Phase 1
Completed N=43
Efficacy Study of Metadoxine SR Formulation in Attention Deficit Hyperactivity Disorder (ADHD) Subjects
Source: ClinicalTrials.gov NCT00995085 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Jul 2011
Primary outcomePrimary: Safety and Tolerability — 2 events
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability |
2 | — |
Eligibility Criteria
Inclusion Criteria
- age 18-45
- diagnosed as ADHD
Exclusion Criteria
- PDD patients
- head injured patients
- patients suffering from heart, lung, liver, kidney, intestinal, endocrine an neurological diseases and patients who are sensitive to vitamin B
Data sourced from ClinicalTrials.gov (NCT00995085). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.