Parkinson's disease MedDRA version: 20.0 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
AB Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria 1. Men and women with idiopathic Parkinson's disease according to DSM IV criteria of more than 3 years’ duration defined by the cardinal sign, Bradykinesia, plus the presence of at least 1 of the following: resting tremor, rigidity, or impairment of postural reflexes, and without any other known or suspected cause of Parkinsonism 2. Cognitive impairment confirmed by Mini-Mental State Examination (MMSE) score = 12 and = 25 3. Modified Hoehn and Yahr stage from 2 to 4 4. Minimal duration of disease evolution of 2 years 5. Patients treated for a minimum of 2 months with a stable dose of levodopa and/or memantine and/or amantadine and/or rivastigmine at baseline, with no changes foreseen in therapy throughout the study 6. Patients with unilateral tremor at onset of the disease 7. Patient with normal organ function defined as: 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 50 kg and BMI between 18 and 35 kg/m² Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: Exclusion criteria 1. History of cardiac, hematologic, hepatic, renal, pancreatic, metabolic, respiratory, gastrointestinal, endocrinologic, or neurologic system or a tumor that is clinically significant for their participation in the study 2. Patient with a diagnosis of PD Dementia (probable, possible) according to the Clinical Diagnostic Criteria for Dementia Associated with PD, active psychosis or hallucinations, severe depression or delirium 3. Patient with a major surgery within 2 weeks prior to study entry 4. Pregnant, or nursing female patient 5. Patient presenting with cardiac disorders defined by at least one of the following conditions: • Patient with recent cardiac history (within 6 months) of: - Acute coronary syndrome - Acute heart failure (class III or IV of the NYHA classification) - Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death) • Patient with cardiac failure class III or IV of the NYHA classification • Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block) • Syncope without known aetiology within 3 months • Uncontrolled severe hypertension, according to the judgment of the investigator, or symptomatic hypertension 6. Patient presenting with one of the following conditions: • Life expectancy < 6 months • < 5 years free of malignancy, except treated basal cell skin cancer or cervical carcinoma in situ • Any severe and/or uncontrolled medical condition • Patient with an active infection (Human immunodeficiency virus infection and/or hepatitis B or C infection, tuberculosis...) 7. Patient with chronic diarrhoea, oedema, dermatologic diseases or history of cutaneous allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective is to compare the efficacy and safety of masitinib in cognitively impaired but non-demented Parkinson's disease patients Primary endpoint • ADCS-ADL score at week 48 ; Secondary Objective: Secondary endpoints • ADCS-CGIC score at week 48 • ADAS-Cog score at week 48 • NPI-10 score at week 48 • CIBIC+ score at week 48 • Mattis Dementia Rating Scale (DRS) score at week 48 • CDR scale score at week 48 • Mini-Mental State Examination (MMSE) score at week 48 • Modified Hoehn and Yahr stage at week 48 • UPDRS part I (mentation, behaviour and mood) score at week 48 • UPDRS part II (Activity Daily Living) score at week 48 • UPDRS part III (motor) score at week 48 • Parkinson's Disease Questionnaire (PDQ – 39) score at week 48 • Pharmacokinetics data at week 48 • Safety assessments: ? Adverse events ? Laboratory values, Vital signs and Physical examination findings including electrocardiograms (ECG) ; Primary end point(s): Primary endpoint • ADCS-ADL score at week 48 ;Timepoint(s) of evaluation of this end point: Week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Week 48; Secondary end point(s): Secondary endpoints • ADCS-CGIC score at week 48 • ADAS-Cog score at week 48 • NPI-10 score at week 48 • CIBIC+ score at week 48 • Mattis Dementia Rating Scale (DRS) score at week 48 • CDR scale score at week 48 • Mini-Mental State Examination (MMSE) score at week 48 • Modified Hoehn and Yahr stage at week 48 • UPDRS part I (mentation, behaviour and mood) score at week 48 • UPDRS part II (Activity Daily Living) score at week 48 • UPDRS part III (motor) score at week 48 • Parkinson's Disease Questionnaire (PDQ – 39) score at week 48 • Pharmacokinetics data at week 48 • Safety assessments: ? Adverse events ? Laboratory values, Vital signs and Physical examination findings including electrocardiograms (ECG) | — |
Countries
Bulgaria, Czech Republic, France, Germany, Hungary, Romania, Slovakia, South Africa, Spain, United States
Contacts
Public ContactAlain Moussy
AB Science
Outcome results
None listed