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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status

Completed

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

Extended Release Metadoxine

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, ADD, TOVA, METADOXINE

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

ADHD Unit, Geha MHC, Israel

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Metadoxine SR

Arm Description

Metadoxine is a pyrolate salt of Pyridoxine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00995085

First Posted

October 13, 2009

Last Updated

January 31, 2017

Sponsor

Alcobra Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00995085

Brief Title

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

Official Title

Efficacy Study of Metadoxine SR Formulation in ADHD Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alcobra Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Primary outcome measure is the safety and tolerability of study drug after a single dosing. Additional outcomes include commission error rate from the TOVA test. The result is measured as standard score in % compared to the values of the normal population. Exploratory outcome measures include: TOVA measures like response time , variability, omissions etc. Subtests from Wechsler: digit memory, digit-number signs etc

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit Hyperactivity Disorder

Keywords

ADHD, ADD, TOVA, METADOXINE

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Metadoxine SR

Arm Type

Experimental

Arm Description

Metadoxine is a pyrolate salt of Pyridoxine

Intervention Type

Drug

Intervention Name(s)

Extended Release Metadoxine

Other Intervention Name(s)

Metadoxine, Metadoxil

Intervention Description

one oral 1400mg dose (2 tablets)

Primary Outcome Measure Information:

Title

Safety and Tolerability

Description

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

Time Frame

24 hours after drug adminstration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Iris Manor, MD

Organizational Affiliation

Geha MC, Israel

Official's Role

Principal Investigator

Facility Information:

Facility Name

ADHD Unit, Geha MHC, Israel

City

Petach Tikva

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

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

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