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

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Ministry of Public Health

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

12/02/2007

Reference number:

05-031-06 - N

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Luis

Last name:

Velázquez Pérez

Medical Specialty :

2nd Degree Specialist in Neurophysiology

Affiliation:

Clinic for the Research and Rehabilitation of the Hereditary Ataxias

Postal address:

Carretera Central Km 5 1/2. Vía Habana

City:

Havana

Country:

Cuba

Zip Code:

80100

Telephone:

+53-24424090

Email address:

ataxiacubana@ataxia.hlg.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not Applicable

Research ethics committees:

Clinic for the Research and Rehabilitation of the Hereditary Ataxias. May 17, 2006.

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

30/03/2008

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Spinocerebellar Hereditary Ataxia Type 2

Health condition(s) code:

Spinocerebellar Ataxias

Cerebellar Ataxia

Ataxia

Spinocerebellar Degenerations

Cerebellar Diseases

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Nervous System Diseases

Spinal Cord Diseases

Dyskinesias

Neurologic Manifestations

Genetic Diseases, Inborn

Brain Diseases

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.

Intervention code:

Mangifera indica

Exercise Therapy

Neuroprotective Agents

Antioxidants

Tablets

Administration, Oral

Placebos

Intervention keyword:

Vimang®

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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

Key secondary outcomes:

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.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

60 years

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

2

Target sample size:

20

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Mariela

Middle Name:

Margarita

Last Name:

Guevara-Garcia

Specialty:

1st Grade Specialist in Pharmacology

Affiliation:

Center of Pharmaceutical Chemistry

Postal Address:

21 Ave. and 200 St., Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

(537) 271 5067

Email :

marielaguevara@infomed.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Mariela

Middle Name:

Margarita

Last Name:

Guevara-Garcia

Specialty:

1st Grade Specialist in Pharmacology

Affiliation:

Center of Pharmaceutical Chemistry

Postal Address:

21 Ave. and 200 St., Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

(537) 271 5067

Email :

marielaguevara@infomed.sld.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000005

Date of Registration in Primary Registry:

2009-03-13

Record Verification Date:

2017/01/20

Next update date:

2018/01/20

Link to the spanish version:

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

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