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ADHDPhase 2NCT01243242

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

A Phase 2 study testing Metadoxine (MG01CI) in people with ADHD, run by Alcobra Ltd. at 2 sites in Israel.

Completed

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

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
ADHD
What is being tested?
Metadoxine (MG01CI)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
2 sitesIsrael
Study dates
Feb 2011to Sep 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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
  • 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
  • Pregnancy, lactation or inadequate contraceptive method
  • -

Trial locations and contacts

2 sites in 1 country.

Israel2 sites

  • Cognitive Neurology unit Rambam Health Care Campus

    Haifa

  • ADHD Unit, Geha Mental Health Center

    Petah Tikva

Other trials in Israel

About this study

Official title: Randomized, Double-blind, Placebo-controlled, Multi-center Study Designed to Evaluate the Efficacy, Safety and Tolerability of Metadoxine Extended Release in Adults With Attention Deficit Hyperactive Disorder

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

Read the detailed description

This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with ADHD.

Eligible subjects will be randomly assigned in a 1:1 ratio to one of two treatment groups, 1400 mg Metadoxine (MG01CI) and Placebo. The study will consist of three periods: a screening period of up to 2 weeks, a 6-week double-blind treatment period, and a 2-week safety follow-up period. The total duration of subject participation will be ~10 weeks.

Overview of Study Visits

Screening Period:

Visit 1 - Screening/Baseline Visit (up to 14 days prior to dosing)

Treatment Period:

Visit 2 - Day 0 (Randomization Visit) Visit 3 - Day 7 ± 2 days Visit 4 - Day 14 ± 2 days Visit 5 - Day 28 ± 2 days Visit 6 - Day 42 ± 2 days

Follow-up period:

Visit 7 - Day 56 ± 3 days

Conditions
ADHD
Being tested
Metadoxine (MG01CI)
Keywords
ADHD,Adults,MG01CI,METADOXINE
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 1400 mg, that will be taken daily by the patients for a duration of 6 weeks.

Study groups in NCT01243242
Study groupRoleWhat they receive
METADOXINEExperimentalEligible subjects will be randomly assigned to receive MG01CI (1,400 mg)
Receives: Drug: Metadoxine (MG01CI)
PlaceboPlacebo comparatorEligible subjects will be randomly assigned to receive Placebo (1,400 mg)
Receives: Drug: Metadoxine (MG01CI)

What is being measured

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

  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

    Measured: 6 weeks (from visit 1 baseline to visit 6)

Secondary outcomes (3)

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

    The 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. ADHD score is a comparison of the subject's response to the CPT test to those of an ADHD group, and is reported as a Z-score. An ADHD score of -1.80 and less fits the profile of the ADHD sample. A score of more than -1.80 (more positive) does not fit the ADHD profile. When comparing ADHD scores the higher the ADHD score the better the performance.

    Measured: 6 weeks( visit 1 baseline to visit 6)

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

    The AAQoL scale provides a validated disease-specific measure of the impact of ADHD on quality of life.It is scored as an overall score (29 items) and four subscale scores: life productivity (11 items), psychological health (6 items), life outlook (7 items) and relationships (5 items). Individual items are scored on a five-point Likert-like scale from 'Not at all/Never' (1) to 'Extremely/Very Often' (5).

    Measured: 6 weeks (from visit 1 baseline to visit 6)

  3. Clinical Global Impression Scale (CGI-I)Score

    The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI-I scores range from 1 ('very much improved') through to 7 ('very much worse').

    During the conduct of the study, CGI-I evaluations were not done correctly and thus data interpretation is limited.

    Measured: 6 weeks from visit 1 baseline to visit 6

Timeline

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

  1. First posted18 Nov 2010 (estimated)
  2. Study startFeb 2011
  3. Primary completionAug 2011
  4. Study completionSep 2011

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
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01243242
Sponsor's protocol ID
AL008
Status last verified
Apr 2012
First submitted
17 Nov 2010
Last updated
20 Apr 2012
Data monitoring committee
No

Publications

  • 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.

    PubMed 23933905

  • 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.

    PubMed 23290324

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Metadoxine (MG01CI) in people with ADHD, run by Alcobra Ltd. at 2 sites 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 10 inclusion and 19 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 20 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 18 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Conners' Adult ADHD Rating Scales (CAARS™) (time frame: 6 weeks (from visit 1 baseline to visit 6)). 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 NCT01243242, which also lists 2 linked publications.

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 20 Apr 2012.

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