Efficacy and Safety of Cyclobenzaprine Hydrochloride Extended Release for the Treatment of Chronic Migraine
Efficacy and Safety of Cyclobenzaprine Hydrochloride Extended Release for the Treatment of Chronic Migraine
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 placebo medication. A second objective, is to find out whether
 there is an improvement in quality of sleep and self-reported depression in patients taking
 Amrix 15mg daily. The hypothesis is that the number of migraine days per month of patients
 treated with Amrix 15mg daily will be significantly lower than those patients treated with
 placebo.
Inclusion Criteria:

 1. 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)

 2. 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.

 3. 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 Criteria:

 1. subjects <18 and >65 years of age

 2. pregnancy or attempted pregnancy during the study

 3. nursing females

 4. psychiatric condition which, in the investigator's opinion will influence trial safety
 or data collection

 5. new daily persistent headache, hemicrania continua, chronic tension-type headache or
 cluster headache diagnoses.

 6. headache suspicious for and not investigated to rule out secondary headache disorder

 7. angle closure glaucoma

 8. urinary retention

 9. 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)

 10. within 14 days of MAO inhibitor use or discontinuation

 11. known hypersensitivity to cyclobenzaprine hydrochloride or any component of Amrix
 formulation

 12. concomitant tramadol or tricyclic antidepressant use

 13. history of myocardial infarction or congestive heart failure

 14. hyperthyroidism

 15. new start of daily preventative medication (which may influence headaches) less than 2
 months preceding enrollment

 16. dosage change or discontinuation of daily preventative medication (which may influence
 headaches) within 1 month of trial enrollment -