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Determining the Safety of L-serine in ALS

This study is ongoing, but not recruiting participants.
Institute for Ethnomedicine
Information provided by (Responsible Party):
Phoenix Neurological Associates, LTD Identifier:
First received: March 27, 2013
Last updated: July 28, 2015
Last verified: July 2015
The purpose of this study is to determine the safety of L-Serine in subjects with Amyotrophic Lateral Sclerosis (ALS) at varied doses.

Condition Intervention Phase
Amyotrophic Lateral Sclerosis (ALS)
Drug: L-Serine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Determining the Safety of L-Serine in Subjects With Amyotrophic Lateral Sclerois (ALS) at Varied Doses.

Resource links provided by NLM:

Further study details as provided by Phoenix Neurological Associates, LTD:

Primary Outcome Measures:
  • Safety of L-Serine [ Time Frame: 1-6 months ]
    Determining the safety of L-Serine given at 0.5 gm twice daily (BID), 2.5gm BID, 7.5g BID or 15 grams BID for six months by assessing the total number of adverse events (AE)during treatment

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 [ Time Frame: 1-6 months ]

Estimated Enrollment: 20
Study Start Date: January 2013
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2.5 grams BID
5 Patients will be evenly randomized into this group
Drug: L-Serine
Active Comparator: .5 grams BID
5 Patients will be evenly randomized into this group
Drug: L-Serine
Active Comparator: 7.5 grams BID
5 Patients will be evenly randomized into this group
Drug: L-Serine
Active Comparator: 15 grams BID
5 Patients will be evenly randomized into this group
Drug: L-Serine

Detailed 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.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01835782

United States, Arizona
Phoenix Neurological Associates
Phoenix, Arizona, United States, 85018
United States, California
Forbes Norris MDA/ALS Research Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
Phoenix Neurological Associates, LTD
Institute for Ethnomedicine
Principal Investigator: Todd D Levine, MD Phoenix Neurological Associates, LTD
  More Information

Responsible Party: Phoenix Neurological Associates, LTD Identifier: NCT01835782     History of Changes
Other Study ID Numbers: L-Serine2013
IND ( Other Identifier: 116871 )
Study First Received: March 27, 2013
Last Updated: July 28, 2015

Keywords provided by Phoenix Neurological Associates, LTD:

Additional relevant MeSH terms:
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases processed this record on May 25, 2017