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

NCT02601586 | Completed Phase 2

• 1 other identifier: 14 7440 01
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 18

Brief 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

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Average pain intensity

  Change in average pain rated on visual analog scale (VAS) intensity between baseline and after 8 weeks

  8 weeks

Secondary Outcomes (13)

• Maximal pain intensity

  8 weeks

• Functional impact of pain" of the Brief Pain Inventory (BPI)

  8 weeks

• Neuropathic Pain Symptoms Inventory (NPSI)

  8 weeks

• McGill pain questionnaire (SFMPQ)

  8 weeks

• Depression and anxiety: the Hospital Depression and Anxiety (HAD) scale

  8 weeks

Study Arms (3)

PR oxycodone

EXPERIMENTAL

A titration phase of two weeks, in three steps: Level 1 (from D1 to D5): * Oxycodone : 10 mg PR/day bid (5 mg PR/5 mg PR) * Levodopa placebo 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 placebo: 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 placebo: 200 mg/day tid (100 mg/50 mg/50 mg) * A fixed dose period: the level 3 dose will be maintained for 8 weeks (from D16 to D71). * A withdrawal period:

Drug: PR Oxycodone; Drug: Levodopa placebo

levodopa

ACTIVE COMPARATOR

A titration phase of two weeks, in three steps: Level 1 (from D1 to D5): * Oxycodone placebo : 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 placebo: 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 placebo: 40 mg PR/day tid (20 mg/0 mg/20 mg) * Levodopa : 200 mg/day tid (100 mg/50 mg/50 mg) * A fixed dose period: the level 3 dose will be maintained for 8 weeks (from D16 to D71). * A withdrawal period:

Drug: Levodopa; Drug: Oxycodone Placebo

Placebo

PLACEBO COMPARATOR

A titration phase of two weeks, in three steps: Level 1 (from D1 to D5): * Oxycodone placebo : 10 mg PR/day bid (5 mg PR/5 mg PR) * Levodopa placebo 100 mg/day bid (50 mg/50 mg) Level 2 (from D6 to D10): * Oxycodone placebo: 20 mg PR/day tid (10 mg/0 mg/10 mg) * Levodopa placebo: 150 mg/day tid (50 mg/50 mg/50 mg) Level 3 (from D11to D15): * Oxycodone placebo: 40 mg PR/day tid (20 mg/0 mg/20 mg) * Levodopa placebo: 200 mg/day tid (100 mg/50 mg/50 mg) * A fixed dose period: the level 3 dose will be maintained for 8 weeks (from D16 to D71). * A withdrawal period:

Drug: Oxycodone Placebo; Drug: Levodopa placebo

Interventions

PR Oxycodone DRUG

PR Oxycodone

Also known as: PR Oxycontin

PR oxycodone

Levodopa DRUG

Levodopa

Also known as: Modopar

levodopa

Oxycodone Placebo DRUG

Placebo of PR Oxycodone

Placebo; levodopa

Levodopa placebo DRUG

PR oxycodone; Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Parkinson's disease according to the UKPDSBB (United Kingdom Parkinson's Disease Society Brain Bank) criteria
• Patients suffering from chronic pain (lasting for more than 3 months)
• Patients suffering from central neuropathic pain caused by PD,
• Patients with a PD-related central neuropathic pain intensity of at least 3 points on the VAS (average intensity over the last month),
• Patients with both types of pain (neuropathic and nociceptive) will be included if the neuropathic pain predominates
• Patients treated with a stable regimen of dopaminergic drugs (levodopa and/or dopamine agonists) for at least 4 weeks before the study dan throughout the study
• Patients with a stable step 1 analgesic (NSAIDS, acetaminophen) or coanalgesic (antidepressants, antiepileptic) treatment for at least 4 weeks before the study and throughout the study

You may not qualify if:

• Patients suffering from another parkinsonian syndrome
• De Novo patients (patients never before treated with dopaminergic drugs)
• Patients with intercurrent acute pain
• Patients suffering from a chronic disease causing pain (rheumatoid arthritis, ankylosing spondylitis, diabetic neuropathy, cancer etc.)
• Patients treated with neuroleptics
• Patients with clinically detectable behavioural disorders and addiction
• Patients with disabling dyskinesias
• Patients with painful restless legs syndrome
• Patients with cognitive impairment (MMS \< 25) or unable to complete the various scales used in the study
• Hypersensitivity to oxycodone, levodopa, benserazide or a combination of these drugs
• Patients treated with opioid drugs (step 2 and 3)
• Patients treated with non-selective monoamine oxidase inhibitors (MAOI)
• Patients with severe hepatocellular insufficiency
• Patients with uncontrolled cardiovascular and pulmonary diseases
• Persistent constipation that has already resulted in a subocclusive state

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (18)

Hospital of Aix-en-Provence

Aix-en-Provence, 13616, France

Location

CHU Amiens

Amiens, 80054, France

Location

University Hospital of Bordeaux

Bordeaux, 33076, France

Location

University Hospital of Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Henri Mondor Hospital

Créteil, 94010, France

Location

University Hospital of Lille

Lille, 59037, France

Location

University Hospital of Limoges

Limoges, 87042, France

Location

Hospital Pierre Wertheimer

Lyon, France

Location

University Hospital of Marseille

Marseille, 13385, France

Location

University Hospital of Nancy

Nancy, France

Location

University Hospital of Nantes

Nantes, France

Location

University Hospital of Nîmes - Caremeau

Nîmes, France

Location

Pitié-Salpêtrière Hospital

Paris, 75651, France

Location

University Hospital of Poitiers

Poitiers, 86021, France

Location

University Hospital of Rennes

Rennes, 35033, France

Location

University Hospital of Rouen

Rouen, 76031, France

Location

University Hospital of Strasbourg

Strasbourg, 67098, France

Location

Chu Toulouse

Toulouse, 31059, France

Location

Related Publications (2)

• Brefel-Courbon C, Harroch E, Marques A, Devos D, Thalamas C, Rousseau V, Ory-Magne F, Fabbri M, Maltete D, Rouaud T, Drapier S, Tir M, Thobois S, Salhi H, Corvol JC, Castelnovo G, Lagha-Boukbiza O, Fluchere F, Frismand S, Ansquer S, Sommet A, Rascol O. Oxycodone or Higher Dose of Levodopa for the Treatment of Parkinsonian Central Pain: OXYDOPA Trial. Mov Disord. 2024 Sep;39(9):1533-1543. doi: 10.1002/mds.29878. Epub 2024 Jun 8.

  PMID: 38850081 RESULT

• Lawn T, Rukavina K, Malcangio M, Howard M, Chaudhuri KR. Response to Mylius et al. Pain. 2022 Mar 1;163(3):e496-e497. doi: 10.1097/j.pain.0000000000002445. No abstract available.

  PMID: 35148289 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Levodopa; benserazide, levodopa drug combination

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine

Study Officials

• Christine BREFEL-COURBON, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

• Claire THALAMAS, MD

  University Hospital, Toulouse

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2015
• First Posted: November 10, 2015
• Study Start: September 1, 2016
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

FR (18)