- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03103815
Trial of Amivita in Amyotrophic Lateral Sclerosis
Trial of Amivita in Amyotrophic Lateral Sclerosis: a Single-center, Single-blind, Self-controlled Clinical Trial
Study Overview
Detailed Description
Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disorder affecting upper and lower motor neurons. Survival is typically 2 to 5 years from symptom onset; death is usually from respiratory paralysis. Standard therapy is with Riluzole 100 mg/day, a FDA approved treatment for ALS that has a small effect on survival. There is a strong need for more effective therapies in ALS.
In our previous studies, we have shown that Amivita, a compound of amino acids and vitamines, is effective for neuronal injury (unpublished data). We have since then use this regimen to treat ALS patients. Our retrospective analysis (unpublished data) of the treated patient indicates that this regimen can slow down the progression of ALS.
We proposed a self-controlled clinical trial to study the safety and efficacy of Amivita. Secondary outcome measures include weight and quality of life. Twenty subjects in our ALS center who are already receiving riluzole will receive treatment for 12 months. The evaluating investigators will be blinded to treatment assignment. Primary outcome measures will be adverse events, the ALS Functional Rating Scale-Revised (ALSFRS-R), and survival. Secondary outcome measures include body weight, forced vital capacity (FVC), quality of life and grip strength.
The total study length from first enrolled subject will be approximately 6 months.
Participants in this study will be subjects with familial or sporadic ALS diagnosed as probable, or definite, according to the World Federation of Neurology El Escorial criteria. Diagnostic and Inclusionary/Exclusionary criteria will be clearly outlined in the protocol.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shidie Zhu, M.Sci
- Phone Number: 86-519-85579128
- Email: 513325835@qq.com
Study Locations
-
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Jiangsu
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Changzhou, Jiangsu, China, 213002
- Recruiting
- Wujing People's Hospital
-
Contact:
- Shidie Zhu, Master
- Phone Number: 86-519-85579128
- Email: 513325835@qq.com
-
Sub-Investigator:
- Lianming Liao, M.D
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Principal Investigator:
- Maoxin Yue, M.D
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- Patients must be men or women between the ages of 18 and 70 years
- Patient is clinical definite or probable ALS by the hospitals listed in the protocol
- Women who are of child bearing potential must have a negative pregnancy test
- Willing to comply with the study visits
- Will not take riluzole during the study period
- Be able to sign informed consent document
Exclusion Criteria
- Myotonic dystrophy
- Myasthenia gravis
- Post-poliomyelitis syndrome
- Multifocal motor neuropathy with or without conduction block
- Hirayama disease
- Kennedy disease
- Hereditary spastic paraplegia
- Syringomyelia
- Spinal cord and brain stem tumors
- Paraneoplastic syndromes
- Severe liver or kidney disease disease
- Infection, severe diarrhea or vomiting
- Serious heart or lung diseases or malignant tumor history
- HIV infection
- Pregnancy or breastfeeding
- Have no ability to communicate
- Have participated in other clinical trials within 4 weeks
- Any form of substance abuse, psychiatric disorder, or other condition that, in opinion of the investigator, may interfere with the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: experimental group
Experimental group will receive Amivita.
|
In each course, Amivita solution (500ml) will be administrated i.v.
once daily for 4 weeks.
After an interval of 2 weeks, the participants will be treated again.
A total of 7 courses will be given,
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ALS Functional Rating Scale-Revised (ALSFRS-R) score
Time Frame: 10 months
|
The ALSFRS is a validated clinical rating scale that has been shown to accurately track progression of patients disability in ALS. Inclusion of assessment of ALSFRS-R score is an essential element of the ALS trial. design of ALS clinical trials |
10 months
|
Adverse event
Time Frame: 10 months
|
Significant adverse events in gastrointestinal and respiratory symptoms will be written in the adverse event log.
Safety laboratory studies will be drawn and site investigators will be notified by their clinical laboratories if there are any changes in the chemistry and liver functions tests.
|
10 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Forced vital capacity (FVC)
Time Frame: 10 months
|
Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration, measured in liters.
FVC is an sensitive test for ALS patient' muscle ability.
|
10 months
|
EQ-5D
Time Frame: 10 months
|
EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple measure of health for clinical appraisal.
|
10 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Grisp strength
Time Frame: 10 months
|
A simple measure of muscle ability.
|
10 months
|
body weigh
Time Frame: 10 months
|
Body weigh loss is common for ALS patients and is a simple measure for clinical trial.
|
10 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Maoxin Yue, M.D, Wujing People's Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WJ2017001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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