Efficacy and Safety of Cyclobenzaprine Hydrochloride Extended Release for the Treatment of Chronic Migraine

Chronic Migraine Clinical Trial

Official title:

Efficacy and Safety of Cyclobenzaprine Hydrochloride Extended Release for the Treatment of Chronic Migraine: A Randomized, Double-Blind, Placebo-Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01151787
• Other study ID #: CEPH03242010
• Status: Terminated
• Phase: Phase 3
• First received: June 25, 2010
• Last updated: July 24, 2014
• Start date: July 2010
• Est. completion date: September 2013

Study information

• Verified date: July 2014
• Source: Kennedy Medical Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 -

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine Disorders

Intervention

Drug:
• cyclobenzaprine hydrochloride
15mg daily for 3 months
• placebo
placebo

Locations

Country	Name	City	State
United States	The Headache Center at Kennedy Health Alliance	Cherry Hill	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Kennedy Medical Group	Teva Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean total number of migraine/migrainous headache days per month	The principle outcome variable will be the mean total number of migraine/migrainous headache days which will be calculated for the month prior to enrollment in the study (pretreatment) and then calculated for the third month after study treatment (posttest) after taking 15mg of Amrix or the placebo.	4 months	No
Secondary	Mean total number of headache days/month		4 months	No
Secondary	mean peak daily and mean average daily pain intensity ratings/month		4 months	No
Secondary	mean total number of abortive treatment days/month		4 months	No