At a glance
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The Use of Topical Baclofen, Amitriptyline HCI, and Ketamine (BAK) in a PLO Gel vs. Placebo for the Treatment of Chemotherapy Induced Peripheral Neuropathy: A Phase III Randomized Double-Blind Placebo Controlled Study
In Brief
A Phase 3 clinical trial evaluating baclofen/amitriptyline/ketamine gel and placebo for Chronic Myeloproliferative Disorders and 9 related conditions. Completed, enrolled 208 participants across 165 sites.
Detailed Summary
RATIONALE: Baclofen-amitriptyline-ketamine (BAK) gel may lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether BAK gel is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy . PURPOSE: This randomized phase III trial is studying BAK gel to see how well it works compared with a placebo in treating peripheral neuropathy caused by chemotherapy in patients with cancer.
Study Details
Timeline
Interventions
Applied topically
Applied topically