Degenerative ataxias
Conditions
Interventions
Product Name: Amantadina
Pharmaceutical Form: Capsule, hard
CAS Number: 768-94-5
Other descriptive name: AMANTADINE HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: range
Concentr
Sponsors
FIBHULP
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: - Age under 18 or over 85 years - SARA Scale score 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 - Neuro-ophthalmology rating - Visual evoked potentials - Otoneurological review - Brain MRI - 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 Otoneurological review;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Brain MRI Neuro-ophthalmology rating;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Spain
Contacts
Public ContactMaria Yllescas
FIBHULP
Outcome results
None listed