EUCTR2011-001092-39-IT进行中（未招募）不适用
A multi-centre, randomized, double-blind, placebo-controlled, parallelgroup, multiple oral dose study to assess the efficacy, safety and tolerability of AQW051 in reducing L-dopa induced dyskinesias in Parkinson's patients with moderate to severe L-dopa induced dyskinesias
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 72
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. Male and female, non-smoking patients between 30 and 85 years of age (both inclusive). 2. Written informed consent must be obtained before any assessment is XML File Identifier: VXYjImYpNkc8H5t03PaNfKGLF34= Page 14/27 performed. 3. Patients with idiopathic Parkinson's disease diagnosed by UK Parkinson's disease Society Brain Bank criteria. 4. Patients with L-dopa induced dyskinesia greater than 20% (UPDRS item of 32, rating =1) of moderate to severe (complete disabling) intensity (UPDRS item 33 rating = 2). 5. Patients with dyskinesias for at least 3 months before randomization. 6. Patients have to be on L-dopa treatment for at least 3 years prior to randomization and the L-dopa treatment has to be stable for at least 1 month prior to randomization (i.e. the total daily dose and dosing regimen can vary among patients but has to be the stable for individual patients). Other concomitant anti-parkinsonian medication (e.g. pramipexole, cabergoline, ropinirole) is allowed but the total daily dose and dosing regimen has to be stable for at least one month prior to randomization. 7. Patients treated with amantadine, antidepressants, and/or benzodiazepines are allowed to enter the study provided that they are on a stable regimen for at least 4 weeks prior to randomization. 8. Other than related to Parkinson's disease, patients must be in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and routine laboratory tests (hematology, biochemistry, urinalysis) at screening and baseline 9. Patients must weigh at least 45 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 32 kg/m2. See Appendix 3 of this protocol for BMI ranges. 10. Able to communicate well with the investigator, to understand and comply with the requirements of the study.
- •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 36
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 36
排除标准
- •Parkinson's disease related: 1. Patients with a prior surgery for Parkinson's disease (e.g. pallidotomy). 2. Patients with a Hoehn and Yahr score of 5 when 'off'. 3. Patients with atypical Parkinson's disease (Progressive Supranuclear Palsy (PSP), Multi Systemic Atrophy (MSA). 4. Patients who are under deep brain stimulation. 5. Patients with cognitive impairment (MMSE score of less than 24). 6. Patients with a presence of psychosis, confusional states and/or repeated hallucinations. 7. Patients who participated in an anti-dyskinetic clinical study in which drugs were administered within 3 months prior to randomization, or longer if required by local regulations, and any other limit on participation based on local regulations. 8. Patients who received neuroleptics or antipsychotics during 2 months before randomization. General: 9. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 halflives of enrollment, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations. 10. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. 11. History of seizures. 12. Patients using (or have used within 5 half-lives prior to first treatment with AQW051) concomitant medication that are strong inhibitors of CYP3A4 and CYP1A2 13. A history or presence of clinically significant ECG abnormalities at Screening or Baseline. 14. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. 15. Pregnant or nursing (lactating) women. 16. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use effective contraception during the study. Please see protocol for further details. 17. Smokers (use of tobacco products in the previous 3 months). Urine cotinine levels will be measured during screening and at baseline for all subjects. Smokers will be defined as any subject who reports tobacco use and/or who has a urine cotinine = 500 ng/mL. 18. Donation or loss of 400 ml or more of blood within eight (8) weeks prior to initial dosing, or longer if required by local regulation. 19. Significant illness within two (2) weeks prior to initial dosing. 20. Recent (within the last three [3] years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc). 21. Recent (within the last three [3] years) and/or recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated). 22. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study. The Investigator should make this determination in consideration of the subject's medical history and/or clinical or laboratory evidence. 23. History or presence of impaired renal function as indicated by clinically significantly abnormal creatinine or BUN and/or urea values, or abnormal urinary constituents (e.g., albuminuria). 24. Evidence of urinary obstruction or difficulty in voiding at screening. 25. History of immunodeficiency di
研究者
相似试验
进行中（未招募）
不适用
A multi-centre, randomized, double-blind, placebo-controlled, parallel-group study in obese subjects investigating weight loss after repeated, subcutaneous doses of TM30338ObesityEUCTR2007-000993-22-SE7TM Pharma A/S
进行中（未招募）
不适用
The aim of the study is to evaluate the clinical response and the remission in subjects with moderate to severe Crohn’s disease following 8 weeks of treatment with OKZ relative to placeboModerate to severe Crohn’s diseaseMedDRA version: 14.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 14.1Level: LLTClassification code 10011403Term: Crohn's disease aggravatedSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2011-002517-11-CZCB BIOSCIENCES GmbH96
进行中（未招募）
不适用
efficacy, safety and tolerability of AQW051 in reducing L-dopa induced dyskinesias in Parkinson’s patients with moderate to severe L-dopa induced dyskinesiasEUCTR2011-001092-39-DEovartis Pharma Services AG72
进行中（未招募）
不适用
Efficacy, Safety and Tolerability of AFQ056 in Patients with Huntington's Disease in Reducing ChoreaHuntington's diseaseMedDRA version: 13.1Level: LLTClassification code 10020469Term: Huntington's choreaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2009-011743-39-DEovartis Pharma Services AG60
进行中（未招募）
1 期
A multi-centre, randomized, double-blind, placebo-controlled, dose range finding study to identify the optimal (i.e. safe and effective) dose of PURETHAL® Mites SCIT in patients with house dust mites-induced persistent allergic rhinitis/rhinoconjunctivitis. - PURETHAL® Mites Dose Range Finding study in patients with persistent allergic rhinitis/rhinoconjunctPersistent allergic rhinitis or rhinoconjunctivitis with or without concomitant mild to moderate asthma induced by house dust mite (HDM) allergy (or sensitization).MedDRA version: 14.1Level: SOCClassification code 10021428Term: Immune system disordersSystem Organ Class: 10021428 - Immune system disordersEUCTR2011-000393-61-NLHAL Allergy B.V.290