STUDY OF EFFECTIVENESS, TOLERABILITY AND SAFETY OF THERAPY WITH AMANTADINE IN DEGENERATIVE ATAXIAS

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

- Age equal or greater than 18 and less than 85 years
- Patients with degenerative ataxias with scores between 8 and 34 points on the SARA scale
- Patients with and without cardiomyopathy
- Can be included patients stably treated with idebenone and / or riboflavin and / or deferiprone or darbepoetin for at least 1 year
- Having given informed consent
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

- Age under 18 or over 85 years
- SARA Scale score <8 and> 34 points
- Impared to proximal level muscle strength of lower extremity in a grade ? 4 points in the Gradual Neurological Scale
- Sensory function (primary modes + estereognosia) altered at a rate of ? 9 Gradual Neurological Scale
- Significant neurological disease that may affect cognition: dementia, Down syndrome
- Current presence of disorder or clinically significant psychiatric symptoms (eg hallucinations), according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), which may affect the patient's ability to complete the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the efficacy of amantadine in patients with degenerative ataxias mild to moderate, as mediating the SARA scale. Determine changes in blood levels of frataxin levels in patients with degenerative ataxias mild to moderate before and after starting treatment. Objectives of safety and tolerance.;Secondary Objective: - Echocardiography in the case of patients with Friedreich's Ataxia<br>- Neuro-ophthalmology rating <br>- Visual evoked potentials<br>- Otoneurological review<br>- Brain MRI<br>- Determine changes in blood levels of IGF-1 and fratraxina in patients with Friedreich's ataxia mild to moderate before and after starting treatment.;Primary end point(s): Neurological assessment<br>Otoneurological review;Timepoint(s) of evaluation of this end point: 12 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Brain MRI<br>Neuro-ophthalmology rating;Timepoint(s) of evaluation of this end point: 12 months

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STUDY OF EFFECTIVENESS, TOLERABILITY AND SAFETY OF THERAPY WITH AMANTADINE IN DEGENERATIVE ATAXIAS

Recruitment & Eligibility

Study & Design

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