An interventional study of Antrodia cinnamomea Products and Antrodia cinnamomea Products in Spinocerebellar Ataxia, sponsored by ALPS Biotech CO. LTD. Recruiting at 1 site in Taiwan. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-12-10.
Sponsored by ALPS Biotech CO. LTD · Not applicable, Interventional, and Health services research
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Among 10 studies in Spinocerebellar Ataxias with a site in Taiwan — 4 open to participants now, 5 under way, none of them phase 3. Spinocerebellar Ataxias · Taiwan.
Among the 10 studies in Spinocerebellar Ataxias with a site in Taiwan, this one is the 2nd largest by planned enrollment, is one of 3 that started in 2024, is one of 7 with no phase, and was the 9th registered.
95 studies on the registry are indexed under Spinocerebellar Ataxias; 25 are open to participants now.
Browse Spinocerebellar Ataxias studies →4 of the 10 studies in Spinocerebellar Ataxias with a site in Taiwan are open now. Recruiting first, the newest first:
Chang Gung University · Sites in Taiwan
Ages 18+
Changhua Christian Hospital · Sites in Taiwan
Ages 18–65
Chang Gung University · Sites in Taiwan
Ages 20+ · Healthy volunteers
A study can be open while its sites in Taiwan have not opened yet or have stopped. Only those recruiting at a site in Taiwan →
Of the 16 Spinocerebellar Ataxias studies recruiting now, 8 (50%) set no upper age limit and 3 (19%) stop at 75 or younger; 4 take children under 18; 5 take healthy volunteers.
This study: 30 Years to 70 Years · all sexes · no healthy volunteers.
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10 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 3 started in 2024.
This study's planned enrollment of 60 is above the median of 29 across 61 interventional studies indexed under Spinocerebellar Ataxias.
Median enrollment 40 across the 10 interventional studies. Of the 5 that completed or were terminated, 0 (0%) have results posted.
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3 of 10 have an industry lead sponsor. The 5 most frequent:
This is the only study on the registry with ALPS Biotech CO. LTD as lead sponsor.
ALPS Biotech CO. LTD has 1 study filed under Spinocerebellar Ataxias — fewer than ten, so there is no comparison to draw.
2 of the studies in Spinocerebellar Ataxias with a site in Taiwan that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06672445Arrowhead PharmaceuticalsStudy of ARO-ATXN2 Injection in Adults With Spinocerebellar Ataxia Type 2 | 2026-12 |
| NCT06633003ALPS Biotech CO. LTDEffects of Oral Administration of Antrodia Cinnamomea Products for Clinical Symptoms in Spinocerebellar Ataxia Patients | 2027-08-31 |
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Among the 10 studies in Spinocerebellar Ataxias with a site in Taiwan, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This study aims to assess the effect of Antrodia cinnamomea on clinical symptoms in spinocerebellar ataxia patients. To investigate the advancements in neurodegenerative diseases.
This study aims to assess the effect of Antrodia cinnamomea on clinical symptoms in spinocerebellar ataxia patients: a randomized, double-blind, placebo-controlled crossover design, and parallel clinical investigation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Crossover design: During 0 week\~8 weeks is Stage I : • Dietary Supplement: Antrodia Cinnamomea Products During 16 weeks\~ 24 weeks is Stage II: • Dietary Supplement: Placebo
Dietary Supplement: Antrodia cinnamomea Products
Crossover design: During 0 week\~8 weeks is Stage I : • Dietary Supplement: Placebo During 16 weeks\~ 24 weeks is Stage II: • Dietary Supplement: Antrodia Cinnamomea Products
Dietary Supplement: Antrodia cinnamomea Products
Placebo-controlled crossover design: * Dietary Supplement: Antrodia Cinnamomea Products * Dietary Supplement: Placebo
A arm : Stage I : • Dietary Supplement: Antrodia Cinnamomea Products Stage II: • Dietary Supplement: Placebo B arm : Stage I : • Dietary Supplement: Placebo Stage II: • Dietary Supplement: Antrodia Cinnamomea Products
Change from Baseline in the total score of the Scale for the Assessment and Rating of Ataxia (SARA) at 48 weeks in subjects is compared to natural history.
To compare the effectiveness of Antrodia Cinnamomea Products in treating SCA, as measure by the Scale for the Assessment and Rating of Ataxia (SARA), in subjects randomized to treatment after 24 weeks of treatment. The SARA is a scale with a range of 0 to 40, where an increase in the total score indicates a worsening of symptoms.
Time frame: Up to 48 weeks of treatment.
Resting-state electroencephalogram (EEG) will be collected
Successful attainment of Resting-state electroencephalogram (EEG). To compare the EEG recordings in different frequency band change before, during, and after the Antrodia Cinnamomea Products used.
Time frame: Up to 48 weeks of treatment.
Collect Cytokines assay of plasma exosomes and Neurofilament Light Chain (NfL) Test of plasma.
Monitor Cytokines assay of plasma exosomes and Neurofilament Light Chain (NfL) Test of plasma.
Time frame: Up to 48 weeks of treatment.
The Nine-Hole Peg Test (9HPT) is used to measure finger dexterity in patients with various neurological diagnoses.
The Nine-Hole Peg Test (9HPT) is used to measure finger dexterity in patients with various neurological diagnoses. The evaluator should start the stopwatch as soon as the patient touches the first peg. The evaluator should stop the stopwatch once the last peg is in the container. Scoring: The number of seconds it takes for the patient to complete the test, where an increase in the total score indicates a worsening of symptoms.
Time frame: Up to 48 weeks of treatment.
Changes From Start of Administration (Week 0) in Pittsburgh Sleep Quality Index (PSQI) Global Score at End of Study.
PSQI is a self-rated questionnaire for sleep quality. It includes 18 items across 7 components; C1: Sleep quality, C2: Sleep latency, C3: Sleep duration, C4: Sleep efficiency, C5: Sleep disturbance, C6: Use of sleep medication, C7: Daytime dysfunction. Each component is scored 0-3 (0 = no difficulty, 3=severe difficulty), and total score ranging from 0 to 21. It included seven components with a global PSQI score \> 5 is indicative of poor sleep quality.
Time frame: Up to 48 weeks of treatment.
Hospital Anxiety and Depression Scale (HADS)
Hospital Anxiety and Depression Scale (HADS) questionnaire. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.
Time frame: Up to 48 weeks of treatment.
The 8 Metre Walk Test.
The 8 Metre Walk Test is a performance measure used to assess walking or gait speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function Scoring The total time taken to ambulate 8 meters is recorded. Timing starts when the toes pass the 0-meter mark. Timing stops when the toes pass the 8-meter mark. The 8-meter is then divided by the total time taken (in seconds) to completed. Increase in the total time indicates a worsening of symptoms.
Time frame: Up to 48 weeks of treatment.
Check Fecal levels of Human Calprotectin and Fecal levels of Human Lactoferrin.
Check Fecal levels of Human Calprotectin and Fecal levels of Human Lactoferrin.
Time frame: Up to 48 weeks of treatment.
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2024 (actual). Primary completion is estimated for Aug 2027, 35 months after the start.
Of 28 interventional studies with no phase under Spinocerebellar Ataxias, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 35 months is above that.
How these figures are worked out, and which studies are left out of them.
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