Trial of Amivita in Amyotrophic Lateral Sclerosis

NCT ID: NCT03103815

Last Updated: 2017-04-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-24
• Study Completion Date: 2018-10-20

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.

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studies, we have shown that Amivita, a compound of amino acids and vitamines, is effective for neuronal injury (unpublished data).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 Our retrospective analysis (unpublished data) of the treated patient indicates that this regimen can slow down the progression of ALS.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

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

experimental group

Experimental group will receive Amivita.

Group Type: EXPERIMENTAL

Amivita

Intervention Type: 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,

Interventions

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,

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing 1718

OTHER

Sponsor Role: collaborator

Wujin People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maoxin Yue, M.D

Role: PRINCIPAL_INVESTIGATOR

Wujing People's Hospital

Locations

Wujing People's Hospital

Changzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shidie Zhu, M.Sci

Role: CONTACT

513325835@qq.com

86-519-85579128

Facility Contacts

Shidie Zhu, Master

Role: primary

513325835@qq.com

86-519-85579128

Other Identifiers

WJ2017001

Identifier Type: -

Identifier Source: org_study_id