NCT05038306

Chinese Medicine WT for Spinocerebellar Ataxia Type 3

Completed Phase 2 Last updated 31 January 2023

What this trial tests

Phase 2 trial testing Chinese medicine WT in Ataxia, Spinocerebellar in 33 participants. Completed in 26 September 2022.

Timeline

31 May 2021

Primary endpoint
26 September 2022

26 September 2022

Quick facts

Lead sponsor	Changhua Christian Hospital
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	33
Start date	31 May 2021
Primary completion	26 September 2022
Estimated completion	26 September 2022
Sites	1 location across Taiwan

Drugs / interventions tested

• Chinese medicine WT — full drug profile →

Conditions studied

• Ataxia, Spinocerebellar — all drugs for Ataxia, Spinocerebellar →
• Insulin-Like Growth Factor I — all drugs for Insulin-Like Growth Factor I →
• Medicine, Chinese Traditional — all drugs for Medicine, Chinese Traditional →

Sponsor

Changhua Christian Hospital

Who can join

Adults 20 to 80, any sex, with Ataxia, Spinocerebellar or Insulin-Like Growth Factor I. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Spinocerebellar ataxia type 3 (SCA3) is one of autosomal dominant hereditary ataxias. Standing imbalance, unsteady gait, dysmetria, fatigue, and depression would occur gradually. There are no effective treatment or palliative methods for patients in the present days. However, low-dose growth hormone, or its downstream product, insulin-like growth factor I (IGF-1), may deter the progress of SCA3 in transgenic mice. The main bioactive constituent among the Chinese medicine WT possesses neuroprotective function against glutamate-induced toxicity, which is one major pathology of SCA3. It promotes neurogenesis, and increases the protein expression of IGF-1 in ischemic brains of rats. Thus, we designed a randomized, double-blind trial for patients with SCA3, if WT is a possible neuroprotective medicine.

All the subjects will be recruited from Changhua Christian Hospital. Diagnosis is confirmed by gene test and magnetic resonance image by a neurologist. They will be assigned in random and double blind, prescribed with 3 grams concentrated powder of WT or placebo, twice a day, for 12 weeks. After the washout period of 4 weeks, there will be a crossover of placebo or WT for another 12 weeks. After that, another 4-week rest will be followed by the end of trial. Check items in five check points include: 1. Blood examination (serum IGF-1, Neurofilament light chain, mitochondria copy number, 8\_OHdG, delta-Ct), 2.Neurological exam (Scale for the Assessment and Rating of Ataxia), 3. Questionnaires (Modified Fatigue Impact Scale, Epworth Sleepiness Scale), 4. Handgrip strength test (which is correlated to IGF-1 value in elderly), and 5. serum metabolites, . All the data will be disclosed after the end of trial. Paired-T test or Wilcoxon Ranked Sign Test will be operated in SPSS.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.