Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2025-12-24 @ 1:21 PM
NCT ID:
NCT01041495
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01041495
Study Brief:
Protocol Section:
NCT01041495