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:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT01328002
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of primary fibromyalgia
* 13-17 years of age
* To be eligible for screening, have average pain rating in the previous week of at least 3 but no more than 9 on an 11-point numeric rating scale
* To be eligible to enter into the open-label treatment period, have a 1-week mean of daily pain ratings of at least 3 but no more than 9 (11-point numeric rating scale) in the week before Baseline (Visit 2)
* To be eligible for randomization and entry into the double-blind treatment period, have a decrease of at least 50% in 1-week mean of daily pain ratings (11-point numeric rating scale) before Randomization (Visit 7) compared with the 1-week mean of daily pain ratings, in the week before Baseline (Visit 2)
* Unsatisfactory response to nonpharmacologic fibromyalgia treatment.
Exclusion Criteria:
* Severe psychiatric illness
* Severe renal impairment
* Evidence of active liver disease
* Pregnant or breastfeeding
* Significant risk of suicidality
* Unable, unwilling or inadvisable to discontinue prohibited medications
* History of alcohol abuse or drug abuse or dependence, within previous year
* Current systemic infection
* Autoimmune disease
* History of seizure disorder (other than febrile seizures)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
17 Years
Study:
NCT01328002
Study Brief:
Protocol Section:
NCT01328002