Efficacy and Safety of Cyclobenzaprine Hydrochloride Extended Release for the Treatment of Chronic Migraine
Primary Purpose
Chronic Migraine
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
cyclobenzaprine hydrochloride
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Migraine focused on measuring migraine
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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 -
Sites / Locations
- The Headache Center at Kennedy Health Alliance
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
cyclobenzaprine hydrochloride
placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Mean total number of headache days/month
mean peak daily and mean average daily pain intensity ratings/month
mean total number of abortive treatment days/month
Full Information
NCT ID
NCT01151787
First Posted
June 25, 2010
Last Updated
July 24, 2014
Sponsor
Kennedy Medical Group
Collaborators
Teva Pharmaceuticals USA
1. Study Identification
Unique Protocol Identification Number
NCT01151787
Brief Title
Efficacy and Safety of Cyclobenzaprine Hydrochloride Extended Release for the Treatment of Chronic Migraine
Official Title
Efficacy and Safety of Cyclobenzaprine Hydrochloride Extended Release for the Treatment of Chronic Migraine: A Randomized, Double-Blind, Placebo-Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Terminated
Why Stopped
Study was never initiated under new location/provider group. Contract to continue was never signed between TEVA and Kennedy Headache Center
Study Start Date
July 2010 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kennedy Medical Group
Collaborators
Teva Pharmaceuticals USA
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Migraine
Keywords
migraine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cyclobenzaprine hydrochloride
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
cyclobenzaprine hydrochloride
Other Intervention Name(s)
cyclobenzaprine hydrochloride is Amrix 15mg/daily
Intervention Description
15mg daily for 3 months
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Mean total number of migraine/migrainous headache days per month
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Mean total number of headache days/month
Time Frame
4 months
Title
mean peak daily and mean average daily pain intensity ratings/month
Time Frame
4 months
Title
mean total number of abortive treatment days/month
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loretta Mueller, DO
Organizational Affiliation
Kennedy Medical Group dba The Headache Center at Kennedy Health Alliance
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Headache Center at Kennedy Health Alliance
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Cyclobenzaprine Hydrochloride Extended Release for the Treatment of Chronic Migraine
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