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Efficacy and Safety of Primidone in the Treatment of Amyotrophic Lateral Sclerosis: A Single-Center Retrospective Study

Efficacy and Safety of Primidone in the Treatment of Amyotrophic Lateral Sclerosis: A Single-Center Retrospective Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500112978
Enrollment
Unknown
Registered
2025-11-21
Start date
2025-11-24
Completion date
Unknown
Last updated
2025-11-24

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

Conditions

Amyotrophic lateral sclerosis

Interventions

Observation group:None

Sponsors

Yichang Central People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Creatinine clearance < 50 mL/min; 3. Any disease or injury that would interfere with functional assessments or be life-threatening; 4. Any known non-ALS related motor neuron disease; 5. Significant psychiatric illness or cognitive impairment; 6. History of localized inflammation or chronic systemic inflammatory disease prior to medication; 7. Pre-existing visual changes, diplopia, nystagmus, ataxia, porphyria, asthma, chronic obstructive pulmonary disease (COPD), or other respiratory conditions that may exacerbate dyspnea or airway obstruction; 8. Significant cardiac, renal, hepatic, or other systemic diseases; 9. Unwilling or unable to participate in the study; 10. Lack of essential data or inability to obtain qualified biological samples.

Design outcomes

Primary

MeasureTime frame
ALSRFS-R Scale Score;

Secondary

MeasureTime frame
ROADS Scale Score;CNS-BFS Scale Score ;Daily Life Function Scale Score;Walking test;Blood RIPK1 levels;Blood RIPK3 levels;Blood MLKL levels;Blood p-RIPK1 levels;Blood p-RIPK3 levels;Blood p-MLKL levels;Swallowing function;Pulmonary function;

Countries

China

Contacts

Public ContactYunhong Zha

Yichang Central People's Hospital

fyzhayunhong@nbu.edu.cn+86 138 7266 2508

Outcome results

None listed

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