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The safety and effectiveness of primidone in the treatment of amyotrophic lateral sclerosis: A single-center, retrospective cohort study

A single-center, retrospective cohort study to evaluate the safety and effectiveness of primidone in the treatment of amyotrophic lateral sclerosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200060149
Enrollment
Unknown
Registered
2022-05-20
Start date
2022-06-01
Completion date
Unknown
Last updated
2024-04-22

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

case series:None

Sponsors

The First Hospital of Yichang
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. ALS patients treated in the First People's Hospital of Yichang from April 2021 to April 2022; 2. Aged >=18 years; 3. Diagnosis of clinically positive, probable and probable ALS in accordance with the revised IE Escorial standards (1998); 4. Primidone (62.5-125 mg/day) was applied; 5. Informed consent for off-label drug use has been signed.

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating patients; 2. Creatinine clearance <50ml/min; 3. Diseases or injuries that interfere with functional evaluation or endanger life; 4. Any known motor neurone disease not associated with ALS; 5. Major mental illness, cognitive dysfunction; 6. History of localized inflammation or chronic systemic inflammation before taking medication; 7. Patients suffering from vision changes, diplopia, nystagmus, ataxia, porphyria, wheezing, chronic obstructive pulmonary disease or other respiratory diseases that may aggravate breathing difficulties or airway obstruction before taking medication; 8. The presence of major heart, kidney, liver or other systemic diseases; 9. Unwillingness or inability to participate in the study.

Design outcomes

Primary

MeasureTime frame
Patient Self-Assessment Questionnaire;Modified ALS Functional Score;ROADS Scale;CNS-BFS Scale;Forced vital capacity;Walking test;

Secondary

MeasureTime frame
Serum RIPK1 and RIPK3 levels;Inflammatory cytokin;Urine factor;

Countries

China

Contacts

Public ContactZha Yunhong

The First Hospital of Yichang

junwei@ctgu.edu.cn+86 13872662508

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026