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| 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 |
| 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 |
Inclusion Criteria:
EXCLUSION CRITERIA:
Contacts and Locations| Contact: Meryl Latsko, MD, MPH | 215-955-9477 | meryl.latsko@jefferson.edu |
| 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 | |
| Principal Investigator: | William B. Young, MD | Thomas Jefferson University |
More Information
| 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 |
|
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 |