Overview

This trial is active, not recruiting.

Condition amyotrophic lateral sclerosis (als)
Treatment l-serine
Phase phase 1/phase 2
Sponsor Phoenix Neurological Associates, LTD
Collaborator Institute for Ethnomedicine
Start date January 2013
End date December 2016
Trial size 20 participants
Trial identifier NCT01835782, IND, L-Serine2013

Summary

The purpose of this study is to determine the safety of L-Serine in subjects with Amyotrophic Lateral Sclerosis (ALS) at varied doses.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model factorial assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
5 Patients will be evenly randomized into this group
l-serine
(Active Comparator)
5 Patients will be evenly randomized into this group
l-serine
(Active Comparator)
5 Patients will be evenly randomized into this group
l-serine
(Active Comparator)
5 Patients will be evenly randomized into this group
l-serine

Primary Outcomes

Measure
Safety of L-Serine
time frame: 1-6 months

Secondary Outcomes

Measure
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
time frame: 1-6 months

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

Inclusion Criteria: 1. Age 18-85 2. Male or Female 3. Clinically diagnosed with probable or definite ALS based on El Escorial criteria 4. ALSFRS-R > 25 5. Able to provide informed consent to and comply with all medical procedures Exclusion Criteria: 1. Outside age range of 18-85 2. Subjects with forced vital capacity (FVC) below 60% 3. Evidence of any motor neuron disease for over 3 years

Additional Information

Official title Determining the Safety of L-Serine in Subjects With Amyotrophic Lateral Sclerois (ALS) at Varied Doses.
Principal investigator Todd D Levine, MD
Description Previous studies into the Guamian ALS-Parkinson's Dementia complex has identified β-methylamino-L-alanine (BMAA), as a potential neurotoxin responsible for this disease. BMAA is a non-essential amino acid and is produced by a cyanobacterium which is present in all ecosystems. Subsequently several groups have identified high concentrations of BMAA in brain tissues of patients from North America and Europe with several neurodegenerative diseases including ALS, Parkinson's Disease and Alzheimer's Diseases. It has been hypothesized that chronic intake of BMAA in the diet leads to mis-incorporation of the amino acid into brain proteins, where it produces slow neuronal damage and recent evidence has shown that BMAA is mis-incorporated into proteins in neuronal cell lines via seryl tRNA synthetase, thereby producing protein mis-folding and protein aggregates, leading to cell death. It has been demonstrated in mammalian neuronal cell cultures that exogenous L-serine could prevent the BMAA neurotoxin from being mis-incorporated into proteins, thereby preventing cell death and that very high doses of L-serine may compete with the transport of a number of non-essential amino acids across the blood-brain barrier via the y+ transporter. These findings have led us to believe that high doses of L-serine could possibly stop the mis-incorporation of BMAA into brain proteins which in turn would slow or even abate the progression of ALS. This study will determine the safety of different doses of L-serine given to ALS subjects at 0.5 gm twice daily (BID), 2.5gm BID, 7.5g BID or 15 grams BID for six months.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Phoenix Neurological Associates, LTD.