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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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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:
Evaluation of the neuroprotector effect of an extract of stem bark of Mangifera indica L. (Vimang®) in patient with Spinocerebellar Hereditary Ataxia Type 2
Secondary indentifying numbers:
Not applicable
Issuing authority of the secondary identifying numbers:
Not applicable
Primary sponsor:
Center of Pharmaceutical Chemistry
Secondary sponsor:
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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