Amyotrophic Lateral SclerosisNCT03103815
Trial of Amivita in Amyotrophic Lateral Sclerosis
A study testing Amivita in people with Amyotrophic Lateral Sclerosis, run by Wujin People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Amivita
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 24 Apr 2017to 20 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Myotonic dystrophy
- Myasthenia gravis
- Post-poliomyelitis syndrome
- Multifocal motor neuropathy with or without conduction block
- Hirayama disease
- Kennedy disease
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wujing People's Hospital
Changzhou, Jiangsu, 213002
Shidie Zhu, Master, 86-519-85579128, 513325835@qq.com
Lianming Liao, M.D
About this study
Official title: Trial of Amivita in Amyotrophic Lateral Sclerosis: a Single-center, Single-blind, Self-controlled Clinical Trial
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.
Read the 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
- Being tested
- Amivita
- Keywords
- Amyotrophic lateral sclerosis, survival, adverse event
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmivitaDrug
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,
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Experimental group will receive Amivita. Receives: Drug: Amivita |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 10 months
Secondary outcomes (2)
Forced vital capacity (FVC)
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.
Measured: 10 months
EQ-5D
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.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start24 Apr 2017
- Primary completion20 Oct 2018 (estimated)
- Study completion20 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a self-controlled trial. All participants will receive treatment.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wujin People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing 1718
- Responsible party
- Sponsor
- Investigators
- Maoxin Yue, M.D, Principal investigator, Wujing People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103815
- Sponsor's protocol ID
- WJ2017001
- Status last verified
- Apr 2017
- First submitted
- 1 Apr 2017
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Amivita in Amyotrophic Lateral Sclerosis: a Single-center, Single-blind, Self-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03103815
- Acronym / sponsor ID
- WJ2017001
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Amyotrophic lateral sclerosis, survival, adverse event
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Wujin People's HospitalUniversity, hospital or other
- Collaborators
- Nanjing 1718
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 20 Oct 2018 (estimated)
- Study completion
- 20 Oct 2018 (estimated)
- First posted
- 6 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a self-controlled trial. All participants will receive treatment.
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: AmivitaExperimental group will receive Amivita. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (18 listed)
- Myotonic dystrophy
- Myasthenia gravis
- Post-poliomyelitis syndrome
- Multifocal motor neuropathy with or without conduction block
- Hirayama disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmivitaIn 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, | Drug | experimental group |
Primary outcome
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.
2 secondary outcomes
Forced vital capacity (FVC)
Time frame: 10 months
EQ-5D
Time frame: 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maoxin Yue, M.D principal investigator
Wujing People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amivita in people with Amyotrophic Lateral Sclerosis, run by Wujin People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shidie Zhu, M.Sci (86-519-85579128, 513325835@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ALS Functional Rating Scale-Revised (ALSFRS-R) score (time frame: 10 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2017.