Study Stopped
Study was never initiated under new location/provider group. Contract to continue was never signed between TEVA and Kennedy Headache Center
Efficacy and Safety of Cyclobenzaprine Hydrochloride Extended Release for the Treatment of Chronic Migraine
1 other identifier
interventional
35
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2010
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2010
CompletedFirst Posted
Study publicly available on registry
June 28, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedJuly 25, 2014
July 1, 2014
3.2 years
June 25, 2010
July 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
Mean total number of headache days/month
4 months
mean peak daily and mean average daily pain intensity ratings/month
4 months
mean total number of abortive treatment days/month
4 months
Study Arms (2)
cyclobenzaprine hydrochloride
ACTIVE COMPARATORplacebo
PLACEBO COMPARATORInterventions
15mg daily for 3 months
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kennedy Medical Grouplead
- Teva Pharmaceuticals USAcollaborator
Study Sites (1)
The Headache Center at Kennedy Health Alliance
Cherry Hill, New Jersey, 08002, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Loretta Mueller, DO
Kennedy Medical Group dba The Headache Center at Kennedy Health Alliance
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2010
First Posted
June 28, 2010
Study Start
July 1, 2010
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
July 25, 2014
Record last verified: 2014-07