Preventive Treatment of Episodic and Chronic Migraine

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

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

Study Overview

• Status: Unknown
• Conditions: Chronic Migraine; Migraine Without Aura; Migraine With Aura
• Intervention / Treatment: Drug: milnacipran

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: David B Kudrow, MD; Phone Number: 310-315-1456; Email: dbkudrow@earthlink.net

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • California Medical Clinic for Headache
      • Contact: Tatyana Neyman, MD; Phone Number: 310-315-1456; Email: tneyman@drkudrow.com
      • Sub-Investigator: Alan Rapoport, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction in number of all headache days per month in the last month of stable dosing, compared to baseline	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Headache index is defined by headache severity x headache duration.	4 months
Reduction in the number of days of headache related disability/impairment		4 months
Tolerability	Assessment of adverse events	4 months
Use of rescue medications	To assess the continued need for acute headache treatments during the study period.	4 months
Quality of life measures		4 months

Collaborators and Investigators

• Sponsor: California Medical Clinic for Headache
• Investigators: Principal Investigator: David B Kudrow, MD, California Medical Clinic for Headache

Publications and helpful links

General Publications

• 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.

Helpful Links

• California Medical Clinic for Headache

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Anticipated): May 1, 2012
• Study Completion (Anticipated): July 1, 2012

Study Registration Dates

• First Submitted: March 18, 2011
• First Submitted That Met QC Criteria: March 18, 2011
• First Posted (Estimate): March 22, 2011

Study Record Updates

• Last Update Posted (Estimate): March 22, 2011
• Last Update Submitted That Met QC Criteria: March 18, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Epilepsy; Migraine Disorders; Migraine without Aura; Migraine with Aura; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Milnacipran; Levomilnacipran
• Other Study ID Numbers: SAV-MD-26