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Preventive Treatment of Episodic and Chronic Migraine

Primary Purpose

Migraine With Aura, Migraine Without Aura, Chronic Migraine

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
milnacipran
Sponsored by
California Medical Clinic for Headache
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Migraine With Aura

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • California Medical Clinic for Headache

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Reduction in number of migraine days per month in the last month of stable dosing compared to baseline.
Improvement in headache index score
Headache index is defined by headache severity x headache duration.
Reduction in the number of days of headache related disability/impairment
Tolerability
Assessment of adverse events
Use of rescue medications
To assess the continued need for acute headache treatments during the study period.
Quality of life measures

Full Information

First Posted
March 18, 2011
Last Updated
March 18, 2011
Sponsor
California Medical Clinic for Headache
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1. Study Identification

Unique Protocol Identification Number
NCT01319825
Brief Title
Preventive Treatment of Episodic and Chronic Migraine
Official Title
Open Label Study of Milnacipran in the Preventive Treatment of Episodic Migraine With and Without Aura and Chronic Migraine.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
May 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
California Medical Clinic for Headache

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine With Aura, Migraine Without Aura, Chronic Migraine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
milnacipran
Intervention Description
100 mg and 200 mg orally daily for a total of 4 months including a one month titration period.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Reduction in number of migraine days per month in the last month of stable dosing compared to baseline.
Time Frame
4 months
Title
Improvement in headache index score
Description
Headache index is defined by headache severity x headache duration.
Time Frame
4 months
Title
Reduction in the number of days of headache related disability/impairment
Time Frame
4 months
Title
Tolerability
Description
Assessment of adverse events
Time Frame
4 months
Title
Use of rescue medications
Description
To assess the continued need for acute headache treatments during the study period.
Time Frame
4 months
Title
Quality of life measures
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David B Kudrow, MD
Phone
310-315-1456
Email
dbkudrow@earthlink.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David B Kudrow, MD
Organizational Affiliation
California Medical Clinic for Headache
Official's Role
Principal Investigator
Facility Information:
Facility Name
California Medical Clinic for Headache
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatyana Neyman, MD
Phone
310-315-1456
Email
tneyman@drkudrow.com
First Name & Middle Initial & Last Name & Degree
Alan Rapoport, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
24030685
Citation
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.
Results Reference
derived
Links:
URL
http://www.clinicaltrialsla.com
Description
California Medical Clinic for Headache

Learn more about this trial

Preventive Treatment of Episodic and Chronic Migraine

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