Last updated on November 2018

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


Brief description of study

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

Detailed Study 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.

Clinical Study Identifier: NCT02601586

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