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, France, Germany94 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 range
30 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
. 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.