AzTrials
AzTrials

ADHD Predominantly Inattentive TypePhase 2NCT01685281

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

A Phase 2 study testing Metadoxine (MG01CI) in people with ADHD Predominantly Inattentive Type, run by Alcobra Ltd. at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
ADHD Predominantly Inattentive Type
What is being tested?
Metadoxine (MG01CI)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteIsrael
Study dates
Aug 2013to Dec 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 23Show fewer
  • 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
  • Use of any medication or food supplement unless cleared by 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 significantly changing consumption of caffeine during the study.
  • Suicidality, defined as active ideation, intent or plan, or any lifetime attempt (CSSRS)
  • Subjects who cannot complete any study instruments or questionnaires
  • Any relation to the Sponsor, Investigator or study staff
  • Any condition, which in the opinion of the Principal Investigator would place the subject at risk or influence the conduct of the study or interpretation of results, including (but not limited to) abnormally low intellectual capacity.
  • Subjects who cannot fully comprehend the implications of the protocol or comply with its requirements or are capable to follow the study schedule for any reason
  • Women of childbearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test and agree to use a reliable method of birth control (e.g., oral contraceptives or Norplant®; a reliable barrier method of birth control [diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam]; intrauterine devices; partner with vasectomy; or abstinence) during the study. Note that this inclusion criterion applies only to females of childbearing potential. Females of childbearing potential are defined as women not surgically sterilized and between menarche and 2 years post-menopause

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Geha Medical Centre

    Petah Tikva

Other trials in Israel

About this study

Official title: Randomized, Double-blind, Single-center, Dose-finding Study Designed to Compare Two Doses of MG01CI (Metadoxine Extended Release) and Placebo in Adults With Predominantly Inattentive Attention Deficit Hyperactivity Disorder

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

The study will consist of three periods: a screening period of up to one week, a 3-week double-blind treatment period, and a one-week safety follow-up period.

Read the detailed description

The purpose of this dose finding study is to compare two doses of MG01CI (1400 mg and 700 mg) to Placebo, in adult subjects with PI-ADHD. A crossover study design will allow evaluation of safety/tolerability and efficacy using validated computerized tests.

subjects will be randomly assigned in a 1:1:1 ratio to one of three treatment sequences as follows:

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

Overview of Study Visits

Screening Period:

Visit 1 - Screening/Baseline Visit (up to 7 days prior to dosing)

Treatment Period:

Visit 2 - Day 0 (Randomization Visit) Visit 3 - Day 7 ± 3 days Visit 4 - Day 14 ± 3 days Visit 5 - Day 21 ± 3 days

Follow-up period:

Visit 6 - Day 28 ± 3 days

Study duration for each subject will be up to 35 days .

Being tested
Metadoxine (MG01CI), Placebo
Keywords
ADHD , Inattention
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Metadoxine (MG01CI)Drug

    Also called metadoxil

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

  • PlaceboDrug

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

Study groups in NCT01685281
Study groupRoleWhat they receive
Metadoxine (MG01CI) 1400 mgActive comparatorsingle dose of Metadoxine (MG01CI) 1400 mg
Receives: Drug: Metadoxine (MG01CI)
Metadoxine (MG01CI) 700 mgActive comparatorSingle dose of Metadoxine (MG01CI) 700 mg
Receives: Drug: Metadoxine (MG01CI)
PlaceboPlacebo comparatorSingle dose of Placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 4 weeks

Secondary outcomes (3)

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

    The CANTAB is a computerized test assessing the key cognitive deficits present in ADHD. Sub-scores will include spatial working memory (SWM), stop signal task (SST), rapid visual information processing (RVP), and reaction time (RTI).

    Measured: 4 weeks

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

    Measured: 4 weeks

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

    Measured: 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2012 (estimated)
  2. Study startAug 2013
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01685281
Sponsor's protocol ID
AL011
Status last verified
Jan 2014
First submitted
12 Sep 2012
Last updated
14 Jan 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 25295645

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Metadoxine (MG01CI) in people with ADHD Predominantly Inattentive Type, run by Alcobra Ltd. at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in TOVA ADHD score from Screening/Baseline to 4 hours post-dose; (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01685281, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in