Preventive Treatment of Episodic and Chronic Migraine

NCT ID: NCT01319825

Last Updated: 2011-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Migraine With Aura Migraine Without Aura Chronic Migraine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

milnacipran

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

California Medical Clinic for Headache

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

California Medical Clinic for Headache

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David B Kudrow, MD

Role: PRINCIPAL_INVESTIGATOR

California Medical Clinic for Headache

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

California Medical Clinic for Headache

Santa Monica, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

David B Kudrow, MD

Role: CONTACT

310-315-1456

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Tatyana Neyman, MD

Role: primary

310-315-1456

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 24030685 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.clinicaltrialsla.com

California Medical Clinic for Headache

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SAV-MD-26

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.