A Clinical Outcomes Study to Measure Reduction in Pain and Numbness During Administration of an Amino Acid Formulation in Subjects Diagnosed With Peripheral Neuropathy
Neuron012703
1 other identifier
interventional
24
1 country
1
Brief Summary
A clinical outcomes study measuring reduction in pain and numbness experienced in four types of peripheral neuropathy patients during 60 day administration of the an amino acid formulation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2012
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2012
CompletedFirst Posted
Study publicly available on registry
February 23, 2012
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedFebruary 23, 2012
February 1, 2012
4 months
February 15, 2012
February 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
VAS
To measure reduction in pain related to various types of peripheral neuropathy during administration of study intervention using a Visual Analog Scale.
60 Days
Secondary Outcomes (2)
NTSS-6
60 Days
Routine Blood Panel
60 days
Study Arms (1)
Neuron012703
EXPERIMENTALAmino acid formulation for the dietary management of symptoms related to periphal neuropathy.
Interventions
Eligibility Criteria
You may qualify if:
- Confirmation of peripheral neuropathy diagnosis from physician.
- Subjects able to read and understand English.
- Subjects willing to commit to all study visits for the duration of administration.
- Male and non-pregnant/lactating females, ages 18 to 75.
You may not qualify if:
- Subjects hospitalized within the last 30 days.
- History of nerve surgery.
- Currently taking other medical foods.
- Existing serious medical condition (i.e. severe heart, liver or kidney disease).
- Subjects with measured creatinine greater than 2.5, ALT or AST greater than three times normal.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gabriel Halperin DPM Inc
Los Angeles, California, 90063, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gabriel Halperin, DPM
Gabriel Halperin DPM Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2012
First Posted
February 23, 2012
Study Start
March 1, 2012
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
February 23, 2012
Record last verified: 2012-02