EUCTR2017-002426-20-AT进行中（未招募）1 期
A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinamide 100 mg once daily, as add-on therapy, in idiopathic Parkinson’s Disease (IPD) patients with motor fluctuations and PD related chronic pain - Pain study
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Zambon SpA
- 入组人数
- 105
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 participants: A female participant is eligible to participate if
- •she is not pregnant (see Appendix 4), not breastfeeding, and at least one
- •of the following conditions applies:
- •i. Not a woman of childbearing potential (WOCBP) as defined in
- •ii. A WOCBP who agrees to follow the contraceptive guidance in
- •Appendix 4.
- •10. Capable of giving signed informed consent as described in Appendix
- •1 which includes compliance with the requirements and restrictions
- •listed in the informed consent form (ICF) and in this protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 59
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 46
排除标准
- •Participants are excluded from the study if any of the following 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
- •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.
- •Prior/Concomitant Therapy
- •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.
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