Clinical Efficacy & Safety, of Metadoxine (MG01CI) Extended Release in Attention-Deficit Hyperactivity Disorder (ADHD)

NCT01243242 | Completed Phase 2 Results

• 1 other identifier: AL008
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate efficacy, safety and tolerability of metadoxine (MG01CI) extended release formulation for the treatment of adults diagnosed with ADHD

Conditions

ADHD

Keywords

ADHD,Adults,MG01CI,METADOXINE

Outcome Measures

Primary Outcomes (1)

• Conners' Adult ADHD Rating Scales (CAARS™)

  The primary efficacy endpoint is the difference in change (decrease) in CAARS (Total ADHD Symptoms Score) between the study groups. The CAARS assess the presence and severity of ADHD symptoms and behaviors in adults. Respondents are asked to report their own experiences by rating items pertaining to their behavior/problems using a 4-point Likert-style format ranging from 0 ('Not at all', 'never') to 3 ('Very much', 'very frequently'). The scale measures ADHD symptoms using a 30-item questionnaire.Total score is the sum of all the items ,min=30 Max=90

  6 weeks (from visit 1 baseline to visit 6)

Secondary Outcomes (3)

• Test of Variables of Attention (TOVA) (Change in ADHD Score From Screening to Visit 6)

  6 weeks( visit 1 baseline to visit 6)

• Adult ADHD Quality of Life (AAQoL)- Measuring Change in Total Score of AAQoL From Visit 1 to Visit 6

  6 weeks (from visit 1 baseline to visit 6)

• Clinical Global Impression Scale (CGI-I)Score

  6 weeks from visit 1 baseline to visit 6

Study Arms (2)

METADOXINE

EXPERIMENTAL

Eligible subjects will be randomly assigned to receive MG01CI (1,400 mg)

Drug: Metadoxine (MG01CI)

Placebo

PLACEBO COMPARATOR

Eligible subjects will be randomly assigned to receive Placebo (1,400 mg)

Drug: Metadoxine (MG01CI)

Interventions

Metadoxine (MG01CI) DRUG

MG01CI 1400 mg, that will be taken daily by the patients for a duration of 6 weeks.

Also known as: Metadoxil

METADOXINE; Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult males and females, 18 to 50 years old, inclusive, at screening visit
• Diagnosed with ADHD based on
• DSM-IV criteria for ADHD as assessed by the Adult ADHD Clinician Diagnostic Scale (ACDS V1.2)
• SCID clinical interview
• Clinical severity of at least a moderate level (Clinical Global Impression score of 4 or above)
• Female subjects 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 who were non-responder to at least two ADHD treatments
• Subjects with any medical or psychiatric condition (e.g. schizophrenia, personality disorder as diagnosed by DSM-IV) or clinical significant or unstable medical or surgical condition that may preclude safe and complete study participation as determined by medical history, physical examination, neurological exam, laboratory tests or ECG or based on the opinion of the Investigator; 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 7 days 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
• Use of ADHD medications throughout the study
• Use of any psychiatric medications throughout the study
• Use of investigational medication/treatment in the past 30 days prior to the screening visit per the discretion of the Investigator
• Use of any medication or food supplement not considered acceptable by the clinical Investigator or the medical monitor during the 14-day period before randomization
• Current (or history within the last 6 months) of drug dependence or substance abuse disorder according to DSM-IV-TR criteria (excluding nicotine). Subjects should also agree to refrain from consuming abnormally high amounts of caffeine during the study.
• Suicidality, defined as either active suicidal plan/intent or active suicidal thoughts, in the 6 months before the Screening Visit or no lifetime suicide attempt.
• Blind subjects
• Any relation to the Sponsor, Investigator or study staff

Sponsors & Collaborators

• Alcobra Ltd.: lead

Study Sites (2)

Cognitive Neurology unit Rambam Health Care Campus

Haifa, Israel

Location

ADHD Unit, Geha Mental Health Center

Petah Tikva, Israel

Location

Related Publications (2)

• Manor I, Newcorn JH, Faraone SV, Adler LA. Efficacy of metadoxine extended release in patients with predominantly inattentive subtype attention-deficit/hyperactivity disorder. Postgrad Med. 2013 Jul;125(4):181-90. doi: 10.3810/pgm.2013.07.2689.

  PMID: 23933905 DERIVED

• Manor I, Ben-Hayun R, Aharon-Peretz J, Salomy D, Weizman A, Daniely Y, Megiddo D, Newcorn JH, Biederman J, Adler LA. A randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy, safety, and tolerability of extended-release metadoxine in adults with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2012 Dec;73(12):1517-23. doi: 10.4088/JCP.12m07767.

  PMID: 23290324 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

metadoxine

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr Yaron Daniely CEO
• Organization: Alcobra

yaron@alcobra-pharma.com

972-072-2204662

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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: November 18, 2010
• Study Start: February 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2011
• Last Updated: April 20, 2012
• Results First Posted: April 18, 2012

Record last verified: 2012-04

Locations

IL (2)