Status:
UNKNOWN
Explore Neuroprotective Effect of Lipoic Acid in Amyotrophic Lateral Sclerosis
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
20-75 years
Phase:
NA
Brief Summary
In this proposed study, the investigators will evaluate the safety and efficacy of lipoic acid in treatment of Amyotrophic lateral sclerosis (ALS). The study will recruit 150 AD patients, and then the...
Detailed Description
In this proposed study, the investigators will evaluate the safety and efficacy of Lipoic acid in treatment of ALS. The study will recruit 150 ALS patients, then these patients will be randomized to l...
Eligibility Criteria
Inclusion
- Age range from 20 to 75 (including 20 and 75 years old), regardless of ethnic group or gender;
- The subjects should meet the diagnostic criteria for ALS by El Escorial revised criteria: "Definite ALS", "Probable ALS" and "Probable, laboratory-supported ALS".
- ALS Functional Rating Scale-Revised (ALSFRS-R 12 items) each item score ≥2 points;
- The onset (the symptoms of limbs weakness, muscle atrophy or bulbar involvement ) of the disease is less than 2 years
- Baseline breath function: Forced Vital Capacity≥70% .
- Disease Progression Rate FS=(48- ALSFRS-R at "time of diagnosis")/duration from onset to diagnosis (month), progression rate FS≤1;
Exclusion
- Combined with one of cerebrovascular disease, spinal cord disease, spinal muscular atrophy, juvenile myoatrophy of distal upper extremity, multifocal motor neuropathy, Kennedy disease, epilepsy, etc;
- Severe renal insufficiency: creatinine clearance rate \<30 mL/min (Cockcroft-Gault formula, urea nitrogen and (or) blood creatinine\> 1.5 times the upper limit of normal, or other known severe renal insufficiency diseases;
- Severe liver damage: ALT, AST\> 3 times the upper limit of normal, or other known liver diseases such as acute and chronic hepatitis, cirrhosis, etc.;
- Obvious tachycardia or bradycardia; patients with acute myocardial infarction or interventional therapy in the past 6 months (patients with grade III-IV according to NYHA classification);
- Combined with malignant tumor, blood, digestion or other serious diseases;
- Female patients during pregnancy and lactation;
- Participated in other clinical trials within 30 days before randomization, or are participating in other clinical trials;
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04518540
Start Date
September 1 2020
End Date
October 1 2022
Last Update
August 19 2020
Active Locations (1)
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1
Second Affiliated Hospital,Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009