Trial Outcomes & Findings for Efficacy Study of Metadoxine SR Formulation in Attention Deficit Hyperactivity Disorder (ADHD) Subjects (NCT NCT00995085)

Results Overview

Subjects were evaluated for general safety and tolerablity measures, including number of AEs and AEs related (possibly or likely) to study drug

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

43 participants

Primary outcome timeframe

24 hours after drug adminstration

Results posted on

2017-03-13

Participant milestones
Measure	Metadoxine SR Metadoxine is a pyrolate salt of Pyridoxine
Overall Study STARTED	43
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	5

Reasons for withdrawal
Measure	Metadoxine SR Metadoxine is a pyrolate salt of Pyridoxine
Overall Study Withdrawal by Subject	5

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

Baseline characteristics by cohort
Measure	Metadoxine SR n=43 Participants Metadoxine is a pyrolate salt of Pyridoxine
Age, Continuous	32.1 years STANDARD_DEVIATION 6.9 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Region of Enrollment Israel	43 participants n=5 Participants

Timeframe: 24 hours after drug adminstration

Subjects were evaluated for general safety and tolerablity measures, including number of AEs and AEs related (possibly or likely) to study drug

Outcome measures
Measure	Metadoxine SR n=43 Participants Metadoxine is a pyrolate salt of Pyridoxine
Safety and Tolerability	2 events

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Metadoxine SR n=38 participants at risk Metadoxine is a pyrolate salt of Pyridoxine
General disorders Tiredness	5.3% 2/38 • Number of events 2

Alcobra Inc

Phone: 610-504-7814

Restriction type: LTE60