Single-center Phase ? clinical study about different doses of sodium valproate by oral administration in treatment for SCA3/MJD patients

Randomized, double-blind, placebo-controlled, continuous 12-week oral administration of different doses of sodium valproate in treatment for SCA3/MJD patients and evaluation of safety and effectivenes

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-10000754

Enrollment

Unknown

Registered

2010-01-06

Start date

2009-05-15

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinocerebellar ataxia

Interventions

A:High-dosed oral administration of sodium valproate for 12 weeks

B:Low-dosed oral administration of sodium valproate for 12 weeks

C:Continuous oral administration of placebo for 12 w

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1) SCA3/MJD patients with MJD-1 gene mutations identified by genetic diagnosis; 2) Ages between 18-50 years; body mass index (BMI) in 19-25 kg/m^2(BMI = weight (Kg) / height (m) squared), including the boundary values; 3) Gait subitem score in SARA: <=5 points; Gait subitem score in ICARS: <=7 points; 4) Willing to participate in various stages of clinical trials and compliance is fine; 5) In the research phase, Women at childbearing age agreed to take two kinds of feasible ways for contraception ; 6) having not taken VAP, Chinese medicine and diet food one month before being selected; 7) understand and sign informed consent,and being willing to cooperate with physicians to complete the relevant treatment, inspection, follow-up.

Exclusion criteria

Exclusion criteria: 1) Subjects do not meet the standard health; 2) Women during pregnancy, breast-feeding; 3) Fever in the past three days; 4) Having participated in clinical trials of other drugs in the past three months; 5) Having drug-induced jaundice personal or family history; 6) Leukopenia or thrombocytopenia; 7) Major organ dysfunction; 8) Being suspected or indeed having alcohol, drug abuse history; 9) Allergies; 10) In addition to the current signs and symptoms caused by the SCA3/MJD, suffering obvious clinical symptoms and signs of other disease and applying drugs for prevention or treatment; 11) Other cases that researchers thought being not suitable to participate in clinical trials.

Design outcomes

Primary

Measure	Time frame
International Cooperation Ataxia Rating (ICARS rate);Ataxia rating score (SRAS ratings);	—

Secondary

Measure	Time frame
magnetic resonance spectroscopy(MRS) for cerebellur;Detection for biomarker;Non-ataxia score;	—

Countries

China

Contacts

Public ContactBeisha Tang

bstang7398@yahoo.com.cn+86 13974856709

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026