| City: |
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Syracuse |
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State:
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NY |
| Zip Code: |
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13210 |
| Conditions: |
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Fibromyalgia - Pain - Sleep - Fatigue |
| Purpose: |
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Amrix (Cyclobenzaprine hydrochloride Extended release capsules) is approved by the FDA as a
muscle relaxant, indicated for the treatment of muscle spasm associated with acute, painful
musculoskeletal conditions. Cyclobenzaprine ER (Amrix TM) has a distinct pharmacokinetic
profile providing early systemic exposure and consistent plasma concentration over several
hours. Overall, a single dose of Amrix 30 mg is similar to that of cyclobenzaprine immediate
release 10 mg three times daily. This ER formula should improve compliance, with similar
efficacy and possibly less side effects as is often the case with slower release
formulations.
There are clinical studies showing that cyclobenzaprine can alleviate pain secondary to
Fibromyalgia induced muscle tone. This multi-layered evidence base suggests that
cyclobenzaprine may be able to alleviate pain in fibromyalgia. Theoretically in
fibromyalgia, pain is interpreted centrally and possibly occurs due to said muscle spasm .
Cyclobenzaprine may relieve this pain, thus allowing patients to function better during the
day and sleep better at night. Cyclobenzaprine has tricyclic antidepressant structure which
may also allow pain signal dampening in the spinal cord as well, similar to amitriptyline
which is used off-label for neuropathic pain as well.
Fibromyalgia (FM) is an illness that may involve medical, rheumatologic, autoimmune, sleep,
endocrine and psychiatric pathology. It is a syndrome of recurrent pain at trigger points.
Greater than 90% of these patients will report fatigue as a key symptom as well. There are
several investigation lines into the treatment of FM induced pain. Exercise, behavioral
therapy, amitryptiline, duloxetine, tramadol, sodium oxybate, pregabalin all have randomized
trials and almost all focus on pain. There are very few studies evaluating cyclobenzaprine
and none studying to Cyclobenzaprine ER formulation. None evaluate pain reduction, sleep
and fatigue improvement.
Cyclobenzaprine is a drug with minimal adverse effects (dry mouth, dizziness, fatigue,
constipation, somnolence, nausea, and dyspepsia). It may have a safer tolerability profile
than some of the FM medications noted above. As cyclobenzaprine is often studied and often
added as an augmentation agent to patients' regimens who suffer from acute painful
musculoskeletal conditions, the authors feel that cyclobenzaprine would also be effective in
this population. The authors wish to conduct a study to determine if cyclobenzaprine ER is
safe and tolerable in the treatment of FM induced pain, and secondary fatigue and insomnia.
This initial study may allow for continued regulatory studies with this product in FM
subjects. The authors propose a double-blind placebo controlled study to determine if
cyclobenzaprine ER is safe and effective in reversing FM induced pain, and secondary fatigue
and insomnia.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
If possible, 60 subjects will be included in this study.
- All males/females of any race are eligible if aged between 18 and 65 and
- Subjects must speak English and have capacity to receive and utilize informed consent
- Agree to use barrier method contraception or are infertile x 2 years due to medical
condition or surgery
- Have been formally diagnosed by a Board Certified Rheumatologist using the ACR 1990
research criteria for fibromyalgia
- Report that pain is a key distressing symptom of their FM
- Have a score of > 4 on the Visual Analogue Pain Scale (VAPS)
Exclusion Criteria: Subjects cannot
- Be pregnant or be attempting to conceive at present (urine bHCG must be negative)
- Have an active substance abuse problem with last use within the past 90 days (outside
of nicotine)
- Use cardiac QTc prolonging medications i.e., tricyclic antidepressants
- Use p4502D6 major inhibiting medications as cyclobenzaprine levels may increase
- Have a known medical condition outside of FM that causes pain, i.e., diabetic
neuropathy
- Have a known medical condition or other medication use that relatively
contraindicates cyclobenzaprine use (i.e., hypersensitivity concomitant use of
monoamine oxidase (MAO) inhibitors, seizures, known cardiac abnormalities, recent MI.
hepatitis, stroke, or psychosis
- Has a prior history of cyclobenzaprine use and failure (failure due to side effects
may be allowed at P.I. discretion)
- Be receiving daytime/nighttime sedating medication with clear chronological impact on
fatigue UNLESS fatigue predates sedating medication or said medication has been
steadily dosed > 4 weeks
- Other medications known to alleviate pain (i.e., Gabapentin, Pregabalin,
Amitryptiline, Duloxetine,Venlafaxine, Carbamazepine, Tramadol, etc) unless they have
been at steady dose more than 6 weeks |
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| Study is available at: |
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SUNY Upstate Medical University
Syracuse, NY 13210
United States
Primary Contact:
thomas l schwartz, md
Email: schwartt@upstate.edu
Phone: 315-464-3166
Secondary Contact:
thomas l schwartz, md
Email: schwartt@upstate.edu
Phone: 3154643166 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
this listing: |
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above to view all information about this clinical trial. |
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