E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Fatigue symptoms in Parkinson's disease. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10013113 |
E.1.2 | Term | Disease Parkinson's |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy of 6 months treatment with DC158AM on fatigue in patients with Parkinson’s disease. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |