ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 87 of 105 for:    Recruiting, Not yet recruiting, Active, not recruiting, Unknown status Studies | Parkinson Disease | France

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02601586
Recruitment Status : Recruiting
First Posted : November 10, 2015
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: PR Oxycodone Drug: Levodopa Drug: Oxycodone Placebo Drug: Levodopa placebo Phase 2 Phase 3

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : September 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PR oxycodone

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
PR Oxycodone
Other Name: PR Oxycontin

Drug: Levodopa placebo
Active Comparator: levodopa

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
Levodopa
Other Name: Modopar

Drug: Oxycodone Placebo
Placebo of PR Oxycodone

Placebo Comparator: Placebo

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
Placebo of PR Oxycodone

Drug: Levodopa placebo



Primary Outcome Measures :
  1. Average pain intensity [ Time Frame: 8 weeks ]
    Change in average pain rated on visual analog scale (VAS) intensity between baseline and after 8 weeks


Secondary Outcome Measures :
  1. Maximal pain intensity [ Time Frame: 8 weeks ]
    Change of maximal pain intensity over the preceding week rated on the VAS

  2. Functional impact of pain" of the Brief Pain Inventory (BPI) [ Time Frame: 8 weeks ]
    Change in scores between Day 0 and Day 71(Day 71= 8 weeks of treatment)

  3. Neuropathic Pain Symptoms Inventory (NPSI) [ Time Frame: 8 weeks ]
    Change in scores between Day 0 and Day 71(Day 71= 8 weeks of treatment)

  4. McGill pain questionnaire (SFMPQ) [ Time Frame: 8 weeks ]
    Change in scores between Day 0 and Day 71(Day 71= 8 weeks of treatment)

  5. Depression and anxiety: the Hospital Depression and Anxiety (HAD) scale [ Time Frame: 8 weeks ]
    Change in scores between Day 0 and Day 71(Day 71= 8 weeks of treatment)

  6. Apathy: the Lille Apathy Rating Scale (LARS) [ Time Frame: 8 weeks ]
    Change in scores between Day 0 and Day 71(Day 71= 8 weeks of treatment)

  7. Fatigue : the Parkinson fatigue scale [ Time Frame: 8 weeks ]
    Change in scores between Day 0 and Day 71(Day 71= 8 weeks of treatment)

  8. Sleep : the Pittsburgh sleep quality index [ Time Frame: 8 weeks ]
    Change in scores between Day 0 and Day 71(Day 71= 8 weeks of treatment)

  9. Motor assessment and motor fluctuations: MDS UPDRS (MDS Movement Disorder Society - UPDRS Unified Parkinson Disease Rating Scale) [ Time Frame: 8 weeks ]
    Change in scores between Day 0 and Day 71(Day 71= 8 weeks of treatment)

  10. Quality of life: Parkinson's Disease Questionnaire 39 items (PDQ-39) [ Time Frame: 8 weeks ]
    Change in scores between Day 0 and Day 71(Day 71= 8 weeks of treatment)

  11. Acetaminophen consumption reported in diary [ Time Frame: 8 weeks ]
    number of pills or capsules reported in patients diary

  12. Adverse events [ Time Frame: Day 5, Day 10, Day 15, Day 43, Day 71, Day 79 ]
    Adverse events, evaluated with an open-ended questionnaire

  13. changes in Resting-state brain network (3T fMRI) [ Time Frame: Day 0 /Day 71(Day 71= 8 weeks of treatment) ]
    changes in resting-state cerebral networks between Day 0 and Day 71, as assessed by 3T fMRI.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 treated by deep brain stimulation
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02601586


Contacts
Contact: Marie-Elise LLAU 0561778771 ext +33 llau.me@chu-toulouse.fr
Contact: Charline DAGUZAN 0561778490 ext +33 daguzan.c@chu-toulouse.fr

Locations
France
Hospital of Aix-en-Provence Recruiting
Aix-en-Provence, France, 13616
Contact: Viallet, MD       fviallet@ch-aix.fr   
CHU Amiens Recruiting
Amiens, France, 80054
Contact: Krystkowiak, MD       krystkowiak.pierre@chu-amiens.fr   
University Hospital of Bordeaux Recruiting
Bordeaux, France, 33076
Contact: Tison, MD       francois.tison@chu-bordeaux.fr   
University Hospital of Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Durif , MD       fdurif@chu-clermontferrand.fr   
Henri Mondor Hospital Recruiting
Créteil, France, 94010
Contact: REMY, MD       neuro-philippe.remy@hmn.aphp.fr   
University Hospital of Lille Recruiting
Lille, France, 59037
Contact: Defevbre, MD       Luc.DEFEBVRE@CHRU-LILLE.FR   
University Hospital of Limoges Recruiting
Limoges, France, 87042
Contact: Torny       frederic.torny@chu-limoges.fr   
University Hospital of Marseille Recruiting
Marseille, France, 13385
Contact: Azulay       Jean-philippe.AZULAY@ap-hm.fr   
University Hospital of Nantes Recruiting
Nantes, France
Contact: Rouaud, MD       Tiphaine.Rouaud@chu-nantes.fr   
Pitié-Salpêtrière Hospital Recruiting
Paris, France, 75651
Contact: Corvol       jean-christophe.corvol@psl.aphp.fr   
University Hospital of Poitiers Recruiting
Poitiers, France, 86021
Contact: Houeto, MD       jean-luc.houeto@chu-poitiers.fr   
University Hospital of Rennes Recruiting
Rennes, France, 35033
Contact: Drapier, MD       Sophie.Drapier@chu-rennes.fr   
University Hospital of Rouen Recruiting
Rouen, France, 76031
Contact: Maltête, MD         
University Hospital of Strasbourg Recruiting
Strasbourg, France, 67098
Contact: Christine Tranchant, MD       Christine.Tranchant@chru-strasbourg.fr   
Chu Toulouse Recruiting
Toulouse, France, 31059
Contact: Christine BREFEL-COURBON, MD       christine.brefel-courbon@univ-tlse3.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Christine BREFEL-COURBON, MD CHU TOULOUSE
Study Chair: Claire THALAMAS, MD CHU TOULOUSE

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02601586     History of Changes
Other Study ID Numbers: 14 7440 01
First Posted: November 10, 2015    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Neuralgia
Pain
Neurologic Manifestations
Signs and Symptoms
Oxycodone
Levodopa
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action