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Determining the Safety of L-serine in ALS

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ClinicalTrials.gov Identifier: NCT01835782
Recruitment Status : Unknown
Verified July 2015 by Phoenix Neurological Associates, LTD.
Recruitment status was:  Active, not recruiting
First Posted : April 19, 2013
Last Update Posted : July 30, 2015
Sponsor:
Collaborator:
Institute for Ethnomedicine
Information provided by (Responsible Party):
Phoenix Neurological Associates, LTD

Tracking Information
First Submitted Date  ICMJE March 27, 2013
First Posted Date  ICMJE April 19, 2013
Last Update Posted Date July 30, 2015
Study Start Date  ICMJE January 2013
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2013)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Determining the Safety of L-serine in ALS
Official Title  ICMJE Determining the Safety of L-Serine in Subjects With Amyotrophic Lateral Sclerois (ALS) at Varied Doses.
Brief Summary The purpose of this study is to determine the safety of L-Serine in subjects with Amyotrophic Lateral Sclerosis (ALS) at varied doses.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Amyotrophic Lateral Sclerosis (ALS)
Intervention  ICMJE Drug: L-Serine
Study Arms  ICMJE
  • Active Comparator: 2.5 grams BID
    5 Patients will be evenly randomized into this group
    Intervention: Drug: L-Serine
  • Active Comparator: .5 grams BID
    5 Patients will be evenly randomized into this group
    Intervention: Drug: L-Serine
  • Active Comparator: 7.5 grams BID
    5 Patients will be evenly randomized into this group
    Intervention: Drug: L-Serine
  • Active Comparator: 15 grams BID
    5 Patients will be evenly randomized into this group
    Intervention: Drug: L-Serine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 18, 2013)
20
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01835782
Other Study ID Numbers  ICMJE L-Serine2013
IND ( Other Identifier: 116871 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Phoenix Neurological Associates, LTD
Study Sponsor  ICMJE Phoenix Neurological Associates, LTD
Collaborators  ICMJE Institute for Ethnomedicine
Investigators  ICMJE
Principal Investigator: Todd D Levine, MD Phoenix Neurological Associates, LTD
PRS Account Phoenix Neurological Associates, LTD
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP