Status:
TERMINATED
Efficacy and Safety of Cyclobenzaprine Hydrochloride Extended Release for the Treatment of Chronic Migraine
Lead Sponsor:
Kennedy Medical Group
Collaborating Sponsors:
Teva Pharmaceuticals USA
Conditions:
Chronic Migraine
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The primary objective of the study is to evaluate the effectiveness and safety of cyclobenzaprine hydrochloride extended release (Amrix 15mg/day) for the prophylaxis of chronic migraine compared to a ...
Eligibility Criteria
Inclusion
- males and females, aged 18 to 65, with headaches longer than 30 minutes per day for at least 15 days per month (28 days) meeting ICHD-IIR criteria for chronic migraine. Subjects must have headaches at least 8 days per month which are alleviated with triptans or ergots AND/OR which have at least 1 migrainous feature (unilaterality of headache or pain more prominent on 1 side of the head, throbbing, nausea, vomiting, photophobia, phonophobia, increased pain with physical exertion or avoidance of exertion)
- subjects willing and able to perform all study-related measures including accurately completing study diaries and instruments, maintaining stable doses of headache preventative medications, completing study visits and obtaining blood testing as indicated.
- women of childbearing potential must use an acceptable method of birth control for the duration of the study (oral contraceptives, IUD, injectable or intravaginal contraception or barrier methods combined with spermicide)
Exclusion
- subjects \<18 and \>65 years of age
- pregnancy or attempted pregnancy during the study
- nursing females
- psychiatric condition which, in the investigator's opinion will influence trial safety or data collection
- new daily persistent headache, hemicrania continua, chronic tension-type headache or cluster headache diagnoses.
- headache suspicious for and not investigated to rule out secondary headache disorder
- angle closure glaucoma
- urinary retention
- hepatic impairment felt by the investigator to interfere with study safety (as determined from history and/or prerequisite liver function testing within 1 year of study enrollment)
- within 14 days of MAO inhibitor use or discontinuation
- known hypersensitivity to cyclobenzaprine hydrochloride or any component of Amrix formulation
- concomitant tramadol or tricyclic antidepressant use
- history of myocardial infarction or congestive heart failure
- hyperthyroidism
- new start of daily preventative medication (which may influence headaches) less than 2 months preceding enrollment
- dosage change or discontinuation of daily preventative medication (which may influence headaches) within 1 month of trial enrollment -
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01151787
Start Date
July 1 2010
End Date
September 1 2013
Last Update
July 25 2014
Active Locations (1)
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1
The Headache Center at Kennedy Health Alliance
Cherry Hill, New Jersey, United States, 08002