A Research Study Examining The Use Of Duloxetine In The Prevention Of Migraine Headache

NCT00443352 | Completed Phase 4 Results DMC

• 1 other identifier: Protocol #: F1J-MC-I
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, open-label, pilot trial to collect and evaluate data on the safety and efficacy of duloxetine in the preventive treatment of subjects experiencing episodic migraine headaches. Following a 28-day baseline period, qualifying subjects will be entered into an 84-day treatment period. Subjects will be titrated over the first four weeks to a dose of 120mg or their maximally tolerated dose (MTD). The dose adjustments will be based on individual subject response and/or subject's tolerability. Subjects will maintain a daily diary capturing detailed information on migraine headache days.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Change in Frequency of Migraine Days During the Last 28 Day Interval of the Treatment Period as Compared to the 28 Day Baseline Period.

  Change in frequency of migraine days from day -28 to day 0 (28 days) was compared to frequency of migraine days from day 56-84 (final 28 days of study).

  Change in frequency of migraine days from day -28 to day 0 (28 days) was compared to frequency of migraine days from day 56-84 (final 28 days of study).

Study Arms (1)

Duloxetine

EXPERIMENTAL

Duloxetine 120mg daily for 12 weeks.

Drug: duloxetine

Interventions

duloxetine DRUG

Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)

Also known as: Cymbalta

Duloxetine

Eligibility Criteria

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

You may qualify if:

• Subject is male or female between the ages of 18 and 65, inclusive
• Subject has an IHS diagnosis of migraine with or without aura for at least one-year prior to screening
• Subject has experienced between 4 and 10 migraine headaches per month (inclusive) over the past six months, with at least 24 hours separating attacks
• Subject has less than 15 total headache days per month
• Subject is able to differentiate migraine attacks from other headache types, if applicable
• Subjects daily medications (for any indication) have remained at a stable dose for the 60 days preceding screening
• Subject is using or agrees to use for the duration of participation a medically acceptable form of contraception (as determined by investigator and mutually agreed upon with patient), if female of child-bearing potential
• Subjects currently taking a single agent for the prevention of migraine must be on a stable dose (unchanged for 2 months) prior to study entry
• Subject has negative urine pregnancy test prior to study entry, if female of child-bearing potential
• Subject is able to understand and comply with all study requirements
• Subject provides written informed consent prior to any screening procedures being conducted

You may not qualify if:

• Subjects with onset of migraine after 50 years of age
• Subjects who have been previously treated or are currently being treated with duloxetine
• Subjects who have failed greater than 3 adequate trials of other medications the prevention of migraine, as determined by investigator
• Subjects who have a known hypersensitivity to duloxetine or any of the inactive ingredients
• Subject has taken any medication which has been shown to be effective for migraine prophylaxis, on a daily basis within the 4 weeks prior to screening or at any time during participation in the study, for any indication.
• Subjects with a history of significant drug or alcohol abuse within the past year
• Subjects with major depressive disorder or who have had a suicidal ideation in the 3 months prior to screening or have a history of attempted suicide
• Subjects who have a Beck Depression Inventory score of \> 18 at screening
• Subjects who have \> 0 on question number 9 of Beck Depression Inventory (Suicidal Thoughts or Wishes question)
• Subjects who have participated in an investigational drug trial in the 30 days prior to the screening visit
• Subjects with a current or history of a hepatic or renal disorder
• Subjects with uncontrolled narrow angle glaucoma
• Subjects who have experienced significant side effects from two different SSRI and/or SNRI therapies, as determined by investigator
• Subjects with uncontrolled restless legs syndrome, as determined by investigator

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Jefferson Headache Center

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

This trial was uncontrolled. Five of the 27 subjects did not complete.

Results Point of Contact

• Title: William B Young, MD
• Organization: Thomas Jefferson University

william.b.young@jefferson.edu

215-955-2243

Study Officials

• William B. Young, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2007
• First Posted: March 6, 2007
• Study Start: August 1, 2007
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: May 26, 2014
• Results First Posted: May 26, 2014

Record last verified: 2014-04

Locations

US (1)