EUCTR2014-003739-20-DE进行中（未招募）1 期
Open-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa-Induced Dyskinesia
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 223
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
- •Group 1: Current Adamas LID study subjects
- •Below are the inclusion criteria subjects who are continuing directly into ADS-AMT-PD302 without a time gap between their Adamas LID efficacy study and ADS-AMT-PD302:
- •1. Signed a current IRB/REB/IEC-approved informed consent form
- •2. Completed study visits per protocol in a previous Adamas efficacy study
- •3. Ambulatory or ambulatory-aided (e.g. walker or cane) ability while ON, such that the subject can complete study assessments
- •4. Knowledgeable and reliable caregiver/study partner, if appropriate, to accompany the subject to study visits and assist in completion of study assessments, as needed and allowed
- •5. History of peak dose dyskinesia that might benefit from specific dyskinesia treatment in the judgment of the subject and clinical investigator
- •6. On a stable regimen of antiparkinson’s medications, including a levodopa preparation administered not less than three times daily
- •Group 2: Previous Adamas LID study subjects
- •Below are the inclusion criteria for subjects who participated in a previous Adamas efficacy study evaluating ADS-5102 in LID and will enter ADS-AMT-PD302 with a time gap:
- •1. Signed a current IRB/REB/IEC-approved informed consent form
- •2. Completed study visits per protocol in a previous Adamas efficacy study
- •3. Ambulatory or ambulatory-aided (e.g. walker or cane) ability while ON, such that the subject can complete study assessments
- •4. Knowledgeable and reliable caregiver/study partner, if appropriate, to accompany the subject to study visits and assist in completion of study instruments, as needed and allowed
- •5. Peak dose dyskinesia during Screening that might benefit from specific dyskinesia treatment in the judgment of the subject and clinical investigator OR a history of peak dose dyskinesia that is currently being managed by amantadine treatment
- •6. On a stable regimen of antiparkinson’s medications at least 30 days prior to screening, including a levodopa preparation administered not less than three times daily
- •7. Parkinson’s disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria
- •Group 3: Non Adamas LID study subjects – with prior DBS
- •Below are the eligibility criteria for subjects who would have been deemed ineligible for participation in previous or current Adamas efficacy studies due to having undergone deep brain stimulation:
- •1. Signed a current IRB/REB/IEC-approved informed consent form
- •2. Male or female subjects between 30 and 85 years of age, inclusive
- •3. Subject has undergone deep brain stimulation procedure prior to start of this study (14 July 2014)
- •4. Ambulatory or ambulatory-aided (e.g. walker or cane) ability while ON, such that the subject can complete study assessments
- •5. Knowledgeable and reliable caregiver/study partner, if appropriate, to accompany the subject to study visits and assist in completion of study instruments, as needed and allowed
- •6. Peak dose dyskinesia during Screening that might benefit from specific dyskinesia treatment in the judgment of the subject and clinical investigator OR a history of peak dose dysk
排除标准
- •Group 1 Current Adamas subjects
- •Discontinued due to ADS-5102-AEs
- •H&Y Stage 5
- •Presence of orthostatic hypotension
- •GFR < 50 mL/min/1.73m2
- •Female is pregnant or lactating
- •Sexually active female, not sterile or 2 y postmenopausal, or will not use highly effective hormonal contraception, with a barrier, from screening to least 4 weeks post-treatment
- •Possible treatment with restricted medication
- •Planned participation in another trial
- •Group 2 Previous Adamas subjects
- •Discontinued due to ADS-5102-AEs
- •History of neurosurgery related to PD, Except DBS
- •History of other neurological disease that would affect motor function or cognition
- •Current sensory impairments impairing assessment completion or untreated angle closure glaucoma
- •History of alcohol or substance dependence or abuse seizures, stroke or TIA since completion in previous Adamas trial
- •History of MI, or NYHA Functional Classification of Heart Failure Class 3 or 4 since completion of participation in previous Adamas trial
- •Any clinically significant ECG other than isolated PVCs or first degree AV block
- •History of cancer since completion in previous Adamas trial
- •MMSE<24 during screening
- •H&Y Stage 5
- •Presence of an acute or chronic major psychiatric disorder or symptom (e.g. suicidal ideation) that would affect ability to complete assessments
- •Presence of orthostatic hypotension
- •Any of the following results at screening:
- •Hb<10g/dL
- •WBC<3.0x1e9/L
- •Neutrophils<1.5x1e9/L
- •Lymphocytes<0.5x1e9/L
- •Platelets<100x1e9/L
- •AST &/or ALT>2 ULN
- •GFR<50mL/min/1.73m2
- •Can’t swallow oral capsules or GI malabsorption
- •Female is pregnant or lactating
- •Sexually active female, not sterile or 2 y postmenopausal, or will not use highly effective hormonal contraception, with a barrier, from screening to least 4 weeks post-treatment
- •Inability to tolerate amantadine or history of suicidal ideation or suicide attempt during prior amantadine use
- •History of hypersensitivity or allergic reaction to amantadine, rimantidine, or memantine, or to any of the excipients used in the study medication
- •Received live attenuated influenza vaccine within 2 weeks prior to enrolment
- •Current treatment with carbonic anhydrase inhibitors, sodium bicarbonate, or urinary acidification agents, quinine, quinidine, triamterene, or trimethoprim
- •Current treatment with medications that act primarily by blocking dopamine receptors & current treatment with medications that prolong the QT interval & known risk of torsades de pointes
- •Treatment with an investigational drug (other than ADS-5102) within 30 days prior to screening
- •Treatment with an investigational biologic 6 m to screening
- •Possible treatment with restricted medication
- •Current/planned participation in another trial
- •Group 3 Non Adamas Subjects – with prior DBS
- •History of neurosurgery related to PD, excep
研究者
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