EUCTR2020-001175-32-PL进行中（未招募）1 期
Randomised, double-blind, placebo-controlled, clinical study to evaluate the effect of opicapone 50 mg on Parkinson’s disease patients with end-of-dose motor fluctuations and associated pain. - OpiCapone Effect on motor fluctuations and pAiN (OCEAN)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 176
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •At Visit 1 (Screening), patients must meet ALL of the following criteria:
- •1. Able to comprehend and willing to sign an informed consent form and to comply with all
- •aspects of the study.
- •2. Male or female patients aged 30 years or older.
- •3. Experiencing PD associated pain for at least 4 weeks prior to V1.
- •4. Diagnosed with idiopathic PD according to the UK Parkinson’s Disease Society Brain
- •Bank Clinical Diagnostic Criteria (2006) or according to MDS Clinical Diagnostic Criteria
- •5. Disease severity Stages I-III (modified Hoehn & Yahr staging) at ON.
- •6. Treated with 3 to 8 intakes per day of L-dopa/DDCI (which may include a slow-release
- •formulation), on a stable regimen for at least 4 weeks before V1.
- •7. In case of any other anti-PD-treatment, it should be on a stable regimen for at least 4 weeks
- •before V1, and not likely to need any adjustment until V6.
- •8. No changes in chronic treatment regimen for pain within the last 4 weeks before V1. This
- •includes medication (including but not limited to paracetamol, opioids, nonsteroidal anti-inflammatory drugs [NSAIDS], antidepressants, anticonvulsants and corticosteroids) and
- •non-medication therapies (including but not limited to transcutaneous electrical nerve
- •stimulation and bioelectrical therapy).
- •9. Signs of wearing-off” phenomenon (end-of-dose motor fluctuations) with average total
- •daily OFF time while awake of at least 1.5 hours, excluding the early morning pre-first
- •dose OFF, despite optimal anti-PD therapy (based on investigator’s assessment).
- •10. Domain 3 of KPPS = 12.
- •11. For females: Postmenopausal for at least 2 years before V1, surgically sterile for at least
- •6 months before V1, or practicing effective contraception until V6. Female patients who
- •request to continue with oral contraceptives must be willing to use non-hormonal methods
- •of contraception in addition during the course of this study.
- •For males: Male patients who are sexually active with a partner of childbearing potential
- •must use, with their partner, a condom plus an approved method of highly effective
- •contraception during the treatment period until V6.
- •At Visit 2b (Baseline), patients must meet ALL of the following criteria:
- •12. Have filled-in self-rating diary in accordance with the diary instructions and with = 3
- •missing entries per day, in the 3 days preceding V2a/V2b.
- •13. With at least 1.5 OFF hours per day, excluding the early morning pre-first dose OFF period
- •(i.e. the time between wake-up and response to the first L-dopa/DDCI dosage), as recorded
- •in at least 2 of the 3 days in the self-rating diary for the 3 days preceding V2a/V2b.
- •14. Results of the screening laboratory tests are considered acceptable by the investigator (i.e.
- •not clinically relevant for the well-being of the patient or for the purpose of the study).
- •15. Domain 3 of KPPS = 12.
- •16. Adequate compliance to relevant (PD and pain related) concomitant medication during the
- •screening period (based on the investigator’s judgment).
- •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 88
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 88
排除标准
- •1. Non-idiopathic PD (atypical parkinsonism, secondary [acquired or symptomatic]
- •parkinsonism, Parkinson-plus syndrome).
- •2. Severe and/or unpredictable OFF periods, according to investigator judgement.
- •3. Major/prominent non-PD-related pain (e.g. due to malignant disease).
- •4. Treatment with prohibited medication: entacapone, tolcapone, monoamine oxidase (MAO)
- •inhibitors (except selegiline up to 10 mg/day in oral formulation or 1.25 mg/day in buccal
- •absorption formulation, rasagiline up to 1 mg/day or safinamide up to 100 mg/day), or
- •antiemetics with antidopaminergic action (except domperidone) within the last 4 weeks
- •before V1.
- •5. Previous or planned (during the entire study duration) L-dopa/carbidopa intestinal gel
- •infusion, brain stimulation or stereotactic surgery (e.g. pallidotomy, thalamotomy).
- •6. Treatment with apomorphine within the last 4 weeks before V1 or likely to be needed at
- •any time until V6.
- •7. Previous or current use of opicapone.
- •8. Use of any other IP, currently or within the 3 months (or within 5 half-lives of the IP,
- •whichever is longer) before V1.
- •9. Past (within the past year) or present history of suicidal ideation or suicide attempts.
- •10. Current or previous (within the past year) alcohol or substance abuse excluding caffeine or
- •11. Phaeochromocytoma, paraganglioma, or other catecholamine secreting neoplasms.
- •12. Known hypersensitivity to the excipients of IP (including lactose intolerance, galactose
- •intolerance, Lapp lactase deficiency or glucose-galactose malabsorption) or of rescue
- •medication.
- •13. History of neuroleptic malignant syndrome or non-traumatic rhabdomyolysis.
- •14. History of severe hepatic impairment (Child-Pugh Class C).
- •15. Previous history of psychosis or psychiatric disorders, including severe major depression.
- •16. Any medical condition that might place the patient at increased risk or interfere with
- •assessments.
- •17. For females: Pregnant or breastfeeding.
- •18. Employees of the investigator, study centre, sponsor, clinical research organisation and
- •study consultants, when employees are directly involved in this study or other studies under
- •the direction of this investigator or study centre, and their family members.
- •19. Persons committed to an institution by virtue of an order issued either by the judicial or
- •other authorities.
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