Determining the Safety of L-serine in ALS
Determining the Safety of L-Serine in Subjects With Amyotrophic Lateral Sclerois (ALS) at Varied Doses.
2 other identifiers
interventional
20
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 27, 2013
CompletedFirst Posted
Study publicly available on registry
April 19, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedJuly 30, 2015
July 1, 2015
3.9 years
March 27, 2013
July 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of L-Serine
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
1-6 months
Secondary Outcomes (1)
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
1-6 months
Study Arms (4)
2.5 grams BID
ACTIVE COMPARATOR5 Patients will be evenly randomized into this group
.5 grams BID
ACTIVE COMPARATOR5 Patients will be evenly randomized into this group
7.5 grams BID
ACTIVE COMPARATOR5 Patients will be evenly randomized into this group
15 grams BID
ACTIVE COMPARATOR5 Patients will be evenly randomized into this group
Interventions
Eligibility Criteria
You may qualify if:
- Age 18-85
- Male or Female
- Clinically diagnosed with probable or definite ALS based on El Escorial criteria
- ALSFRS-R \> 25
- Able to provide informed consent to and comply with all medical procedures
You may not qualify if:
- Outside age range of 18-85
- Subjects with forced vital capacity (FVC) below 60%
- Evidence of any motor neuron disease for over 3 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Phoenix Neurological Associates, LTDlead
- Institute for Ethnomedicinecollaborator
Study Sites (2)
Phoenix Neurological Associates
Phoenix, Arizona, 85018, United States
Forbes Norris MDA/ALS Research Center
San Francisco, California, 94115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Todd D Levine, MD
Phoenix Neurological Associates, LTD
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2013
First Posted
April 19, 2013
Study Start
January 1, 2013
Primary Completion
December 1, 2016
Last Updated
July 30, 2015
Record last verified: 2015-07