Effect of Safinamide on Parkinson's Disease Related Chronic Pain
Condition: Idiopathic Parkinson Disease
MeSH terms: Parkinson Disease; Chronic Pain
Intervention: Safinamide Methanesulfonate; Safinamide methanesulfonate matching placebo
Intervention description: 50 mg, 100 mg; 50 mg, 100 mg
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 94.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Parkinson disease; Safinamide

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
    

Eligibility criteria:

        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 failure using the Child-Pugh classification score.

          9. History of drug and/or alcohol abuse within 12 months prior to screening as defined by
             the current edition of the Diagnostic and Statistical Manual of Mental Disorders.

         10. Allergy/sensitivity, intolerance or contraindications to Safinamide.

         11. Treatment with monoamine oxidase inhibitors (MAOIs), levodopa infusion, pethidine,
             fluoxetine, fluvoxamine less than 4 weeks prior to the randomisation visit

         12. Use of any investigational drug or device within 30 days prior to screening or 5
             half-lives, whichever is the longest

         13. Previous treatment with Safinamide in the 9 months before the screening visit

         14. Mini-Mental State Exam (MMSE) total score <24 at screening.

         15. NRS score ≤ 4 points at randomization visit.

         16. Any clinically significant condition which, in the opinion of the Investigator, would
             not be compatible with study participation or represent a risk for participants while
             in the study