EUCTR2020-001175-32-GB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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion criteria at Visit 1 (Screening):
- •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 screening.
- •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 (2015).
- •5. Disease severity Stages I-III (modified Hoehn & Yahr staging) at ON.
- •6. Treated with 3 to 7 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.
- •Inclusion Criteria at V2b (Baseline):
- •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: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 176
- •F.1.3 Elderly (>=65 years) yes
- 另有 1 项未显示
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, deep 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
- •10. Current or previous (within the past year) alcohol or substance abuse
- •excluding caffeine or nicotine.
- •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.
研究者
相似试验
进行中（未招募）
1 期
Clinical study to investigate if Opicapone 50mg can reduce pain associated to Parkinson’s diseaseEUCTR2020-001175-32-PTBial - Portela & Ca, S.A.176
进行中（未招募）
1 期
Clinical study to investigate if Opicapone 50mg can reduce pain associated to Parkinson’s diseaseParkinson's disease patients with wearing-off motor fluctuations and associated pain.MedDRA version: 20.0Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disordersEUCTR2020-001175-32-CZBial - Portela & Ca, S.A.176
进行中（未招募）
1 期
Clinical study to investigate if Opicapone 50mg can reduce pain associated to Parkinson’s diseaseParkinson's disease patients with wearing-off motor fluctuations and associated pain.MedDRA version: 20.0Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disordersEUCTR2020-001175-32-PLBial - Portela & Ca, S.A.176
已完成
1 期
Randomized, double-blind, placebo-controlled, clinical trial with OSD-001 for skin lesions due to tuberous sclerosis complex.JPRN-UMIN000012420Department of Dermatology Graduate School of Medicine, Osaka University36
进行中（未招募）
1 期
Clinical study to investigate if Opicapone 50mg can reduce pain associated to Parkinson's diseaseParkinson's disease patients with wearing-off motor fluctuations and associated pain.MedDRA version: 20.0Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disordersEUCTR2020-001175-32-ITBIAL-Portela & Ca, S.A.176