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Neurotropin Treatment of Fibromyalgia
NCT00366535Phase 2
Key facts
- Status
- Completed
- Start
- Aug 2006
- Primary completion
- Dec 2015
- Countries
- 1
- Sponsor
- National Institute of Nursing Research
- Modality
- Biologic
- Conditions
- fibromyalgia (FM)
01
Overview
Phase 2, randomised, double-blind trial of vaccinia virus-inoculated rabbit skin extract in fibromyalgia (FM) (2 arms), sponsored by National Institute of Nursing Research. Primary endpoint: Fibromyalgia Impact Questionnaire at 25 weeks. Started Aug 2006; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Placebo first, then Neurotropin
Placebo for 12 weeks -> Washout -> Neurotropin for 12 weeks
Neurotropin first, then Placebo
Neurotropin for 12 weeks -> Washout -> Placebo for 12 weeks
03
Who it enrols
Women with fibromyalgia (ACR criteria) who have failed standard therapy, have widespread pain >50% of days in prior 3 months, 11/18 tender points, and FIQ > 30. Excludes pregnancy, HIV, and other pain causes.
04
Endpoints
Primary
Fibromyalgia Impact Questionnaire
Secondary
Sensitivity to Pain
Level of Physical Capability
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