Ataxia type SCA-2
Conditions
Interventions
Group I (Study group). Rehabilitation + Zinc. Physical rehabilitation program and 1 daily dose of Zinc 50 mg orally. Treatment duration: 6 months. Group II (Control group). Rehabilitation + Placebo. P
Sponsors
Drug Research and Development Center (CIDEM)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: -Patients with ataxia type 2 (SCA-2) in in stages I-II -Age rank of participants from 18 to 60 inclusive, resident in Holguín -Subjects of both sexes -Liver and kidney functions among normal patterns -Not presenting dementia -Not to have ingested another medication during the 15 previous days neither having donated blood during the previous 3 months -With normal vital signs Systolic blood pressure *140 mm of Hg Diastolic blood pressure *90 mm of Hg Cardiac frequency 60-100 x min Respiratory frequency 16-20 x min -Complementary examinations of Hematology, HQ and urine within normal ranges established and declared in Section 13.1 of this protocol -Patients with CAG repetitions over 31 units -Written consent of patient
Exclusion criteria
Exclusion criteria: -History of allergy, idiosyncrasy or hypersensitivity to the drug -Ingestion of alcohol during the 3 previous days -Individuals with alcoholism or drug addiction background -Patients with any neurological or systemic disorder affecting the nervous system -Patients with acute diseases at the moment of inclusion -Patients with decompensated chronic disorders associated to SCA-2 -Pregnancy or breastfeeding -Background or clinical evidence of the following pathologies: liver, heart, kidney, clotting or respiratory disorders, anemia or any other chronic disorders -Patients under treatment with immunosuppressive drugs -Any surgery performed during 6 months before the trial -Not meet any criteria for inclusión
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total zinc content of blood serum (mmol/L), Measurement time: at baseline, 3 months after treatment and 6 months after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Total content of iron and copper in blood serum (mmol/L), measuring time: at baseline, 3 months after treatment and 6 months after treatment. Total content of zinc, iron and copper in cerebrospinal fluid(CSF) (mg/L), measuring time: at baseline, and 6 months after treatment. Values SOD, CAT, GST, TBARS, GSH, and Cu-Zn SOD in blood serum, measurement time: at baseline, 3 months after treatment and 6 months after treatment Values SOD, CAT, GST, TBARS, GSH, and Cu-Zn SOD in cerebrospinal fluid(CSF) Measurement time: at baseline and 3 months after treatment. Electrophysiological and neurocognitive variables, measurement time: at baseline, 3 months after treatment and 6 months after treatment. Adverse events, measuring time: 3 months after treatment and 6 months after treatment. | — |
Countries
Cuba
Contacts
Public ContactJorge E. Rodríguez Chanfrau
Centro de Investigacion y Desarrollo de Medicamentos. (CIDEM)
Outcome results
None listed