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

• Register: ClinicalTrials.gov
• Last refreshed on: 14 March 2022
• Main ID: NCT02601586
• Date of registration: 17/08/2015
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Toulouse
• Public title: Effects of PR Oxycodone and of Levodopa, vs Placebo, on Central Neuropathic Pain in Parkinson's Disease OXYDOPA
• Scientific 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
• Date of first enrolment: September 2016
• Target sample size: 67
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02601586
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2/Phase 3

Countries of recruitment

France

Contacts

• Name: Christine BREFEL-COURBON, MD
• Affiliation: CHU Toulouse

• Name: Claire THALAMAS, MD
• Affiliation: CHU Toulouse

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- Patients treated with antiemetic neuroleptics

- Patients with angle-closure glaucoma

Exclusion criteria relating to MRI:

- Patients with claustrophobia

- Patients with a hearing aid, cardiac prosthesis, pacemaker, surgical clip

- Patients refusing to be informed of abnormalities are detected on MRI



Age minimum: 40 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: Oxycodone Placebo

Drug: Levodopa

Drug: PR Oxycodone

Drug: Levodopa placebo

Primary Outcome(s)

Average pain intensity [Time Frame: 8 weeks]

Secondary Outcome(s)

Acetaminophen consumption reported in diary [Time Frame: 8 weeks]

Depression and anxiety: the Hospital Depression and Anxiety (HAD) scale [Time Frame: 8 weeks]

changes in Resting-state brain network (3T fMRI) [Time Frame: Day 0 /Day 71(Day 71= 8 weeks of treatment)]

Functional impact of pain" of the Brief Pain Inventory (BPI) [Time Frame: 8 weeks]

Sleep : the Pittsburgh sleep quality index [Time Frame: 8 weeks]

Adverse events [Time Frame: Day 5, Day 10, Day 15, Day 43, Day 71, Day 79]

Apathy: the Lille Apathy Rating Scale (LARS) [Time Frame: 8 weeks]

Fatigue : the Parkinson fatigue scale [Time Frame: 8 weeks]

Maximal pain intensity [Time Frame: 8 weeks]

McGill pain questionnaire (SFMPQ) [Time Frame: 8 weeks]

Neuropathic Pain Symptoms Inventory (NPSI) [Time Frame: 8 weeks]

Motor assessment and motor fluctuations: MDS UPDRS (MDS Movement Disorder Society - UPDRS Unified Parkinson Disease Rating Scale) [Time Frame: 8 weeks]

Quality of life: Parkinson's Disease Questionnaire 39 items (PDQ-39) [Time Frame: 8 weeks]

Secondary ID(s)

14 7440 01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors