Clinical study for the evaluation of the safety and efficacy of masitinib in patients suffering from parkinson's disease

Phase 1

Active, not recruiting

• Conditions: Parkinson's disease; MedDRA version: 20.0 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2010-024424-26-SK
• Lead Sponsor: AB Science

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-28
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 45

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 < 30 mg/dL (1+) on the dipstick. If proteinuria is = 1+ on the dipstick, 24 hours proteinuria must be < 1.5g/24 hours
8.Male or female patient, aged = 40 years, weight > 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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified