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Therapeutic Areas: Neurology | Family Medicine
Disease Category: Migraine and Cluster Headaches
Location: United States, NJ

Clinical Trial Details

Overview

Research Study Summary

Chronic Migraine Research Study for Subjects with Headaches at least 15 days per Month.

Purpose

Efficacy and Safety of Cyclobenzaprine Hydrochloride Extended-Release for the Treatment of Chronic Migraine: A Randomized, Double-Blind, Placebo-Controlled Trial. Subjects keep 4 weeks of a baseline headache diary before starting study medication, then 12 weeks of diaries during the treatment phase of the study. Subjects may remain on most daily and "as needed" medications with few exceptions. Details are on http://theuniversitydoctors.com/headache

Patient Inclusion Criteria:

  • Age 18 to 65
  • Headaches (lasting >30 mins) meeting chronic migraine criteria [(>15 days/mo headache, >8 days of these has with at least 1 migrainous feature OR which are alleviated with triptans or ergots [unilaterality or pain more prominent on 1 side of head, throbbing, nausea, vomiting, photophobia, phonophobia, increased pain with or avoidance of physical exertion]
  • Subjects willing and able to perform all study-related measures

Patient Exclusion Criteria:

  • NOT experiencing new daily persistent headache (abruptly daily from onset), hemicrania continua (unilateral-locked), chronic tension-type headache (no migrainous features ever), cluster headache, or any headache suspicious for and not investigated to rule out secondary headache disorder
  • Women of childbearing potential using acceptable birth control for the duration of the study (OCs [started > 3 months prior to randomization], IUD, injectable or intravaginal contraceptive, or barrier methods combined with spemacide), not currently pregnant or nursing, and not planning pregnancy during the study
  • NOT having following medical conditions: angle closure glaucoma, urinary retention, hepatic impairment felt to interfere with study safety, history of myocardial infarction or congestive heart failure, arrhythmia, hyperthyroidism, or psychiatric condition which may interfere with study safety or data collection
  • NOT using concomitant tramadol, ultracet, ultram, tricyclic antidepressants, cyclobenzaprine, or MAO inhibitors (or have discontinued MAO inhibitors within last 14 days)
  • NO known allergy or previous serious reactions to cyclobenzaprine or any of Amrix formulation components
  • NO new preventive medications (which may influence headache) started within the last 2 months and NO adjustment of dosages within the last month of trial enrollment

To Learn more
Phase

4

Gender

Both Male and Female

Age

N/A

Overall Status

Recruiting

Facility Type

N/A

Contact

Loretta Mueller DO, FACOFP, Associate Professor UMDNJ/SOM
Rowan University School of Osteopathic Medicine
NMI
Headache Center
UDP #1700
42 E. Laurel Rd
Stratford, NJ 08084
Phone: 856-566-2706

View Map

CW ID: 178139

Date Last Changed: January 29, 2014


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