Chinese Medicine WT for Spinocerebellar Ataxia Type 3

October 22, 2021 updated by: Chiu Chung Min, Changhua Christian Hospital

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

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Changhua, Taiwan, 500
        • Recruiting
        • Changhua Christian Hospital
        • Contact:
          • Chung-Min Chiu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
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.
Active Comparator: Chinese Medicine
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Insulin-like Growth Factor 1 at week 12, or from week 16 to week 28
Time Frame: baseline and 12 weeks, or 16 weeks and 28 weeks, 32 weeks
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
Change from baseline in Neurofilament light Chain at week 12, or from week 16 to week 28
Time Frame: baseline and 12 weeks, or 16 weeks and 28 weeks, 32 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in scale for the assessment and rating of ataxia(SARA) at week 12, or from week 16 to week 28
Time Frame: baseline and 12 weeks, or 16 weeks and 28 weeks
scores of SARA are from 0 to 40, with higher scores means worse outcome
baseline and 12 weeks, or 16 weeks and 28 weeks
Change from baseline in Modified Fatigue Impact Scale (MFIS) at week 12, or from week 16 to week 28
Time Frame: baseline and 12 weeks, or 16 weeks and 28 weeks
scores of MFIS are from 0 to 84, with higher scores means worse outcome
baseline and 12 weeks, or 16 weeks and 28 weeks
Change from baseline in Epworth Sleepiness Scale (ESS) at week 12, or from week16 to week 28
Time Frame: baseline and 12 weeks, or 16 weeks and 28 weeks
scores of ESS are from 0 to 24, with higher scores means worse outcome
baseline and 12 weeks, or 16 weeks and 28 weeks
Change from baseline in Hand-grip strength test (HST) at week 12, or from week16 to week 28
Time Frame: baseline and 12 weeks, or 16 weeks and 28 weeks
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
Change from baseline in mitochondria DNA (mtDNA) at week 12, or from week16 to week 28
Time Frame: baseline and 12 weeks, or 16 weeks and 28 weeks
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
Change from baseline in 8_OHdG at week 12, or from week16 to week 28
Time Frame: baseline and 12 weeks, or 16 weeks and 28 weeks
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
Change from baseline in △Ct at week 12, or from week16 to week 28
Time Frame: baseline and 12 weeks, or 16 weeks and 28 weeks
△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
Change from baseline in serum metabolites at week 12, or from week 16 to week 28
Time Frame: baseline and 12 weeks, or 16 weeks and 28 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2021

Primary Completion (Anticipated)

October 5, 2022

Study Completion (Anticipated)

October 5, 2022

Study Registration Dates

First Submitted

May 27, 2021

First Submitted That Met QC Criteria

September 5, 2021

First Posted (Actual)

September 9, 2021

Study Record Updates

Last Update Posted (Actual)

October 26, 2021

Last Update Submitted That Met QC Criteria

October 22, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ataxia, Spinocerebellar

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  • Biohaven Pharmaceuticals, Inc.
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  • University of California, Los Angeles
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  • University of Chicago
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  • University of Florida
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  • Assistance Publique - Hôpitaux de Paris
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Clinical Trials on Chinese medicine WT

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