NCT04950647

Efficacy and Safety of Nitrazine in the Treatment of ALS

Efficacy and Safety of Nitrazine in the Treatment of Amyotrophic Lateral Sclerosis: a Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 45 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This trial was a randomized, double-blind, placebo-controlled parallel design. Patients with ALS were selected by inclusion exclusion criteria, and then randomly assigned to receive either the experimental drug or placebo. Test group 1: Nitroketazine tablet 600mg group (Nitroketazine 300mg tablet x2 + placebo 300mg tablet x2 each time; If the subject progresses and cannot take 300 mg tablets, Nitroketazine 100mg tablets x6 tablets + placebo 100mg tablets x6 tablets can be taken instead). 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 100 mg tablets x12 tablets can be taken instead). Control group: placebo group (placebo 300mg tablets x4 tablets each orally; If subjects progress and cannot take 300 mg tablets, they may take placebo 100mg tablets x 12 tablets instead). Usage: Oral administration, twice a day, once in the morning and once in the evening (or the interval between two medication is 28h), at least 1" hour before meal (21 h before meal) on an empty stomach or at least 2 hours after meal (22h after meal) on an empty stomach, 180±3 days. Eligible subjects will start treatment on Day 1 after randomization, and visit the study center at the end of 1, 3, and 6 (or when they quit the study midway) for safety and efficacy checks. Telephone interviews were conducted at the end of the seventh day of treatment, the end of the second month, the end of the fourth month, the end of the fifth month of treatment, and the second week after the end of the sixth month of treatment. A total of 150 ALS patients were planned to be enrolled, with 50 patients in each group.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2020-07-01
• Primary completion: 2022-07-31
• Completion: 2022-12-31
• First posted: 2021-07-06
• Last updated: 2021-07-06

Locations

1 site across 1 country: China