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

This study has been terminated.
(Study was never initiated under new location/provider group. Contract to continue was never signed between TEVA and Kennedy Headache Center)
Sponsor:
Collaborator:
Teva Pharmaceuticals USA
Information provided by (Responsible Party):
Kennedy Medical Group
ClinicalTrials.gov Identifier:
NCT01151787
First received: June 25, 2010
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Chronic Migraine
Drug: cyclobenzaprine hydrochloride
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of Cyclobenzaprine Hydrochloride Extended Release for the Treatment of Chronic Migraine: A Randomized, Double-Blind, Placebo-Controlled Trial

Resource links provided by NLM:


Further study details as provided by Kennedy Medical Group:

Primary Outcome Measures:
  • Mean total number of migraine/migrainous headache days per month [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • mean peak daily and mean average daily pain intensity ratings/month [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • mean total number of abortive treatment days/month [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: July 2010
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: cyclobenzaprine hydrochloride Drug: cyclobenzaprine hydrochloride
15mg daily for 3 months
Other Name: cyclobenzaprine hydrochloride is Amrix 15mg/daily
Placebo Comparator: placebo Drug: placebo
placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01151787

Locations
United States, New Jersey
The Headache Center at Kennedy Health Alliance
Cherry Hill, New Jersey, United States, 08002
Sponsors and Collaborators
Kennedy Medical Group
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Loretta Mueller, DO Kennedy Medical Group dba The Headache Center at Kennedy Health Alliance
  More Information

No publications provided

Responsible Party: Kennedy Medical Group
ClinicalTrials.gov Identifier: NCT01151787     History of Changes
Other Study ID Numbers: CEPH03242010
Study First Received: June 25, 2010
Last Updated: July 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Kennedy Medical Group:
migraine

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cyclobenzaprine
Amitriptyline
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Tranquilizing Agents
Central Nervous System Depressants
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014