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: A Randomized, Double-Blind, Placebo-Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Migraine
• Intervention / Treatment: Drug: placebo; Drug: cyclobenzaprine hydrochloride

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08002
      • The Headache Center at Kennedy Health Alliance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: placebo; placebo
Active Comparator: cyclobenzaprine hydrochloride	Drug: cyclobenzaprine hydrochloride; 15mg daily for 3 months; Other Names: cyclobenzaprine hydrochloride is Amrix 15mg/daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Kennedy Medical Group
• Collaborators: Teva Pharmaceuticals USA
• Investigators: Principal Investigator: Loretta Mueller, DO, Kennedy Medical Group dba The Headache Center at Kennedy Health Alliance

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: June 25, 2010
• First Submitted That Met QC Criteria: June 25, 2010
• First Posted (Estimate): June 28, 2010

Study Record Updates

• Last Update Posted (Estimate): July 25, 2014
• Last Update Submitted That Met QC Criteria: July 24, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: migraine
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Tranquilizing Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Antidepressive Agents, Tricyclic; Neuromuscular Agents; Adrenergic Uptake Inhibitors; Muscle Relaxants, Central; Amitriptyline; Cyclobenzaprine
• Other Study ID Numbers: CEPH03242010