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The Impact of Primidone Treatment on Fluid Metabolomics in Patients with Amyotrophic Lateral Sclerosis: A Retrospective Study

The Impact of Primidone Treatment on Fluid Metabolomics in Patients with Amyotrophic Lateral Sclerosis: A Retrospective Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500115565
Enrollment
Unknown
Registered
2025-12-29
Start date
2025-12-31
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

amyotrophic lateral sclerosis (ALS)

Interventions

ALS patient group:none
Control group:none

Sponsors

Yichang Central People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. ALS patients who have been treated at the Xiling Campus of Yichang Central People's Hospital from April 2021 to the present. 2. Age >= 18 year; 3. Diagnosis meets the criteria for clinically definite, clinically probable, or clinically possible ALS according to the 1998 revised El Escorial criteria; or meets the Gold Coast diagnostic criteria for ALS; 4. Treatment with primidone (62.5-125 mg/day); 5. Signed informed consent for off-label use of the drug.

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding women; 2. Creatinine clearance < 50 mL/min; 3. Diseases or injuries that interfere with functional assessments or are life-threatening; 4. Any known non-ALS-related motor neuron diseases; 5. Severe psychiatric disorders or cognitive dysfunction; 6. History of localized inflammation or chronic systemic inflammatory diseases prior to medication; 7. History of vision changes, diplopia, nystagmus, ataxia, porphyria, asthma, chronic obstructive pulmonary disease (COPD), or other respiratory diseases that may worsen dyspnea or airway obstruction prior to medication; 8. Presence of major cardiac, renal, hepatic, or other systemic diseases; 9. Unwilling or unable to participate in the study; 10. Missing essential information or inability to obtain eligible biological samples.

Design outcomes

Primary

MeasureTime frame
Metabolome;

Secondary

MeasureTime frame
ALSRFS-R Scale Score;CNS-BFS Scale Score ;ROADS Scale Score;Daily Life Function Scale Score;Walking test;Swallowing function;Pulmonary function;RIPK1 levels;RIPK3 levels;MLKL levels;p-RIPK1 levels;p-RIPK3 levels;p-MLKL levels;TNF-a level;IL-8 level;

Countries

China

Contacts

Public ContactYe Zhi

Yichang Central People's Hospital

yezhi@ctgu.edu.cn+86 136 6114 8561

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026