Evaluation of the analgesic effects of prolonged-release oxycodone and of L-Dopa, versus placebo, on central neuropathic pain in Parkinson's disease : OXYDOPA trial

INTERVENTION: Trade Name: oxycontin LP 5mg Product Name: Oxycontin LP 5mg Pharmaceutical Form: Tablet INN or Proposed INN: oxycodone CAS Number: 124‐90‐3 Other descriptive name: OXYCODONE HYDROCHLORIDE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: oxycontin LP 10mg Product Name: Oxycontin LP 10mg Pharmaceutical Form: Tablet INN or Proposed INN: oxycodone CAS Number: 124‐90‐3 Other descriptive name: OXYCODONE HYDROCHLORIDE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: oxycontin LP 20mg Product Name: Oxycontin LP 20mg Pharmaceutical Form: Tablet INN or Proposed INN: oxycodone CAS Number: 124‐90‐3 Other descriptive name: OXYCODONE HYDROCHLORIDE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Modopar 125 Product Name: Modopar 125 Pharmaceutical Form: Capsule INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 150‐ INN or Proposed INN: BENSERAZIDE CAS Number: 322‐35‐0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25‐ Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Trade Name: Modopar 62,5 Product Name: Modopar 62,5 Pharmaceutical Form: Capsule INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Concentration unit: mg milligram(s) Concentration type: up to Concentration nu CONDITION: Central neuropathic pain in Parkinson's disease ; MedDRA version: 19.0 Level: LLT Classification code 10054095 Term: Neuropathic pain System Organ Class: 100000004852 Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] SECONDARY OUTCOME: Secondary end point(s): The secondary endpoints are: ; ‐The change in maximal pain intensity over the preceding week rated on the VAS (maximum ?VAS) between D0 and D71. ; ‐The proportion of patients experiencing at least 30% and 50% pain relief between D0 and D71 ; ‐The change in scores for various validated questionnaires of pain, behavior, quality of life and motor status between D0 and D71: ; ‐ Pain: “Functional impact of pain” of the Brief Pain Inventory (BPI); Neuropathic Pain Symptoms Inventory (NPSI); McGill pain questionnaire (SF‐MPQ) ; ‐ Depression and anxiety: the Hospital Depression and Anxiety (HAD) scale ; ‐ Apathy: the Lille Apathy Rating Scale (LARS) ; ‐ Fatigue : the Parkinson fatigue scale ; ‐ Sleep : the Pittsburg sleep quality index ; ‐ Motor assessment and motor fluctuations: MDS‐UPDRS ; ‐ Quality of life: Parkinson’s Disease Questionnaire 39 items (PDQ‐39) ; ‐Acetaminophen consumption (diary) ; ‐Adverse events, evaluated with an open‐ended questionnaire ; ; ‐The exploratory criterion will be the changes in resting‐state cerebral networks between D0 and D71, as assessed by 3T fMRI. Timepoint(s) of evaluation of this end point: The secondary endpoints are evaluated between between D0 and D71. ; The Acetaminophen consumption and the adverse events are evaluated pending the participation of each patient. INCLUSION CRITERIA: ‐Patients with Parkinson’s disease according to the UKPDSBB criteria ‐Patients aged 40 to 75 years (male or female) ‐Patients suffering from chronic pain (lasting for more than 3 months) ‐Patients suffering from central neuropathic pain caused by PD, as identified with a two‐part clinical questionnaire: PRIMARY OUTCOME: Main Objective: The main objective of this study is to evaluate the respective effects of two drugs, oxycodone and levodopa, administered over a period of 8 weeks at stable dosage, versus placebo, on PD‐related central neuropathic pain intensity (average intensity over the preceding week) in PD patients. Primary end point(s): The primary endpoint of this study is the change in average pain intensity over the preceding week, rated on a visual analog scale (VAS) (from 0 = no pain to 10 = maximal pain) between D0 (baseline) and D71 (after 8 weeks of treatment with a stable dose). Pain intensity on the VAS is a validated clinical criterion for the global assessment of both discriminative and emotional aspects of pain. Secondary Objective: Evaluate :; ‐The respective effects of oxycodone and levodopa, versus placebo, on the different components of pain through various clinical pain questionnaires; ‐The response rates based on 30% and 50% in each groups; ‐The use of rescue analgesic medication (acetaminophen) in the three groups; ‐The respective effects of oxycodone and levodopa, versus placebo, on behavioral symptoms (depression, anxiety, apathy, fatigue, sleep disorders), motor symptoms and quality of life ; ‐The putative correlation between changes in motor status and variations of pain intensity; ‐ A head‐to‐head comparison of the effects of oxycodone versus levodopa on clinical pain parameters; ‐The safety and tolerability of each drug; ; The exploratory objective is to evaluate the respective effects of oxycodone and levodopa, versus placebo, on resting‐state brain network changes (3T fMRI), to identify the pathophysiological mechanisms underlying the analgesic effect of each drug.; Timepoint(s) of evaluation of this end point: Between D0 (baseline) and D71 (after 8 weeks of treatment with a stable dose). The first part assesses the causality of the link between PD and pain i.e. pain is considered to be related to PD if the patient reports at least three of the following five features: ‐ Pain is chronologically related to PD (occurring at the onset of PD or influenced by motor condition) ‐ Pain located in the half of the body most severely affected by PD (topographical relationship to PD) ‐ Pain is influenced by dopaminergic drugs ‐ Pain is not related to any other evident etiology (rheumatic, traumatic or orthopedic disorders) ‐ The patient identifies a link between pain and disease

Epistemonikos ID: 53cbd0e34e112627c122896b4a9a71ebadc01137
First added on: Aug 25, 2024