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

• Register: RPCEC
• Last refreshed on: 27 May 2013
• Main ID: RPCEC00000005
• Date of registration: 13/03/2009
• Primary sponsor: Center of Pharmaceutical Chemistry
• Public title: Evaluation of the neuroprotector effect of an extract of stem bark of Mangifera indica L. (Vimang®) in patient with Spinocerebellar Hereditary Ataxia Type 2
• Scientific title: Evaluation of the neuroprotector effect of an extract of stem bark of Mangifera indica L. (Vimang®) in patient with Spinocerebellar Hereditary Ataxia Type 2
• Date of first enrolment: 30/03/2008
• Target sample size: 20
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000005-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Placebo Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Dr. Mariela Guevara-Garcia
• Affiliation: Center of Pharmaceutical Chemistry

• Name: Dr. Mariela Guevara-Garcia
• Affiliation: Center of Pharmaceutical Chemistry

Key inclusion & exclusion criteria

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.

Age minimum: 18 years
Age maximum: 60 years
Gender: Both

Health Condition(s) or Problem(s) studied

Spinocerebellar Hereditary Ataxia Type 2

Intervention(s)

Will be conformed two treatment groups according to an aleatory list. One group will receive Vimang® (orally) to a daily dose of 1 800 mg, divided in two pills (300 mg each) three times a day, far from the foods, during 6 months. The other group will receive placebo in same frequency. In both groups will be combined with a Program of Physical Rehabilitation of same period of duration.

Primary Outcome(s)

Latency of the saccade velocity. This variable will be measured to the beginning, to the 3 months and the 6 months.

Secondary Outcome(s)

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.

Source(s) of Monetary Support

Ministry of Public Health