Chinese Medicine WT for Spinocerebellar Ataxia Type 3

Medicine, Chinese Traditional Clinical Trial

Official title:

Chinese Medicine WT for Elevating IGF-1 of Patients With Spinocerebellar Ataxia Type 3 - Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05038306
• Other study ID #: 200703
• Status: Completed
• Phase: Phase 2
• Start date: May 31, 2021
• Est. completion date: September 26, 2022

Study information

• Verified date: January 2023
• Source: Changhua Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 26, 2022
• Est. primary completion date: September 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• diagnosed as Spinocerebellar Ataxia type 3

Exclusion Criteria:

• 1. using other Chinese medicine or herbal medicine 2. allergic to Chinese medicine or herbal medicine 3. pregnancy or breast feeding 4. with other major diseases, such as cancer, stroke, heart failure, or renal failure

Related Conditions & MeSH terms

• Ataxia
• Ataxia, Spinocerebellar
• Cerebellar Ataxia
• Insulin-Like Growth Factor I
• Machado-Joseph Disease
• Medicine, Chinese Traditional
• Spinocerebellar Ataxias
• Spinocerebellar Degenerations

Intervention

Drug:
• Chinese medicine WT
The Chinese medicine WT is thought to be neurotrophic, and its major constituent may benefit IGF-1 in animal studies, or certain healthy human group. WT is safe in clinical use in Asia.

Locations

Country	Name	City	State
Taiwan	Changhua Christian Hospital	Changhua

Sponsors (1)

Lead Sponsor	Collaborator
Changhua Christian Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Insulin-like Growth Factor 1 at week 12, or from week 16 to week 28	Insulin-like growth factor I is appropriate to observe the change for a period instead of the absolute value.	baseline and 12 weeks, or 16 weeks and 28 weeks, 32 weeks
Primary	Change from baseline in Neurofilament light Chain at week 12, or from week 16 to week 28	Neurofilament light Chain is appropriate to observe the change for a period instead of the absolute value	baseline and 12 weeks, or 16 weeks and 28 weeks, 32 weeks
Secondary	Change from baseline in scale for the assessment and rating of ataxia(SARA) at week 12, or from week 16 to week 28	scores of SARA are from 0 to 40, with higher scores means worse outcome	baseline and 12 weeks, or 16 weeks and 28 weeks
Secondary	Change from baseline in Modified Fatigue Impact Scale (MFIS) at week 12, or from week 16 to week 28	scores of MFIS are from 0 to 84, with higher scores means worse outcome	baseline and 12 weeks, or 16 weeks and 28 weeks
Secondary	Change from baseline in Epworth Sleepiness Scale (ESS) at week 12, or from week16 to week 28	scores of ESS are from 0 to 24, with higher scores means worse outcome	baseline and 12 weeks, or 16 weeks and 28 weeks
Secondary	Change from baseline in Hand-grip strength test (HST) at week 12, or from week16 to week 28	HST is appropriate to observe the change for a period instead of the absolute value	baseline and 12 weeks, or 16 weeks and 28 weeks
Secondary	Change from baseline in mitochondria DNA (mtDNA) at week 12, or from week16 to week 28	mitochondrial DNA HST is appropriate to observe the change for a period instead of the absolute value	baseline and 12 weeks, or 16 weeks and 28 weeks
Secondary	Change from baseline in 8_OHdG at week 12, or from week16 to week 28	8_OHdG is appropriate to observe the change for a period instead of the absolute value	baseline and 12 weeks, or 16 weeks and 28 weeks
Secondary	Change from baseline in ?Ct at week 12, or from week16 to week 28	?Ct is appropriate to observe the change for a period instead of the absolute value	baseline and 12 weeks, or 16 weeks and 28 weeks
Secondary	Change from baseline in serum metabolites at week 12, or from week 16 to week 28	serum metabolites is appropriate to observe the change for a period instead of the absolute value. Till now, there was no sufficient data about the metabolites of Chinese WT, so we would like to measure the difference of metabolites before and after taking the Chinese medicine WT.	baseline and 12 weeks, or 16 weeks and 28 weeks