Efficacy and Safety of Nitrazine in the Treatment of ALS

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the trend of safety and effectiveness of Nitroketazine tablets for ALS patients, and to explore the best effective dose.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University Third Hospital
• Collaborator: West China Hospital
• Treatments: Nitrofurazone

Criteria

Inclusion Criteria:

1. Age 45-70, gender unlimited (including 45 and 70);

2. diagnoses in accordance with the confirmed and proposed ALS diagnostic standards ofthe Revised World Federation of Neurology (1998);

3. The duration of disease from onset to randomization of subjects is less than 2 years;

4. Before randomization, ALSFRS-R scores were ≥2 points, and respiratory function items were 4 points;

5. ALSFRS-R decreased by 1-4 points in screening period 3A (≥1 and lt; 4);

6. Random pre-respiratory function Forced Vital Capacity (%FVC) ≥80%;

7. Understand and abide by the test procedures, participate voluntarily, and sign the informed consent (the informed consent should be signed by the person or the guardian voluntarily).

Exclusion Criteria:

1. Familial ALS (judged by family history);

2. Patients with significant cognitive impairment (MMSE: illiteracy group < 19 points, elementary school. 22 points, S26 points in the junior high school and above group (more than 8 years of education);

3. obvious dysphagia;

4. Severe renal insufficiency: creatinine clearance. 30 mL/min (Cockcroft-Gault formula), or other known severe renal insufficiency;

5. Severe liver function impairment: ALT, AST> 3 times the upper limit of normal value, or other known liver diseases such as acute or chronic active hepatitis, cirrhosis, etc.;

6. In the screening stage, patients with heart failure who developed acute myocardial infarction or underwent interventional therapy within the last 6 months (grade II1-IV according to NYHA);

7. Complicated with malignant tumors, serious diseases of blood, digestion or other systems.

8. Allergic to experimental drugs or ligustrazine;

9. Pregnancy and lactation;

10. Participated in, or is participating in, other clinical trials within 30 days prior to screening;

11. The investigator did not consider it appropriate to participate in this study.