Evaluation of the neuroprotector effect of an extract of stem bark of Mangifera indica L. (Vimang®) in patient with Spinocerebellar Hereditary Ataxia Type 2

Phase 2

• Conditions: Spinocerebellar Hereditary Ataxia Type 2; Spinocerebellar Ataxias; Cerebellar Ataxia; Ataxia; Spinocerebellar Degenerations; Cerebellar Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Spinal Cord Diseases

• Registration Number: RPCEC00000005
• Lead Sponsor: Center of Pharmaceutical Chemistry

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1.Patients with diagnosis of SCA2 of any sex from 18 up to 60 years old, both inclusive.
2. Patient able to develop basic activities of the daily life with independence (according to Barthel scale).
3. Time of evolution of the illness until or smaller than 15 years.
4. Patient that voluntarily accept to participate in the clinical trial, by means of the signature of the informed consent.

Exclusion Criteria

1.Patients with antecedents of alcoholism.
2. Patients with antecedents of any other illness with repercussion in the nervous system.
3. Patient with non controlled chronic illnesses.
4. Pregnancy or nursing.
5. Patient with renal or hepatic failure.
6. Patients with inmunosupresores tratment or with other antioxidant treatment.
7. Patients that participate in another clinical trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
atency of the saccade velocity. This variable will be measured to the beginning, to the 3 months and the 6 months.

Secondary Outcome Measures

Name	Time	Method
Degree of motor coordination. This variable includes: -equilibrium -march Electrophysiological variables: a) Saccade velocity b) Studies of Peripheric and Sensitive Nervous Conduction of the sural and medium nerves: PESS of medium nerve with registration in tip Erb, N13 and N20, to all will be measured latency and conduction speed. c)Intervalometry in spontaneous breathings: It will be measured mean, standard deviation and the indexes of high-low frequency of the successive differences. These variables will be measured to the beginning, to the 3 months and the 6 months.