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Dietary Supplement

Neo-ASA for Argininosuccinate Lyase Deficiency

N/A
Waitlist Available
Led By Sandesh C Nagamani, M.D.
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

Study Summary

This trial will study the effects of a dietary supplement on cognition in patients with a rare genetic disorder.

Eligible Conditions
  • Argininosuccinate Lyase Deficiency
  • Urea Cycle Disorders
  • Urea Cycle Deficiencies
  • Argininosuccinic Aciduria

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Conners Continuous Performance Test - 3rd Edition Conners Continuous Performance Test - 3rd Edition
Delis-Kaplan Executive Function System - Tower subtest
Grip Strength
+4 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Neo-ASAActive Control1 Intervention
During this arm the participant will receive a lozenge with nitric oxide as a dietary supplement twice daily.
Group II: PlaceboPlacebo Group1 Intervention
During this arm the participant will receive a lozenge which will not contain nitric oxide as a dietary supplement twice daily.

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,001,936 Total Patients Enrolled
1 Trials studying Argininosuccinate Lyase Deficiency
12 Patients Enrolled for Argininosuccinate Lyase Deficiency
Rare Diseases Clinical Research NetworkNETWORK
67 Previous Clinical Trials
19,089 Total Patients Enrolled
Neogenis LaboratoriesOTHER
5 Previous Clinical Trials
178 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the trial encompass minors, or are participants required to be over 18?

"As per the inclusion criteria, prospective participants must be between 6 and 50 years of age."

Answered by AI

Is this trial presently enrolling volunteers?

"According to the details on clinicaltrials.gov, this medical trial is currently seeking participants and was initially listed in September 2017 with its last update occurring in August 2022."

Answered by AI

What is the aggregate size of this medical study's population?

"Affirmative. According to the research available on clinicaltrials.gov, this medical investigation is currently accepting individuals for participation. The initial post was made on September 15th 2017 and updated most recently in August 5th 2022. In total 16 people across one trial site are required for enrollment."

Answered by AI

Who is allowed to partake in this medical research?

"This clinical trial is welcoming sixteen individuals with urea cycle disorders, who are between six and fifty years of age. Furthermore, participants must provide a negative pregnancy test result, comply with the study diet and treatment plan, and agree to use an effective contraception for its entire duration (if applicable). Males enrolled in this research endeavour should also ensure their partners abide by these same contraceptive protocols."

Answered by AI
~2 spots leftby Apr 2025