Effects of PR Oxycodone and of Levodopa, vs Placebo, on Central Neuropathic Pain in Parkinson's Disease — OXYDOPA  

Parkinson Disease Clinical Trial

Official title: Evaluation of the Analgesic Effects of Prolonged-release Oxycodone and of Levodopa, Versus Placebo, on Central Neuropathic Pain in Parkinson's Disease: OXYDOPA Trial

Status Completed

Clinical Trial Summary

This study will be conducted in three parallel groups receiving oxycodone, levodopa or placebo, administered as an add-on therapy, in addition to the usual antiparkinsonian treatment. As this study focuses on chronic central neuropathic pain caused by PD, the effects of study treatments will be evaluated after a 10-week treatment period

Clinical Trial Description

The treatment period (11 weeks) will be divided into three periods: 1. A titration phase of two weeks, during which of the doses of the treatments will be gradually increased in three steps: Level 1 (from D1 to D5): - Oxycodone: 10 mg PR/day bid (5 mg PR/5 mg PR) - Levodopa: 100 mg/day bid (50 mg/50 mg) Level 2 (from D6 to D10): - Oxycodone: 20 mg PR/day tid (10 mg/0 mg/10 mg) - Levodopa: 150 mg/day tid (50 mg/50 mg/50 mg) Level 3 (from D11to D15): - Oxycodone: 40 mg PR/day tid (20 mg/0 mg/20 mg) - Levodopa: 200 mg/day tid (100 mg/50 mg/50 mg) 2. A fixed dose period: the level 3 dose will be maintained for 8 weeks (from D16 to D71). The study treatment will be administered as an add-on therapy, with the usual antiparkinsonian treatment. If patients have side effects at the level 3 dose, a return to the level 2 dose will be authorized. 3. A withdrawal period: The dose of the study treatment will gradually be reduced, over an eight-day period: For patients treated with the level 3 dose for 8 weeks: decrease to the level 2 dose over the first 3 days (from D72 to D74) ; then a decrease to the level 1 dose over the next 3 days (from D75 to D77). The treatment will be stopped completely on D78. The last visit will take place on D79, 2 days after the end of treatment. For patients treated with the level 2 dose: decrease to the level 1 dose over the first 3 days (from D72 to D74), with stopping of the treatment on D75. The last visit will take place on D79, 5 days after the end of treatment. ;

Related Conditions & MeSH terms

• Neuralgia
• Parkinson Disease

• NCT number: NCT02601586
• Study type: Interventional
• Source: University Hospital, Toulouse
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 2016
• Completion date: November 2020