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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcobra Ltd.
ClinicalTrials.gov Identifier:
NCT00995085
First received: October 13, 2009
Last updated: April 27, 2014
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: Extended Release Metadoxine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy Study of Metadoxine SR Formulation in ADHD Subjects

Resource links provided by NLM:


Further study details as provided by Alcobra Ltd.:

Primary Outcome Measures:
  • Safety and Tolerability [ Time Frame: 24 hours after drug adminstration ] [ Designated as safety issue: Yes ]
    Subjects were evaluated for general safety and tolerablity measures, including number of AEs and AEs related (possibly or likely) to study drug


Enrollment: 43
Study Start Date: October 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metadoxine SR
Metadoxine is a pyrolate salt of Pyridoxine
Drug: Extended Release Metadoxine
one oral 1400mg dose (2 tablets)
Other Name: Metadoxine, Metadoxil

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:

  1. TOVA measures like response time , variability, omissions etc.
  2. Subtests from Wechsler: digit memory, digit-number signs etc
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00995085

Locations
Israel
ADHD Unit, Geha MHC, Israel
Petach Tikva, Israel
Sponsors and Collaborators
Alcobra Ltd.
Investigators
Principal Investigator: Iris Manor, MD Geha MC, Israel
  More Information

No publications provided

Responsible Party: Alcobra Ltd.
ClinicalTrials.gov Identifier: NCT00995085     History of Changes
Other Study ID Numbers: 0012-09-GEH
Study First Received: October 13, 2009
Results First Received: December 27, 2010
Last Updated: April 27, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Alcobra Ltd.:
ADHD
ADD
TOVA
METADOXINE

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Metadoxine
Pyridoxine
Alcohol Deterrents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 20, 2014