ISRCTN55858075已完成未知
A randomised, double-blind, placebo-controlled, dose-escalation study of multiple doses of BIIB014 administered orally in subjects with early Parkinson's disease
Biogen Idec Ltd (USA)0 个研究点目标入组 40 人开始时间: 2007年8月30日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 40
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
- 性别
- All
入选标准
- •1. Must give written informed consent and any authorisations required by local law
- •2. Must be 30 years or older at the time of informed consent
- •3. Must carry a diagnosis of idiopathic Parkinson?s disease, without any other known or suspected cause of parkinsonism, according to the UK Parkinson?s Disease Society Brain Bank Clinical Diagnostic Criteria. Initial diagnosis of PD must have been made within the 5 years prior to Screening with at least two or more of the following cardinal signs being present: bradykinesia, resting tremor, rigidity, and postural instability.
- •4. Must be Modified Hoehn and Yahr Stage 1 to 2.5 inclusive
- •5. Must have a Unified Parkinson's Disease Rating Scale (UPDRS) motor score (Part III) of greater or equal to 10
- •6. For subjects receiving an anticholinergic agent and/or MAO-B inhibitor, must have been on a stable dose of that medication for at least 4 weeks prior to Day 1. Subjects must be willing and able to maintain this dosing regimen throughout their participation in the study and must be willing and able to refrain from any other PD medication throughout their participation in the study.
- •7. Male and female subjects of child-bearing potential must be willing to practice effective birth control for the duration of the study. Female subjects must be one of the following:
- •7.1. Postmenopausal for at least 12 months, as confirmed by the patient's Obstetrician/Gynecologist (OB/GYN) or medical records
- •7.2. Surgically sterile (i.e., no uterus or no ovaries; females who have tubal ligation [tubes tied or cut] are not considered surgically sterile)
- •7.3. Willing to use 2 acceptable forms of birth control (i.e., barrier and spermicide, intrauterine device and barrier or spermicide, or birth control pill and barrier or spermicide). Male subjects with partners of child-bearing potential must use barrier contraception in addition to a second method of contraception used by their female partners. Male subjects should be advised to abstain from sexual intercourse with pregnant women or use condoms. Male and female subjects must be willing and able to continue contraception for 2 months after their last dose of study treatment. Female subjects of childbearing potential must have a negative pregnancy test result at both the Screening Visit and the Day 1 Visit.
排除标准
- •1. Has a Mini Mental State Examination (MMSE) score less than 26 (the MMSE is provided in the Study Reference Manual)
- •2. History or clinical features (such as impaired downward gaze, prominent axial rigidity, gait initiation failure, autonomic dysfunction, etc.) consistent with an atypical parkinsonian syndrome
- •3. Any significant non-PD central nervous system disorder, including history of cerebrovascular disease, epilepsy, mass brain lesion, chronic inflammatory brain disease, or other neurological condition
- •4. Any significant AXIS I psychiatric disease as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition-Revised (DSM IV-TR, American Psychiatric Association, 2000)
- •5. History of cognitive (e.g., cognitive slowing, bradyphrenia) or neuropsychiatric conditions.
- •6. History of surgical intervention for PD (pallidotomy, thalamotomy, deep brain stimulation, etc.)
- •7. History of L-DOPA-induced motor or non-motor complication
- •8. History of malignancy
- •9. History of severe allergic or anaphylactic reactions to any drug
- •10. History of human immunodeficiency virus (HIV)
- •11. Positive for hepatitis C antibody and/or positive for hepatitis B surface antigen (HBsAg)
- •12. Serious infection (e.g., pneumonia, septicaemia) within 4 weeks prior to Day 1
- •13. Clinically significant renal dysfunction (serum creatinine greater than 2.0 mg/dL [greater than 178 mmol/L])
- •14. Abnormal laboratory results as follows:
- •14.1. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, gamma-glutamyl transferase (GGT) levels greater than 1.5 x upper limit of normal (ULN)
- •14.2. Serum lipase greater than ULN
- •14.3. White blood cell count (WBC) less than 4,000 cells/mm^3
- •14.4. Haemoglobin less than 10 g/dL, or any other abnormal laboratory value that could interfere with the assessment of safety
- •15. HbA1c greater than 7.0%
- •16. A positive G6PD assay. Subjects with a family history of G6PD (including immediate family members [first degree relatives] diagnosed with sickle cell anaemia or deaths due to neonatal jaundice) and subjects with a history of haemolytic anaemia or severe hemolysis are also to be excluded from the study.
- •17. Clinically significant (as determine by the Investigator) electrocardiogram (ECG) (12-lead) abnormalities including QTc interval greater than 500 Msec for males and greater than 450 Msec for females
- •18. Supine (measured at least 5 minutes after resting) or standing (measured 2 minutes after changing from a supine to a standing position) blood pressure (BP) of greater than 140 or less than 90 mmHg systolic or greater than 90 or less than 40 mmHg diastolic on two consecutive occasions at least 15 minutes apart
- •19. Orthostatic hypotension as defined by a decrease in systolic BP of greater than 20 mmHg or in diastolic BP of greater than 10 mmHg measured 2 minutes after changing from a supine to standing position (the mean of three independent sets of vital signs, taken at least 15 minutes apart at the screening visit, will determine eligibility)
- •20. Clinically significant hypertension, cardiac, gastrointestinal, renal, pulmo
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