Trial of Amivita in Amyotrophic Lateral Sclerosis
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|ClinicalTrials.gov Identifier: NCT03103815|
Recruitment Status : Recruiting
First Posted : April 6, 2017
Last Update Posted : April 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis||Drug: Amivita||Not Applicable|
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studies, we have shown that Amivita, a compound of amino acids and vitamines, is effective for neuronal injury (unpublished data).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 Our retrospective analysis (unpublished data) of the treated patient indicates that this regimen can slow down the progression of ALS.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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a self-controlled trial. All participants will receive treatment.|
|Masking:||None (Open Label)|
|Masking Description:||The evaluating investigators will be blinded to treatment assignment. Patients in our center, include those participate in the trial and those receive standard therapy, will be evaluated by clinicians who do not know the trial.|
|Official Title:||Trial of Amivita in Amyotrophic Lateral Sclerosis: a Single-center, Single-blind, Self-controlled Clinical Trial|
|Actual Study Start Date :||April 24, 2017|
|Estimated Primary Completion Date :||October 20, 2018|
|Estimated Study Completion Date :||October 20, 2018|
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,
- 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
- 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.
- 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.
- 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.
- Grisp strength [ Time Frame: 10 months ]A simple measure of muscle ability.
- body weigh [ Time Frame: 10 months ]Body weigh loss is common for ALS patients and is a simple measure for clinical trial.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103815
|Contact: Shidie Zhu, M.Sciemail@example.com|
|Wujing People's Hospital||Recruiting|
|Changzhou, Jiangsu, China, 213002|
|Contact: Shidie Zhu, Master 86-519-85579128 firstname.lastname@example.org|
|Sub-Investigator: Lianming Liao, M.D|
|Principal Investigator: Maoxin Yue, M.D|
|Principal Investigator:||Maoxin Yue, M.D||Wujing People's Hospital|