EUCTR2016-001403-23-FI进行中（未招募）1 期
An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
入选标准
- •1. Male or female subjects of at least 30 years old at the time of Visit 3.
- •2. Subject must have a diagnosis of idiopathic Parkinson's disease according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria
- •3. Patients with advanced levodopa-responsive Parkinson's disease and persistent motor fluctuations who have not been controlled with optimized medical treatment. Optimized medical treatment is defined as the maximum therapeutic effect obtained with pharmacological antiparkinsonian therapies when no further improvement is expected regardless of any additional manipulations of levodopa and/or other antiparkinsonian medication. This will be based on the Investigator's clinical judgment.
- •4. UDysRS Total score = 30 at Visit 3 based on Central Blinded Rater's score.
- •5. Subject (or subject's proxy/caregiver) must be able to complete both the Subject Dosing Diary and the PD Diary and must be able to demonstrate the ability to operate, manipulate, and care for the pump and tubing.
- •6. Subject must demonstrate at least 75% concordance with the Investigator's or qualified designee's assessment of symptoms on the Parkinson's Disease Diary following training at Screening Visit 1 with concordance on at least 1 time interval of Off, concordance on at least 1 time interval of ON regardless of dyskinesia and at least 1 time interval of ON with dyskinesia irrespective of whether the dyskinesia are troublesome or not troublesome.
- •7. Subject is eligible to transfer to commercial treatment of Duodopa after completing the study based on local country requirements.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Predominantly di-phasic dyskinesia, as per Investigator discretion.
- •2. Patients who were treated with LCIG before
- •3. Patients who have had previous surgery for PD including, but not limited to deep brain stimulation (DBS) or cell transplantation.
- •4. A Mini-Mental State Examination (MMSE) score of < 24 at Visit 1 or significant cognitive impairment that, in the opinion of the Investigator, could impact the subject's ability to participate in the trial
- •5. Current primary psychiatric diagnosis of uncontrolled acute psychotic disorder or primary psychiatric diagnoses of bipolar disorder, schizophrenia, obsessive compulsive disorder or currently experiencing a major depressive episode with psychotic features per Diagnostic and Statistical Manual of Mental Disorders Fifth Edition, Text Revision (DSM V-TR).
- •6. Subject experiencing clinically significant sleep attacks or clinically significant impulsive behavior (e.g., pathological gambling, hypersexuality) at any point during the three months prior to the Screening evaluation as judged by the Investigator.
- •7. Current diagnosis or history of drug or alcohol abuse (DSM-V-TR criteria) within 12 months prior to screening visit.
- •8. Participation in a concurrent interventional or observational study.
- •9. Lack of motivation or insufficient language skills to complete the study questionnaires.
- •10. Subject's PD diagnosis is unclear or there is a suspicion that the subject has a parkinsonian syndrome such as secondary parkinsonism (e.g., caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), atypical Parkinson Syndrome (e.g., Multiple System Atrophy, Progressive supranuclear Palsy, Diffuse Lewy Body disease) or other neurodegenerative disease that might mimic the symptoms of PD.
研究者
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