine without Aura

Interventions

Milnacipran

Condition Hierarchy (Ancestors)

Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• David B Kudrow, MD

  California Medical Clinic for Headache

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David B Kudrow, MD

CONTACT

310-315-1456; dbkudrow@earthlink.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 18, 2011
• First Posted: March 22, 2011
• Study Start: April 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: July 1, 2012
• Last Updated: March 22, 2011

Record last verified: 2011-03

Locations

US (1)