Effect of Safinamide on Parkinson's Disease Related Chronic Pain (NCT03841604) | Clinical Trial Compass
CompletedPhase 4
Effect of Safinamide on Parkinson's Disease Related Chronic Pain
Austria, France94 participantsStarted 2019-04-09
Plain-language summary
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
Who can participate
Age range30 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Participant must be 30 years of age or older, at the time of signing the informed consent.
✓. Diagnosed with IPD by using the United Kingdom Parkinson's Disease Society Brain Bank criteria for more than 5 years duration.
✓. 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).
✓. Hoehn and Yahr stage between 2-3 (inclusive) during the "ON" phase at the screening visit.
✓. Experiencing motor fluctuations following optimum titration of treatment medications and within the 4 weeks immediately prior to randomisation.
✓. 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.
✓. If taking regular analgesics, the treatment regimen should be stable in the 4 weeks prior to the randomisation visit.
✓. Able to maintain an accurate and complete electronic diary with the help of a caregiver.
Exclusion criteria
✕. Any form of Parkinsonism other than IPD.
What they're measuring
1
Change From Baseline to Week 16 in Pain Severity (NRS-11 Scale) - Full Analysis Set
Timeframe: Baseline and Week 16
2
Change From Baseline to Week 16 in Pain Severity (NRS-11 Scale) - Per Protocol Set
✕. Diagnosis of chronic migraine (\>15 days per month) or cancer pain.
✕. History of bipolar disorder, depression, schizophrenia or other psychotic disorder requiring treatment with neuroleptics.
✕. History of dementia or cognitive dysfunction.
✕. Severe, peak dose or biphasic dyskinesia.
✕. Unpredictable or widely swinging fluctuations.
✕. 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.
✕. Moderate or severe liver failure using the Child-Pugh classification score.