NCT00995085

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 14, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
9 months until next milestone

Results Posted

Study results publicly available

July 6, 2011

Completed
Last Updated

March 13, 2017

Status Verified

June 1, 2011

Enrollment Period

1 year

First QC Date

October 13, 2009

Results QC Date

December 27, 2010

Last Update Submit

January 31, 2017

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHDADDTOVAMETADOXINE

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability

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

    24 hours after drug adminstration

Study Arms (1)

Metadoxine SR

EXPERIMENTAL

Metadoxine is a pyrolate salt of Pyridoxine

Drug: Extended Release Metadoxine

Interventions

Extended Release MetadoxineDRUG

one oral 1400mg dose (2 tablets)

Also known as: Metadoxine, Metadoxil
Metadoxine SR

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age 18-45
  • diagnosed as ADHD

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ADHD Unit, Geha MHC, Israel

Petah Tikva, Israel

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

metadoxine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Results Point of Contact

Title
Jonathan Rubin, MD, MBA
Organization
Alcobra Inc
jrubin@alcobra-pharma.com
610-504-7814

Study Officials

  • Iris Manor, MD

    Geha MC, Israel

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2009

First Posted

October 14, 2009

Study Start

October 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

March 13, 2017

Results First Posted

July 6, 2011

Record last verified: 2011-06

Locations

IL(1)