Neurotropin to Treat Fibromyalgia
This study will examine the safety and effectiveness of the experimental drug, neurotropin, for preventing or easing pain associated with fibromyalgia. A disorder that primarily affects women, fibromyalgia causes widespread aching and stiffness in muscles. Neurotropin has been used in Japan for many years to treat various chronic painful conditions, including fibromyalgia.
Women with fibromyalgia who have been treated unsuccessfully with standard therapy may be eligible for this study. Patients must have a history of widespread pain for more than half of the days in each of the three months before they enter the study. Candidates are screened with a medical history, physical examination, blood and urine tests, questionnaires and an electrocardiogram (EKG).
Participants take their usual medications for fibromyalgia in addition to either neurotropin or a placebo (look-alike medicine with no active ingredient). At 6 weeks and 12 weeks into the study, they return to the NIH Clinical Center for evaluation of their sensitivity to pain and level of physical capability. After 12 weeks, study subjects "cross-over" their medication; that is, patients who took neurotropin for the first 12 weeks of the study take placebo for the next 12 weeks, and vice-versa. Again, after 6 and 12 weeks, patients return for evaluation.
Participants have blood and urine tests six times during the study and complete questionnaires each week about their pain, symptoms, and activities.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Neurotropin Treatment of Fibromyalgia|
- Relief of pain and improvement in functional capacity. [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]
- Pain thresholds at specific tender points. [ Time Frame: 25 weeks. ] [ Designated as safety issue: No ]
|Study Start Date:||August 2006|
|Study Completion Date:||December 2015|
|Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Placebo Comparator: 1
Receive placebo for 12 weeks and then the active medication for 12 weeks, in random order.
Active Comparator: 2
Patients will receive the active medication for 12 weeks and then the placebo for 12 weeks, in random order.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00366535
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Leorey N Saligan, C.R.N.P.||National Institute of Nursing Research (NINR)|