- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05038306
Chinese Medicine WT for Spinocerebellar Ataxia Type 3
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
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Chung-Min Chiu
- Phone Number: 886-982-506-067
- Email: shongdiah@gmail.com
Study Locations
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Changhua, Taiwan, 500
- Recruiting
- Changhua Christian Hospital
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Contact:
- Chung-Min Chiu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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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.
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Active Comparator: Chinese Medicine
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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
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Insulin-like growth factor I is appropriate to observe the change for a period instead of the absolute value.
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baseline and 12 weeks, or 16 weeks and 28 weeks, 32 weeks
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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
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scores of SARA are from 0 to 40, with higher scores means worse outcome
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baseline and 12 weeks, or 16 weeks and 28 weeks
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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
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baseline and 12 weeks, or 16 weeks and 28 weeks
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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
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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
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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.
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baseline and 12 weeks, or 16 weeks and 28 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Genetic Diseases, Inborn
- Neurodegenerative Diseases
- Dyskinesias
- Spinal Cord Diseases
- Heredodegenerative Disorders, Nervous System
- Cerebellar Diseases
- Ataxia
- Cerebellar Ataxia
- Spinocerebellar Ataxias
- Spinocerebellar Degenerations
- Machado-Joseph Disease
Other Study ID Numbers
- 200703
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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Cadent TherapeuticsWithdrawnSpinocerebellar Ataxia Type 3 | Spinocerebellar Ataxias | Spinocerebellar Ataxia Type 1 | Spinocerebellar Ataxia Type 2 | Spinocerebellar Ataxia Type 6 | Spinocerebellar Ataxia Type 10 | Spinocerebellar Ataxia Type 7 | Spinocerebellar Ataxia Type 8 | Spinocerebellar Ataxia Type 17 | ARCA1 - Autosomal Recessive...United States
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Assistance Publique - Hôpitaux de ParisCompletedSpinocerebellar Ataxia Type 1 | Spinocerebellar Ataxia Type 2 | Spinocerebellar Ataxia, Autosomal Recessive 3 | Episodic Ataxia, Type 7France
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