Efficacy and Safety of Nitrazine in the Treatment of ALS

NCT04950647 | Unknown Phase 2 DMC

• 1 other identifier: D2020109
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• ALSFRS-R score

  ALSFRS -r score difference between the difference in value relative to the baseline group;

  Treatment day 180

Secondary Outcomes (1)

• grip strength

  Treatment day 180

Study Arms (3)

Test group 1

EXPERIMENTAL

Nitroketazine tablet 600 mg group

Drug: Nitrofurazone Group 1

Test group 2

EXPERIMENTAL

Nitroketazine tablets 1200 mg group

Drug: Nitroketazine Group 2

Control group

PLACEBO COMPARATOR

placebo group

Drug: placebo group

Interventions

Nitrofurazone Group 1 DRUG

Test group 1: Nitroketazine tablet 600 mg group (Nitroketazine 300 mg tablet X2 + placebo 300 mg tablet ×2 tablets each time; If the subject progresses and cannot take 300mg tablets, Nitroketazine 100mg tablets x6 + placebo 100mg tablets x6) can be replaced.

Test group 1

Nitroketazine Group 2 DRUG

Test group 2: Nitroketazine tablets 1200 mg group (each oral Nitroketazine 300 mg tablets x4 tablets; If the subject progresses and cannot take 300 mg tablets, Nitroketazine 100mg tablets x12 tablets can be taken instead).

Test group 2

placebo group DRUG

Control group: placebo group (placebo 300mg tablets x4 tablets each orally; If subjects progress and cannot take 300mg tablets, they may take placebo 100 mg tablets x 12 tablets instead).

Control group

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 45-70, gender unlimited (including 45 and 70);
• diagnoses in accordance with the confirmed and proposed ALS diagnostic standards ofthe Revised World Federation of Neurology (1998);
• The duration of disease from onset to randomization of subjects is less than 2 years;
• Before randomization, ALSFRS-R scores were ≥2 points, and respiratory function items were 4 points;
• ALSFRS-R decreased by 1-4 points in screening period 3A (≥1 and lt; 4);
• Random pre-respiratory function Forced Vital Capacity (%FVC) ≥80%;
• 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).

You may not qualify if:

• Familial ALS (judged by family history);
• 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);
• obvious dysphagia;
• Severe renal insufficiency: creatinine clearance. 30 mL/min (Cockcroft-Gault formula), or other known severe renal insufficiency;
• 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.;
• 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);
• Complicated with malignant tumors, serious diseases of blood, digestion or other systems.
• Allergic to experimental drugs or ligustrazine;
• Pregnancy and lactation;
• Participated in, or is participating in, other clinical trials within 30 days prior to screening;
• The investigator did not consider it appropriate to participate in this study.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• West China Hospital: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100098, China

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Dongsheng Fan

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongsheng Fan

CONTACT

+86 13701023871; dsfan@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 6, 2021
• Study Start: July 1, 2020
• Primary Completion: July 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 6, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)