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Efficacy and Safety of Nitrazine in the Treatment of ALS

NCT04950647 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-07-06

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Nitrofurazone Group 1

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.

DRUG

Nitroketazine Group 2

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).

DRUG

placebo group

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).

Sponsors & Collaborators

  • West China Hospital

    collaborator OTHER

  • Peking University Third Hospital

    lead OTHER

Principal Investigators

  • Dongsheng Fan · Peking University Third Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2022-07-31
Completion
2022-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04950647 on ClinicalTrials.gov