Evaluation of the effect of 6 months treatment with DC158AM on fatigue in patients with Parkinson’s disease. Multicentre, randomised, double-blind, placebo-controlled study in parallel groups.

PIERRE FABRE MEDICAMENT0 个研究点目标入组 120 人开始时间: 2007年12月7日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•Male or female between 45 and 80 years of age with :
•- an idiopathic Parkinson’s disease lasting for more than 3 years, characterized by 2 of the following 3 cardinal signs (signs need to be asymmetric): resting tremor, bradykinesia and rigidity.
•- a good response to levo-dopa as perceived by the patient (more than 50%),
•- using pharmacological therapies and / or deep brain stimulation (DBS) by electrodes,
•- a mean score greater than 4 on the Fatigue Severity Scale,
•- normal or sufficiently preserved daily activities in order to exclude the diagnosis of dementia,
•MMSE score greater than or equal to 26,
•Mastering the French language
•Having given his/her written consent to take part in the study,
•Patients covered by a social security or health insurance system.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- patient with a cerebrovascular disease and a Hachinski score > 4,
•- patient with a progressive and/or poorly balanced psychiatric disorder according to DSM-IV, particularly: ongoing major depressive episode or recurrent depression, or bipolar disorders according to DSM-IV,
•- patient with the following neurological disorders:
•* Signs or symptoms suggesting other parkinsonian syndromes,
•* History of seizure disorder or epilepsy,
•* cerebral infarction during the 12 months prior to inclusion,
•* dementia irrespective of cause,
•- presence of images (MRI or cranial CT scan performed during the last 12 months) suggesting vascular disease including: multiple infarction involving large blood vessels or localised single infarction (angular gyrus, thalamus, anterior cerebral artery and posterior cerebral artery region), multiple lacunae of the basal nuclei or white matter or extensive lesions of the periventricular white matter or combination of several lesions.
•- Patient with known vitamin B12 or folate deficiency (unless having received supplements at a stable dose for at least 6 months prior to selection) or known syphilis,
•- Patients with hyperthyroidism or unstable thyroid disease (patients with a history of hypothyroidism will be allowed in the study if they are on stable dose of replacement and the TSH is in the normal range),
•- Patient with known sleep apnoea syndrome,
•- Presence of serious disease which may soon become life-threatening.

发起方