Trial of Amivita in Amyotrophic Lateral Sclerosis

NCT03103815 | Unknown

• 1 other identifier: WJ2017001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic lateral sclerosis, survival, adverse event

Outcome Measures

Primary Outcomes (2)

• ALS Functional Rating Scale-Revised (ALSFRS-R) score

  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

  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 Outcomes (2)

• Forced vital capacity (FVC)

  10 months

• EQ-5D

  10 months

Other Outcomes (2)

• Grisp strength

  10 months

• body weigh

  10 months

Study Arms (1)

experimental group

EXPERIMENTAL

Experimental group will receive Amivita.

Drug: Amivita

Interventions

Amivita DRUG

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,

experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wujin People's Hospital: lead
• Nanjing 1718: collaborator

Study Sites (1)

Wujing People's Hospital

Changzhou, Jiangsu, 213002, China

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Maoxin Yue, M.D

  Wujing People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shidie Zhu, M.Sci

CONTACT

86-519-85579128; 513325835@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a self-controlled trial. All participants will receive treatment.

Study Record Dates

• First Submitted: April 1, 2017
• First Posted: April 6, 2017
• Study Start: April 24, 2017
• Primary Completion: October 20, 2018
• Study Completion: October 20, 2018
• Last Updated: April 26, 2017

Record last verified: 2017-04

Locations

CN (1)