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

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ClinicalTrials.gov Identifier: NCT00995085
Recruitment Status : Completed
First Posted : October 14, 2009
Results First Posted : July 6, 2011
Last Update Posted : March 13, 2017
Sponsor:
Information provided by (Responsible Party):
Alcobra Ltd.

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: Extended Release Metadoxine Phase 1

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy Study of Metadoxine SR Formulation in ADHD Subjects
Study Start Date : October 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Metadoxine SR
Metadoxine is a pyrolate salt of Pyridoxine
Drug: Extended Release Metadoxine
one oral 1400mg dose (2 tablets)
Other Name: Metadoxine, Metadoxil



Primary Outcome Measures :
  1. Safety and Tolerability [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Alcobra Ltd.
ClinicalTrials.gov Identifier: NCT00995085     History of Changes
Other Study ID Numbers: 0012-09-GEH
First Posted: October 14, 2009    Key Record Dates
Results First Posted: July 6, 2011
Last Update Posted: March 13, 2017
Last Verified: June 2011

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
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Metadoxine
Pyridoxine
Alcohol Deterrents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs