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Effect of Safinamide on Parkinson's Disease Related Chronic Pain

CompletedPhase 4NCT03841604
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

Primary objective: • To evaluate the potential efficacy of safinamide 100 mg once daily (OD), compared with placebo, as add-on therapy for PD-related chronic pain Secondary objectives: * Percentage of pain responders * Clinical Global Impression for pain * Patient Global Impression for pain * Reduction in use of pain drugs * Mood * Motor and non-motor symptoms Safety Objectives: • Safety and tolerability

Study details

Official title
A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide 100mg Once Daily, as add-on Therapy, in Idiopathic Parkinson's Disease (PD) Patients With Motor Fluctuations and PD Related Chronic Pain
Conditions
  • Idiopathic Parkinson Disease
Interventions
  • Drug: Safinamide Methanesulfonate
  • Other: Safinamide methanesulfonate matching placebo
Sponsor
Zambon SpA
Start date
2019-04-09
Primary completion
2021-04-30
Sex
All
Age range
from 30 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
Austria, France, Germany, Italy, Spain
Total sites listed
45

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Participant must be 30 years of age or older, at the time of signing the informed consent. 2. Diagnosed with IPD by using the United Kingdom Parkinson's Disease Society Brain Bank criteria for more than 5 years duration. 3. Receiving treatment with a stable dose of oral L-Dopa (including controlled release \[CR\], immediate release \[IR\] or a combination of CR/IR), with and without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor and may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine for at least 4 weeks prior to the randomisation (baseline visit). 4. Hoehn and Yahr stage between 2-3 (inclusive) during the "ON" phase at the screening visit. 5. Experiencing motor fluctuations following optimum titration of treatment medications and within the 4 weeks immediately prior to randomisation. 6. Experiencing chronic pain (i.e. ongoing for ≥3 months prior to screening visit); the Investigator must consider chronic pain directly related to PD and not explained by any other health problem (e.g. peripheral neuropathy, organ disease or arthritis pain) OR consider the intensity of chronic pain specifically aggravated by PD. 7. If taking regular analgesics, the treatment regimen should be stable in the 4 weeks prior to the randomisation visit. 8. Able to maintain an accurate and complete electronic diary with the help of a caregiver. 9. Male or female •A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: i.Not a woman of childbearing potential (WOCBP) OR ii.A WOCBP who agrees to follow the contraceptive guidance 10. Capable of giving signed informed consent Exclusion Criteria: 1. Any form of Parkinsonism other than IPD. 2. Diagnosis of chronic migraine (\>15 days per month) or cancer pain. 3. History of bipolar disorder, depression, schizophrenia or other psychotic disorder requiring treatment with neuroleptics. 4. History of dementia or cognitive dysfunction. 5. Severe, peak dose or biphasic dyskinesia. 6. Unpredictable or widely swinging fluctuations. 7. Ophthalmologic history including any of the following conditions: albinism, uveitis, retinitis pigmentosa, retinal degeneration, active retinopathy, severe progressive diabetic retinopathy, inherited retinopathy or family history of hereditary retinal disease. 8. Moderate or severe liver fai…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03841604