Clinical trial NCT02059642 (phase 2/phase 3, status: completed)
Conditions: adhd, attention-deficit/hyperactivity disorder, predominantly inattentive type
ICD codes: F90.0
Drugs: mg01ci (1400 mg), placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Subject is a man or a non-pregnant, non-lactating woman 18 to 55 years of age,
             inclusive, at the Screening Visit.

          -  Subject has a diagnosis of ADHD based on criteria in the Diagnostic and Statistical
             Manual of Mental Disorders, Fourth Edition (DSM-IV) and DSM5.

          -  Subject has ADHD with at least moderate clinical severity (Clinical Global
             Impression-Severity [CGI-S]) score of 4 or greater).

          -  Subject has a score on the total ADHD symptom score with adult prompts of the
             CAARS-Inv of at least 22.

          -  Female subjects of childbearing potential must agree to use an effective contraceptive
             throughout the study

          -  Subject is able to attend the clinic regularly and reliably.

          -  Subject is able to swallow tablets and capsules.

          -  Subject is able to understand, read, write, and speak English fluently to complete the
             study-related materials (or Hebrew for Israeli subjects).

          -  Subject is able to understand and sign an informed consent form to participate in the
             study.

        Exclusion Criteria:

          -  Subject did not respond in the past to 2 adequate trials of stimulant treatments or 1
             adequate trial of atomoxetine treatment (in the investigator's judgment).

          -  Subject has any psychiatric condition clinically significant or unstable medical or
             surgical condition that may preclude safe and complete study participation as
             determined by the investigator .

          -  Subject has a known or suspected human immune deficiency virus-positive status or has
             diseases such as acquired immunodeficiency disorder, hepatitis C, hepatitis B, or
             tuberculosis.

          -  Subject has a history of an allergy or sensitivity to B-complex vitamins.

          -  Subject has a history of intellectual disability or a history or suspicion of autism
             spectrum disorder.

          -  Subject has a current Axis I diagnosis (other than ADHD) according to the Structured
             Clinical Interview for DSM IV Axis I Disorders (SCID) or has a lifetime history of
             bipolar disorder or psychosis.

          -  Subject has used mega-dose vitamin B6/pyridoxine during the 28 days before the
             Screening Visit.

          -  Subject has used high-dose supplements of omega-3 fatty acids ≥ 500 mg on at least 1
             day or folic acid supplements during the 2 weeks before the Screening Visit.

          -  Subject has used an investigational medication/treatment in the 30 days before the
             Screening Visit

          -  Subject has used any medication or food supplement that the investigator or the
             medical monitor considers unacceptable during the 14-day period before randomization.

          -  Subject has a current drug or alcohol dependence or substance abuse disorder according
             to DSM-IV. Subject should also agree to keep their caffeine intake consistent and
             refrain from consuming ≥300 mg per day of caffeine (no more than three 8-ounce
             servings of coffee) during the study.

          -  Subject has suicidality, defined as active ideation, an intent or plan, or any
             significant lifetime suicidal behavior. Subjects exhibiting history (within previous
             12 months) of non-suicidal self-injurious behavior will be excluded.

          -  Subject has taken any prescription or non-prescription ADHD medications during the 14
             days (for all psychotropic medications other than fluoxetine) or 28 days (for
             fluoxetine) before the randomization visit.

          -  Subject is significantly visually impaired to an extent that is not able to be
             corrected by prescription glasses or contact lenses

          -  Subject is related to the sponsor, investigator, or study staff.

          -  Subject has any condition that, in the principal investigator's opinion, would place
             the subject at risk or influence the conduct of the study or interpretation of
             results,

          -  Subject cannot fully comprehend the implications of the protocol, cannot comply with
             its requirements, or is incapable of following the study schedule for any reason.

          -  Subject is pregnant, lactating, or using an inadequate contraceptive method.

          -  If there is a ≥25% change in the CAARS-Inv results between the Interim visit (off
             drug) assessment and the Baseline assessment, or if the subject does not return for
             the Baseline CAARS-Inv assessment, the subject will not be randomized. For subjects
             not needing washout, if there is a ≥25% change in the CAARS-Inv results between the
             Screening Visit assessment and the Baseline assessment, or if the subject does not
             return for the Baseline CAARS-Inv assessment, the subject will not be randomized.