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A Research Study Examining The Use Of Duloxetine In The Prevention Of Migraine Headache
This study is currently recruiting participants.
Verified May 2011 by Thomas Jefferson University

First Received on March 5, 2007.   Last Updated on May 19, 2011   History of Changes
Sponsor: Thomas Jefferson University
Information provided by: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00443352
  Purpose

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.


Condition Intervention Phase
Migraine
Drug: duloxetine
Phase IV

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Single-Center, Open Label Pilot Study Examining The Use Of Duloxetine In The Prevention Of Episodic Migraine

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Change in frequency of migraine days during the last 28 day interval of the treatment period as compared to the 28 day baseline period. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: August 2007
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Duloxetine Drug: duloxetine
Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
Other Name: Cymbalta

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

EXCLUSION CRITERIA:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00443352

Contacts
Contact: Meryl Latsko, MD, MPH 215-955-9477 meryl.latsko@jefferson.edu

Locations
United States, Pennsylvania
Jefferson Headache Center Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Meryl Latsko, MD, MPH     215-955-9477     Meryl.Latsko@jefferson.edu    
Principal Investigator: William B. Young, MD            
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: William B. Young, MD Thomas Jefferson University
  More Information

No publications provided

Responsible Party: Stephen D. Silberstein, MD, Jefferson Headache Center/Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00443352     History of Changes
Other Study ID Numbers: Protocol #: F1J-MC-I
Study First Received: March 5, 2007
Last Updated: May 19, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Duloxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012