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Determining the Safety of L-serine in ALS

This study is currently recruiting participants.
Verified April 2013 by Phoenix Neurological Associates, LTD
Sponsor:
Collaborator:
Institute for Ethnomedicine
Information provided by (Responsible Party):
Phoenix Neurological Associates, LTD
ClinicalTrials.gov Identifier:
NCT01835782
First received: March 27, 2013
Last updated: April 18, 2013
Last verified: April 2013
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2013
Estimated Primary Completion Date: November 2013 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01835782

Contacts
Contact: Nicole C Hank, MHSM 602 258 2432 nhank@pnal.net

Locations
United States, Arizona
Phoenix Neurological Associates Recruiting
Phoenix, Arizona, United States, 85018
Contact: Nicole C Hank, MHSM    602-258-2432    nhank@pnal.net   
Sponsors and Collaborators
Phoenix Neurological Associates, LTD
Institute for Ethnomedicine
Investigators
Principal Investigator: Todd D Levine, MD Phoenix Neurological Associates, LTD
  More Information

No publications provided

Responsible Party: Phoenix Neurological Associates, LTD
ClinicalTrials.gov Identifier: NCT01835782     History of Changes
Other Study ID Numbers: L-Serine2013, IND
Study First Received: March 27, 2013
Last Updated: April 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Phoenix Neurological Associates, LTD:
ALS
L-Serine
BMAA

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014