drugset / Trial / NCT02620020
A Study to Determine the Efficacy and Safety of Fasinumab for the Treatment of Adults With Chronic Low Back Pain
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The main objective of the trial is to evaluate the efficacy of fasinumab compared to placebo as measured by the change from baseline in the average daily Low Back Pain Intensity (LBPI) Numerical Rating Scale (NRS). Secondary objectives of the study are to evaluate the efficacy of fasinumab compared to placebo as measured by: * Change from baseline in the Roland Morris disability questionnaire (RMDQ) total score * Change from baseline in the Patient Global Assessment (PGA) of Low Back Pain (LBP) score * Change from baseline in the average daily LBPI NRS score
Timeline
- Start
- 2016-01-26
- Primary completion
- 2017-02-03
- Completion
- 2017-09-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fasinumab | Monoclonal antibody | 6 mg | Subcutaneous |
| Subject | Fasinumab | Monoclonal antibody | 9 mg | Subcutaneous |
Indications
No indication recorded.