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Trial of Amivita in Amyotrophic Lateral Sclerosis

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ClinicalTrials.gov Identifier: NCT03103815
Recruitment Status : Unknown
Verified April 2017 by Wujin People's Hospital.
Recruitment status was:  Recruiting
First Posted : April 6, 2017
Last Update Posted : April 26, 2017
Nanjing 1718
Information provided by (Responsible Party):
Wujin People's Hospital

Brief Summary:
The primary objectives of this study are to determine the safety and efficacy of Amivita, a compound of amino acids and vitamines in patients with Amyotrophic lateral sclerosis (ALS)ALS. The secondary objectives are to measure quality of life before and during intervention. This is a self-controlled clinical trial. Twenty patients in our ALS center who are already receiving riluzole or other treatments but the condition is worsening will receive treatment for 1o 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. Subjects will also be assessed at enrollment and at study end for weight loss, forced vital capacity (FVC), quality of life and grip strength.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: Amivita Not Applicable

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studies, we have shown that Amivita, a compound of amino acids and vitamines, is effective for neuronal injury (unpublished data).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 Our retrospective analysis (unpublished data) of the treated patient indicates that this regimen can slow down the progression of ALS.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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
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.
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: experimental group
Experimental group will receive Amivita.
Drug: 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,

Primary Outcome Measures :
  1. 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

  2. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Other Outcome Measures:
  1. Grisp strength [ Time Frame: 10 months ]
    A simple measure of muscle ability.

  2. body weigh [ Time Frame: 10 months ]
    Body weigh loss is common for ALS patients and is a simple measure for clinical trial.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103815

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Contact: Shidie Zhu, M.Sci 86-519-85579128 513325835@qq.com

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China, Jiangsu
Wujing People's Hospital Recruiting
Changzhou, Jiangsu, China, 213002
Contact: Shidie Zhu, Master    86-519-85579128    513325835@qq.com   
Sub-Investigator: Lianming Liao, M.D         
Principal Investigator: Maoxin Yue, M.D         
Sponsors and Collaborators
Wujin People's Hospital
Nanjing 1718
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Principal Investigator: Maoxin Yue, M.D Wujing People's Hospital
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Responsible Party: Wujin People's Hospital
ClinicalTrials.gov Identifier: NCT03103815    
Other Study ID Numbers: WJ2017001
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wujin People's Hospital:
Amyotrophic lateral sclerosis, survival, adverse event
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases