Preventive Treatment of Episodic and Chronic Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01319825
Recruitment Status : Unknown
Verified March 2011 by California Medical Clinic for Headache.
Recruitment status was:  Not yet recruiting
First Posted : March 22, 2011
Last Update Posted : March 22, 2011
Information provided by:
California Medical Clinic for Headache

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

Condition or disease Intervention/treatment Phase
Migraine With Aura Migraine Without Aura Chronic Migraine Drug: milnacipran Phase 4

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  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : April 2011
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : July 2012

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

Primary Outcome Measures :
  1. Reduction in number of all headache days per month in the last month of stable dosing, compared to baseline [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Reduction in number of migraine days per month in the last month of stable dosing compared to baseline. [ Time Frame: 4 months ]
  2. Improvement in headache index score [ Time Frame: 4 months ]
    Headache index is defined by headache severity x headache duration.

  3. Reduction in the number of days of headache related disability/impairment [ Time Frame: 4 months ]
  4. Tolerability [ Time Frame: 4 months ]
    Assessment of adverse events

  5. Use of rescue medications [ Time Frame: 4 months ]
    To assess the continued need for acute headache treatments during the study period.

  6. Quality of life measures [ Time Frame: 4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01319825

Contact: David B Kudrow, MD 310-315-1456

United States, California
California Medical Clinic for Headache Not yet recruiting
Santa Monica, California, United States, 90404
Contact: Tatyana Neyman, MD    310-315-1456   
Sub-Investigator: Alan Rapoport, MD         
Sponsors and Collaborators
California Medical Clinic for Headache
Principal Investigator: David B Kudrow, MD California Medical Clinic for Headache

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: David Kudrow, M.D., California Medical Clinic for Headache Identifier: NCT01319825     History of Changes
Other Study ID Numbers: SAV-MD-26
First Posted: March 22, 2011    Key Record Dates
Last Update Posted: March 22, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Migraine Disorders
Migraine with Aura
Migraine without Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents