Chronic MigrainePhase 3NCT01151787
Efficacy and Safety of Cyclobenzaprine Hydrochloride Extended Release for the Treatment of Chronic Migraine
A Phase 3 study testing cyclobenzaprine hydrochloride in people with Chronic Migraine, run by Kennedy Medical Group at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Migraine
- What is being tested?
- cyclobenzaprine hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Sep 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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 -
Trial locations and contacts
1 site in 1 country.
United States1 site
The Headache Center at Kennedy Health Alliance
Cherry Hill, New Jersey, 08002
About this study
Official title: 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.
- Conditions
- Chronic Migraine
- Being tested
- cyclobenzaprine hydrochloride, placebo
- Keywords
- migraine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclobenzaprine hydrochlorideDrug
Also called cyclobenzaprine hydrochloride is Amrix 15mg/daily
15mg daily for 3 months
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| cyclobenzaprine hydrochloride | Active comparator | Not described Receives: Drug: cyclobenzaprine hydrochloride |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (3)
Mean total number of headache days/month
Measured: 4 months
mean peak daily and mean average daily pain intensity ratings/month
Measured: 4 months
mean total number of abortive treatment days/month
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionSep 2013
- Study completionSep 2013
Why it stopped: Study was never initiated under new location/provider group. Contract to continue was never signed between TEVA and Kennedy Headache Center
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kennedy Medical Group
- Sponsor type
- University, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Responsible party
- Sponsor
- Investigators
- Loretta Mueller, DO, Principal investigator, Kennedy Medical Group dba The Headache Center at Kennedy Health Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151787
- Sponsor's protocol ID
- CEPH03242010
- Status last verified
- Jul 2014
- First submitted
- 25 Jun 2010
- Last updated
- 25 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Cyclobenzaprine Hydrochloride Extended Release for the Treatment of Chronic Migraine: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT01151787
- Acronym / sponsor ID
- CEPH03242010
- Conditions
- Chronic Migraine
- Keywords
- migraine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was never initiated under new location/provider group. Contract to continue was never signed between TEVA and Kennedy Headache Center
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Kennedy Medical GroupUniversity, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Study start
- Jul 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 28 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cyclobenzaprine hydrochloride | Active comparator | Drug: cyclobenzaprine hydrochloride |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cyclobenzaprine hydrochlorideAlso: cyclobenzaprine hydrochloride is Amrix 15mg/daily15mg daily for 3 months | Drug | cyclobenzaprine hydrochloride |
| placeboplacebo | Drug | placebo |
Primary outcome
Mean total number of migraine/migrainous headache days per month
Time frame: 4 months
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.
3 secondary outcomes
Mean total number of headache days/month
Time frame: 4 months
mean peak daily and mean average daily pain intensity ratings/month
Time frame: 4 months
mean total number of abortive treatment days/month
Time frame: 4 months
Results and safety
The study was stopped early (reason given: Study was never initiated under new location/provider group. Contract to continue was never signed between TEVA and Kennedy Headache Center). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loretta Mueller, DO principal investigator
Kennedy Medical Group dba The Headache Center at Kennedy Health Alliance
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cyclobenzaprine hydrochloride in people with Chronic Migraine, run by Kennedy Medical Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study was never initiated under new location/provider group. Contract to continue was never signed between TEVA and Kennedy Headache Center). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean total number of migraine/migrainous headache days per month (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2014.