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Efficacy Study of Metadoxine SR Formulation in Attention Deficit Hyperactivity Disorder (ADHD) Subjects

NCT00995085 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2017-03-13

Study results available
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Summary

This clinical study is designed to evaluate the safety and tolerability of a single oral administration of a Metadoxine slow release formulation to subjects diagnosed as having ADHD. Study also assess cognitive effects of such drug administration.

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

DRUG

Extended Release Metadoxine

one oral 1400mg dose (2 tablets)

Sponsors & Collaborators

  • Alcobra Ltd.

    lead INDUSTRY

Principal Investigators

  • Iris Manor, MD · Geha MC, Israel

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00995085 on ClinicalTrials.gov