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Clinical study of crizotinib in the treatment of amyotrophic lateral sclerosis

Clinical study of crizotinib in the treatment of amyotrophic lateral sclerosis

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092197
Enrollment
Unknown
Registered
2024-11-12
Start date
2024-12-01
Completion date
Unknown
Last updated
2024-11-18

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

Conditions

Amyotrohic Lateral Sclerosi

Interventions

Experimental group:crizotinib 250mg/d

Sponsors

Yichang Central People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) The subject must be between 18 and 80 years of age (inclusive) at the time of signing the informed consent. (2)Diagnosis of probable, clinically probable ALS, clinically probable laboratory-supported ALS, or clinically definite ALS according to the revised El Escorial World Federation of Neurology criteria. (3)The duration of ALS(The time from the first symptom onset to the screening visit) <= 2 years. (4)The ability to take or receive oral medication. (5) Signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Participated in other clinical studies within 3 months; (2) Endotracheal intubation or invasive ventilation; (3) Pregnant and lactating women; (4) ALT or AST greater than 3 times normal;The total bilirubin was increased by more than 2 times the upper limit of the normal range; (5) Creatinine clearance <50ml/min; (6) Disease or injury that interferes with functional assessment or is life-threatening, (7) Any known non-ALS-related amyotrophic lateral sclerosis; (8) Major mental illness, cognitive impairment; (9) Interstitial lung disease, QT prolongation, and bradycardia; (10) Coagulopathy;Patients with impaired liver and kidney function;The presence of proteinuria at a moderate to high level; (11) Was unwilling or unable to participate in and complete the study.

Design outcomes

Primary

MeasureTime frame
Serum RIPK1;Serum IL-8;

Secondary

MeasureTime frame
Blood routine;Urine routine;Stool routine;Blood coagulation function;Liver and kidney function;Vital signs;Self-assessment questionnaire;

Countries

China

Contacts

Public ContactJun Wei

Yichang Central People's Hospital

junwei@ctgu.edu.cn+86 150 9092 2368

Outcome results

None listed

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