Study Comparing Two Doses of MG01CI and Placebo in Adults With Predominantly Inattentive Attention Deficit Hyperactivity Disorder

NCT01685281 | Completed Phase 2

• 1 other identifier: AL011
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

study objectives are to compare the efficacy, safety and tolerability of two doses of MG01CI (1400 mg and 700 mg) to Placebo for the treatment of symptoms in adults diagnosed with PI-ADHD. subjects will be randomly assigned in a 1:1:1 ratio to one of three treatment sequences as follows:

1. 1.week 1:1400 mg, week 2:700 mg, week 3:placebo
2. 2.week 1:700 mg,week 2: placebo,week 3:1400 mg
3. 3.week 1: placebo, week2:1400 mg, week 3 700 mg

Conditions

ADHD Predominantly Inattentive Type

Keywords

ADHD , Inattention

Outcome Measures

Primary Outcomes (1)

• Change in TOVA ADHD score from Screening/Baseline to 4 hours post-dose;

  TOVA® is a computerized test that provides information about an individual's sustained attention, speed and consistency of responding, and behavioral self-regulation and executive functioning

  4 weeks

Secondary Outcomes (3)

• Change in CANTAB sub-scores from baseline (Visit 2) to 4 hours post-dose;

  4 weeks

• Change in TOVA sub-scores from Screening/Baseline to 4 hours post-dose

  4 weeks

• Number of participants who withdrew early from the study due to AE

  5 weeks

Other Outcomes (1)

• Number of Adverse Events

  5 weeks

Study Arms (3)

Metadoxine (MG01CI) 1400 mg

ACTIVE COMPARATOR

single dose of Metadoxine (MG01CI) 1400 mg

Drug: Metadoxine (MG01CI)

Metadoxine (MG01CI) 700 mg

ACTIVE COMPARATOR

Single dose of Metadoxine (MG01CI) 700 mg

Drug: Metadoxine (MG01CI)

Placebo

PLACEBO COMPARATOR

Single dose of Placebo

Drug: Placebo

Interventions

Metadoxine (MG01CI) DRUG

MG01CI is an orally administered extended release formulation of metadoxine. Doses: 1400 mg and 700 mg and Placebo

Also known as: metadoxil

Metadoxine (MG01CI) 1400 mg; Metadoxine (MG01CI) 700 mg

Placebo DRUG

Placebo tablets will be similar in appearance (color and size) to the investigational product

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult men and women, 18 to 55 years old
• Diagnosed with predominantly inattentive ADHD based on DSM-IV criteria for ADHD as assessed by the Adult ADHD Clinician Diagnostic Scale (ACDS V1.2);
• Clinical severity of at least a moderate level (Clinical Global Impression score of 4 or above)
• TOVA ADHD score of -1.8 or below at Screening /Baseline
• Women with childbearing potential must agree to use effective contraceptive and have negative urine pregnancy test at screening visit
• Able to attend the clinic regularly and reliably
• Able to swallow tablets/capsules
• Able to understand, read, write and speak Hebrew fluently to complete study related materials
• Able to understand and sign written informed consent to participate in the study

You may not qualify if:

• Subjects with ADHD not otherwise specified (NOS) diagnosis
• Subjects with combined type or predominantly hyperactive impulsive ADHD diagnoses
• Subjects with current Axis I diagnosis on SCID
• Subjects with lifetime bipolar or psychosis
• Subjects in treatment for Axis I disorders, even if the disorder is remitted
• Subjects who were non-responders to at least two adequately administered ADHD treatments
• Subjects with any medical or psychiatric condition common diseases such as hypertension, type 2 diabetes mellitus, hyperlipidemia, etc. are allowed per the Investigator's judgment, as long as they are stable and controlled by medical therapy that is constant for at least 8 weeks prior to randomization and throughout the study
• Any prescription or non-prescription ADHD medications during the 14 days (for stimulants) or 28 days (for non-stimulants and other psychotropics) prior to the screening visit
• Known or suspected HIV-positive or with advanced diseases such as AIDS, Hepatitis C, Hepatitis B or tuberculosis
• History of allergy or sensitivity to B complex vitamins
• History or suspicion of PDD, NLD or other psychotic conditions
• Use of Vitamin B throughout the study (either alone or in any multi-vitamin)
• Use of ADHD medications throughout the study
• Use of any psychotropic medications throughout the study
• Use of investigational medication/treatment in the past 30 days prior to the screening visit

Sponsors & Collaborators

• Alcobra Ltd.: lead

Study Sites (1)

Geha Medical Centre

Petah Tikva, Israel

Location

Related Publications (1)

• Manor I, Rubin J, Daniely Y, Adler LA. Attention benefits after a single dose of metadoxine extended release in adults with predominantly inattentive ADHD. Postgrad Med. 2014 Sep;126(5):7-16. doi: 10.3810/pgm.2014.09.2795.

  PMID: 25295645 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

metadoxine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Iris Manor, Dr.

  Geha Medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: September 14, 2012
• Study Start: August 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 14, 2014

Record last verified: 2014-01

Locations

IL (1)