Fatigue symptoms in Parkinson's disease. MedDRA version: 9.1 Level: LLT Classification code 10013113 Term: Disease Parkinson's
Conditions
Interventions
Trade Name: DEBRUMYL
Product Code: DC158AM
Pharmaceutical Form: Oral solution
INN or Proposed INN: Heptaminol hydrochloride
Concentratio
Sponsors
PIERRE FABRE MEDICAMENT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of 6 months treatment with DC158AM on fatigue in patients with Parkinson’s disease.; Secondary Objective: To evaluate changes in motor symptoms, To evaluate the effect on cognitive functions, To evaluate the behavioural effect, To evaluate the effect on activities of daily living, To evaluate the safety and tolerability of the product. ;Primary end point(s): The primary efficacy criterion will be the comparison between the active and placebo group of the mean variation of FSS score between baseline and week 24. | — |
Countries
France
Outcome results
None listed