Amyotrophic Lateral SclerosisPhase 2NCT07467746
Research of Traditional Chinese Medicine Oral Preparation of C. Cicadae in the Treatment of ALS Patients With Elevated Plasma Sphingolipids
A Phase 2 study testing C. cicadae in people with Amyotrophic Lateral Sclerosis, run by The Third Xiangya Hospital of Central South University.
Trial summary
Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease characterized by the degeneration of motor neurons, leading to progressive muscle weakness and functional decline. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- C. cicadae
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Apr 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ALS diagnosed according to the revised El Escorial criteria.
- Significantly elevated plasma levels of key SL molecules (e.g., Cer(d18:0/24:0), Cer(d18:1/22:0), and other relevant molecules), meeting the predefined cut-off values for metabolic stratification.
- Time from disease onset to enrollment ≤24 months
- For participants receiving riluzole and/or edaravone, the dose must have been stable for at least 30 days prior to enrollment.
- Male or non-pregnant, non-lactating female patients, aged > 18 and ≤ 80 years old.
- Voluntarily participate in clinical trials, sign informed consent, and be able to understand and abide by research procedures.
Who cannot join
- Presence of peripheral neuropathy or motor neuron injury attributable to other clearly defined etiologies and sufficient to interfere with disease classification in this study, including but not limited to vitamin deficiency, toxic neuropathy, drug- or chemotherapy-related neuropathy, alcoholic neuropathy, paraneoplastic syndrome, autoimmune neuropathy, and infection-related neuropathy;
- Severe hepatic or renal dysfunction that may affect the safety evaluation of the investigational product or the interpretation of metabolomics results;
- Severe cardiopulmonary dysfunction, active infection, active malignancy, or other major systemic diseases that, in the opinion of the investigator, may significantly affect prognosis assessment or completion of follow-up;
- Women who are pregnant or breastfeeding, or who plan to become pregnant during the study period;
- Participation in another interventional clinical trial within 30 days prior to enrollment, or being within the washout period of another investigational product;
- Inability to comply with clinical assessments, sample collection, or follow-up procedures;
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- Persistent high dependence on noninvasive ventilation (>16 hours/day), or advanced respiratory failure as judged by the investigator, such that the participant is unable to complete oral intervention and efficacy evaluation;
- Severe dysphagia, gastrointestinal dysfunction, or other conditions rendering the participant unable to tolerate oral administration;
- Known allergy to C. cicadae preparations, fungal products, or any of their excipients;
- Concomitant diseases or conditions that may substantially affect motor function assessment and thereby interfere with evaluation of the primary endpoint;
- Any other condition that, in the opinion of the investigator, makes the participant unsuitable for study participation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Single-center Study of Traditional Chinese Medicine Oral Preparation of C. Cicadae in the Treatment of ALS Patients With Elevated Plasma Sphingolipids
Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease characterized by the degeneration of motor neurons, leading to progressive muscle weakness and functional decline. This study is designed as a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of an oral preparation of C. cicadae in patients with sporadic ALS and elevated plasma sphingolipid (SL) levels. Efficacy will be assessed primarily by changes in the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) score and plasma SL levels.Participants who meet the eligibility criteria and provide written informed consent will be randomly assigned in a 1:1 ratio to either the C. cicadae treatment group or the placebo group. The treatment group will receive oral C. cicadae at a dose of 0.1 g/kg/day (dry weight), administered in three divided doses per day. The placebo group will receive a matched placebo with a similar appearance and odor, administered according to the same schedule. A total of approximately 84 participants will be enrolled. The intervention period will be 6 months, and participants will be followed for a total of 9 months.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- C. cicadae, Control
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C. cicadaeDrug
The oral C. cicadae preparation will be administered at a dose of 0.1 g/kg/day, divided into three oral doses, with a maximum total daily dose of 10 g. The investigational C. cicadae preparation will be centrally prepared by the Department of Pharmacy, the Third Xiangya Hospital of Central South University.
ControlDrug
A placebo identical to the investigational product in appearance, odor, and dosage form, formulated with dextrin, caramel coloring, and other excipients, and confirmed by sensory testing to be indistinguishable from the investigational product.
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | In addition to standard therapy (riluzole 50 mg twice daily, with or without concomitant edaravone), participants will receive a placebo matched to the investigational product in appearance, odor, and dosage form. The placebo is formulated with dextrin, caramel coloring, and other excipients, and sensory testing has confirmed that it is indistinguishable from the investigational product. Receives: Drug: Control |
| C. cicadae | Experimental | In addition to standard therapy (riluzole 50 mg twice daily, with or without concomitant edaravone), participants will receive an oral preparation of the traditional Chinese medicine C. cicadae. In this study, the dose of C. cicadae is set at 0.1 g/kg/day, administered orally in three divided doses, with a maximum total daily dose of 10 g. The investigational C. cicadae preparation will be centrally prepared by the Department of Pharmacy of the Third Xiangya Hospital, Central South University. Receives: Drug: C. cicadae |
What is being measured
The primary outcome is the main question the study is designed to answer.
sphingolipid (SLs) levels
Measured: 9 months
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) scores
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467746
- Sponsor's protocol ID
- ThirdXiangyaHCSU-2025-S006
- Status last verified
- May 2026
- First submitted
- 8 Mar 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No