Back to resultsEfficacy and Safety of Nitrazine in the Treatment of ALS
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Nitrofurazone Group 1
Nitroketazine Group 2
placebo group
Sponsored by
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Sites / Locations
- Peking University Third HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Test group 1
Test group 2
Control group
Arm Description
Nitroketazine tablet 600 mg group
Nitroketazine tablets 1200 mg group
placebo group
Outcomes
Primary Outcome Measures
ALSFRS-R score
ALSFRS -r score difference between the difference in value relative to the baseline group;
Secondary Outcome Measures
grip strength
Intergroup differences in grip strength relative to baseline difference
Full Information
NCT ID
NCT04950647
First Posted
June 27, 2021
Last Updated
June 27, 2021
Sponsor
Peking University Third Hospital
Collaborators
West China Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04950647
Brief Title
Efficacy and Safety of Nitrazine in the Treatment of ALS
Official Title
Efficacy and Safety of Nitrazine in the Treatment of Amyotrophic Lateral Sclerosis: a Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
Collaborators
West China Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test group 1
Arm Type
Experimental
Arm Description
Nitroketazine tablet 600 mg group
Arm Title
Test group 2
Arm Type
Experimental
Arm Description
Nitroketazine tablets 1200 mg group
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
placebo group
Intervention Type
Drug
Intervention Name(s)
Nitrofurazone Group 1
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Nitroketazine Group 2
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
placebo group
Intervention Description
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).
Primary Outcome Measure Information:
Title
ALSFRS-R score
Description
ALSFRS -r score difference between the difference in value relative to the baseline group;
Time Frame
Treatment day 180
Secondary Outcome Measure Information:
Title
grip strength
Description
Intergroup differences in grip strength relative to baseline difference
Time Frame
Treatment day 180
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dongsheng Fan
Phone
+86 13701023871
Email
dsfan@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dongsheng Fan
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100098
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongsheng Fan
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Efficacy and Safety of Nitrazine in the Treatment of ALS
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