This trial is active, not recruiting.

Condition paraparesis spastic tropical
Treatments valproic acid, costicosteroids, valproid acid plus corticosteroids
Phase phase 3
Target HDAC
Sponsor University of Sao Paulo
Start date February 2008
End date September 2009
Trial size 60 participants
Trial identifier NCT00681980, 278


Is the valproic acid efficacy to treat TSP/HAM

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Patients with side effects to corticosteroids
valproic acid
15 mg/kg/day
patient with corticosteroids
metypredsolone 1 g/day
Valproic acid and corticosteroids
valproid acid plus corticosteroids
valporid acid 15 mg/kg/day plus corticosteroids 1 g/patient

Primary Outcomes

Neurological sacles
time frame: 24 months

Secondary Outcomes

Quality of life
time frame: 2009

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - HTLV-1; TSP/HAM fulfill criteria Exclusion Criteria: - Age <18 years

Additional Information

Official title Study Of Valproic Acid To Treat TSP/HAM Patients In Sao Paulo, Brazil
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by University of Sao Paulo.