A PROSPECTIVE, MULTICENTER, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUPS, PHASE 2B/3 STUDY TO COMPARE THE EFFICACY AND SAFETY OF MASITINIB VERSUS PLACEBO IN THE TREATMENT OF PATIENTS SUFFERING FROM PROGRESSIVE SUPRANUCLEAR PALSY (PSP)

AB Science,0 个研究点目标入组 0 人开始时间: 2016年12月28日最近更新: 2023年9月4日

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•1. Female or male patient aged between 40 and 80 years old, weighing more than 41 kg and with a Body Mass Index (BMI) between 18 and 35 kg/m²
•2. Probable PSP (clinical signs of PSP) with PSP stage ≤ II defined as:
•* at least a 12-month history of postural instability or falls during the first 3 years that symptoms are present; and
•* PSPRS score  55; and
•* an akinetic-rigid syndrome with prominent axial rigidity
•3. MAPT H1 positive haplotype
•4. Modified Hachinski score ≤ 3.
•5. Score ≥ 25 on the mini-mental state examination (MMSE).
•6. Patient judged by investigator to be able to comply with neuropsychological evaluation at baseline and throughout the study.
•7. Patient able to tolerate the MRI scan during screening with either no sedation or low dose benzodiazepines.
•8. Patient with life expectancy ≥ 6 months
•9. Female patient of child bearing potential must have a negative pregnancy test at screening and baseline.
•10. Patient with adequate organ function at screening and baseline:
• absolute neutrophils count (ANC) ≥ 2.0 x 109/L,
• haemoglobin ≥ 10 g/dL
• platelets (PTL) ≥ 100 x 109/L
• AST/ALT ≤ 3x ULN
• bilirubin ≤ 1.5x ULN
• creatinine clearance ≥ 60 mL/min
• albumin > 1 x LLN
• Proteinuria < 30 mg/dL (1+) on the dipstick. If proteinuria is ≥ 1+ on the dipstick, 24 hours proteinuria must be < 1.5g/24 hours

•1. Patient with history of cardiac, hematologic, hepatic, respiratory that is clinically significant for his/her participation in the study
•2. Insufficient fluency in local language to complete neuropsychological and functional assessments
•3. Diagnosis of Amyotrophic Lateral Sclerosis or other motor neuron disease or other diagnosis of taupathies (such as corticobasal degeneration, frontotemporal lobe dementia, multiple system athrophy)
•4. Any of the following condition:
• Abrupt onset of symptoms defined in inclusion criteria 2 associated with ictal events,
• Head trauma related to onset of symptoms defined in inclusion criteria 2,
• Severe amnesia within 6 months of the symptoms defined in inclusion criteria 2,
• Cerebellar ataxia,
• Choreoathetosis,
• Early, symptomatic autonomic dysfunction; or
• Tremor while at rest.
•5. Treatment with lithium, methylene blue, tramiprosate, ketone bodies, latrepirdine, or any putative disease-modifying agent directed at tau within 90 days of screening.
•6. History of alcohol or substance abuse within 1 year prior to screening and deemed to be clinically significant by the site investigator.
•7. History of deep brain stimulator (DBS) surgery.

发起方

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