PER-069-06已完成未知
RANDOMIZED, DOUBLE BLIND, CONTROLLED WITH PLACEBO, OF PARALLEL GROUPS STUDY, WITH FIXED AND FLEXIBLE DOSE ARMS OF SLV308 TO EVALUATE THE EFFICACY AND SAFETY OF SLV308 AS A MONOTHERAPY IN THE TREATMENT OF PATIENTS WITH PARKINSON´S DISEASE EARLY STAGE
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
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
- 年龄范围
- 0 至 0（—）
入选标准
- •1. Subjects who give written informed consent before initiating any specific procedure of the study.
- •2. The clinical diagnosis of the subjects must meet the diagnostic criteria of idiopathic Parkinson´s disease.
- •3. Until stage 3 of the modified Hoehn and Yahr scale.
- •4. The motor score of the Unified Parkinson´s Disease Rating Scale (UPDRS) (part 3) must be a total of at least 10 in the baseline assessment.
- •5. Outpatient patients.
- •6. Subjects ≥ 30 years of age.
- •7. For antiparkinsonian medication, except SLV3P8, the following criteria will be applied: a) Subjects may have received treatment with formulations of L-dopa or dopamine agonists for a total of up to 90 days. b) Subjects must have discontinued the use of L-dopa and / or dopamine agonists for at least 90 days before the baseline evaluation. c) Effective pre-treatment can not be interrupted for the sole purpose of enrolling the subject in the study. d) Concomitant antiparkinsonian treatment other than L-dopa and dopamine agonists may be administered if the doses have been stable for at least 28 days before the baseline assessment and during the study.
- •8. Men and women; women should not have the potential to procreate, or: a) Must present a negative test for human chorionic gonadotropin B and b) Use an accepted contraceptive method.
排除标准
- •1. The diagnosis is not clear or there are suspicions of other parkinsonian syndromes.
- •2 Subjects who underwent surgery for the treatment of PD or who underwent any other brain surgery.
- •3. Presence of dyskinesias, motor fluctuations or loss of postural reflexes.
- •4. Subjects with a history of lack of response to an adequate treatment of L-dopa or a dopamine agonist.
- •5. Subjects in whom the previous treatment with dopamine agonists due to induction of psychosis and / or sleep attacks should have been discontinued.
- •6. Treatment within 60 days prior to the baseline assessment with monoamine oxidase inhibitors, alpha-methyldopa or metoclopramide, treatment within 30 days prior to baseline evaluation with parenteral ergots, methylphenidate, amphetamine, beta-blockers to treat tremors, isoprenaline , adrenaline, dopamine, dobutamine, reserpine, flunarizine or cinnarizine.
- •7. Current diagnosis or history of drug or alcohol abuse within 12 months prior to Visit 1.
- •8. Current primary psychiatric diagnosis of acute psychotic disorder or other primary psychiatric diagnoses.
- •9. Subjects that are considered to be violent or subjects considered to be suicidal.
- •10. Other psychiatric, neurological or behavioral disorders that may interfere with the conduct or interpretation of the study.
- •11. History of hallucinations, psychosis and / or treatment with antipsychotics within one year prior to the baseline evaluation.
- •12 History or presence of seizure disorders and subjects that require treatment with anticonvulsants.
- •13. Subjects with symptomatic brain disease focal neurological lesions or any acute brain trauma that requires treatment with anticonvulsant therapy.
- •14. Clinically significant abnormal laboratory data, at Visit 1, or any abnormal laboratory values that could interfere with the evaluation of safety or efficacy.
- •15. Current evidence of a hematological, autoimmune, endocrine, cardiovascular, renal or gastrointestinal disorder that is clinically significant.
- •16. Subjects whose current medication regimen or condition suggests they will not remain constant during the study participation.
- •17. Known unstable insulin-dependent diabetes mellitus or an oral antihyperglycemic agent for less than 28 days before the baseline evaluation.
- •18. Any malignant disease or a history of neoplasia, except in situ carcinoma of the cervix or basal cell carcinoma of the skin.
- •19. History of gastrointestinal, hepatic, renal or other known condition that could interfere with the absorption, distribution, metabolism or excretion of the medication and / or the study evaluations.
- •20. Clinically relevant ischemic heart symptoms or history of myocardial infarction, coronary artery bypass surgery or percutaneous transluminal coronary angioplasty.
- •21. Subjects with unstable hypertension or symptomatic hypotension or orthostatic hypotension. In addition, subjects with a history of repeated vasovagal syncope should also be excluded.
- •22. Subjects should be excluded when vital signs show abnormal values that are considered clinically significant in the selection.
- •23. Subjects with evidences in the ECG of: a) Fibrillation / atrial flutter. b) Prolonged QTc. c) Complex premature ventricular contractions. d) Clinically relevant conduction disorders.
- •24. Hypersensitivity or known contraindication to the use of serotonergic agents or dopamine agonists.
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