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Amino Acid

L-Serine Safety for ALS

Phase 1 & 2
Waitlist Available
Led By Todd D Levine, MD
Research Sponsored by Phoenix Neurological Associates, LTD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-85
Male or Female
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-6 months
Awards & highlights

Study Summary

This trial will test the safety of L-Serine in people with ALS. Different doses will be given to see what is safe.

Who is the study for?
This trial is for men and women aged 18-85 who have been clinically diagnosed with ALS, a motor neuron disease, and can follow the study's procedures. They should be relatively early in their diagnosis (not over 3 years) and still have decent lung function (FVC above 60%).Check my eligibility
What is being tested?
The trial is testing the safety of different doses of L-Serine, an amino acid, to see how well patients with ALS tolerate it.See study design
What are the potential side effects?
Since this study aims to determine the safety of L-Serine in ALS patients, potential side effects are being investigated but may include gastrointestinal discomfort or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 85 years old.
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I am either male or female.
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My ALS functional rating score is above 25.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety of L-Serine
Secondary outcome measures
Measure levels of β-Methylamino-L-alanine (BMAA) in blood, urine and Cerebrospinal fluid (CSF) to determine if there is a decline in levels over the course of treatment

Trial Design

4Treatment groups
Active Control
Group I: 2.5 grams BIDActive Control1 Intervention
5 Patients will be evenly randomized into this group
Group II: .5 grams BIDActive Control1 Intervention
5 Patients will be evenly randomized into this group
Group III: 7.5 grams BIDActive Control1 Intervention
5 Patients will be evenly randomized into this group
Group IV: 15 grams BIDActive Control1 Intervention
5 Patients will be evenly randomized into this group

Find a Location

Who is running the clinical trial?

Phoenix Neurological Associates, LTDLead Sponsor
7 Previous Clinical Trials
204 Total Patients Enrolled
Institute for EthnomedicineUNKNOWN
Todd D Levine, MDPrincipal InvestigatorPhoenix Neurological Associates, LTD
3 Previous Clinical Trials
138 Total Patients Enrolled

Media Library

L-Serine (Amino Acid) Clinical Trial Eligibility Overview. Trial Name: NCT01835782 — Phase 1 & 2
Lou Gehrig's Disease Research Study Groups: 2.5 grams BID, .5 grams BID, 7.5 grams BID, 15 grams BID
Lou Gehrig's Disease Clinical Trial 2023: L-Serine Highlights & Side Effects. Trial Name: NCT01835782 — Phase 1 & 2
L-Serine (Amino Acid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01835782 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies within this research protocol available for participants?

"Clinicaltrials.gov reports that this particular medical trial, which was initially posted on 1st January 2013 and last amended on 28th July 2015 is not currently enrolling patients. However, there are 146 other studies actively recruiting at the moment."

Answered by AI

Are applicants under the age of forty welcome to enroll in this clinical experiment?

"The prerequisite of this trial necessitates that potential participants be between 18 and 85 years old."

Answered by AI

Can I become a participant in this clinical investigation?

"This trial is seeking 20 participants with amyotrophic lateral sclerosis to join. To be eligible, candidates must range between 18 and 85 years of age."

Answered by AI

What is the approximate number of individuals taking part in this experiment?

"At this moment, the trial is not taking on patients. It was first posted on January 1st 2013 and last updated July 28th 2015. If you are searching for other options, there are currently 142 clinical trials recruiting participants with amyotrophic lateral sclerosis and 4 studies actively seeking people to take 15 grams BID (twice daily)."

Answered by AI

To what maladies is a 15 gram twice-daily dosage typically prescribed?

"Iron insufficiency, amino acid deficiency disorder, and other related medical conditions can be remedied with 15 grams of the substance taken twice daily."

Answered by AI

What other empirical research has been conducted involving a 15-gram twice daily administration?

"Initially studied in 2013 at Phoenix Neurological Associates, 15 grams BID has been the focus of 16 separate clinical trials. At present, four distinct studies are still recruiting patients; three taking place in San Francisco and one elsewhere."

Answered by AI
~2 spots leftby Mar 2025