drugset / Trial / NCT01435798
Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan Dose Response Clinical Trial
Phase 2
Completed
26 enrolled
Brigham and Women's Hospital
National Institute of Neurological Disorders and Stroke (NINDS) · collab
RandomizedCrossoverQuadruple-blindTreatment
Summary
This randomized, placebo-controlled, double-blind 4x4 crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of three doses of chronic oral (PO) dextromethorphan compared to placebo in central neuropathic pain following spinal cord injury. Subjects' maximally tolerated doses (MTD) were first determined to establish individual dose-analgesic response relationships in a run-in period; following a washout period, subjects were then randomized to receive an order of four doses of dextromethorphan (including placebo) in a 4x4 Latin square cross-over design.
Timeline
- Start
- 2003-04
- Primary completion
- 2008-01
- Completion
- 2008-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dextromethorphan | Unknown | 25 % | Oral |
| Subject | Dextromethorphan | Unknown | 50 % | Oral |
| Subject | Dextromethorphan | Unknown | 100 % | Oral |