Clinical Efficacy & Safety, of Metadoxine (MG01CI) Extended Release in Attention-Deficit Hyperactivity Disorder (ADHD)
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Intervention: Metadoxine (MG01CI)
Intervention description: MG01CI 1400 mg, that will be taken daily by the patients for a duration of 6 weeks.
Intervention MeSH terms: Metadoxine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: ADHD,Adults,MG01CI,METADOXINE

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
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult males and females, 18 to 50 years old, inclusive, at screening visit

          2. Diagnosed with ADHD based on

               1. DSM-IV criteria for ADHD as assessed by the Adult ADHD Clinician Diagnostic Scale
                  (ACDS V1.2)

               2. SCID clinical interview

          3. Clinical severity of at least a moderate level (Clinical Global Impression score of 4
             or above)

          4. Female subjects with childbearing potential must agree to use effective contraceptive
             and have negative urine pregnancy test at screening visit

          5. Able to attend the clinic regularly and reliably

          6. Able to swallow tablets/capsules

          7. Able to understand, read, write and speak Hebrew fluently to complete study related
             materials

          8. Able to understand and sign written informed consent to participate in the study

        Exclusion Criteria:

          1. Subjects who were non-responder to at least two ADHD treatments

          2. 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

          3. Any prescription or non-prescription ADHD medications during the 7 days prior to the
             screening visit

          4. Known or suspected HIV-positive or with advanced diseases such as AIDS, Hepatitis C,
             Hepatitis B or tuberculosis

          5. History of allergy or sensitivity to B complex vitamins

          6. History or suspicion of PDD, NLD or other psychotic conditions

          7. Use of Vitamin B throughout the study

          8. Use of ADHD medications throughout the study

          9. Use of any psychiatric medications throughout the study

         10. Use of investigational medication/treatment in the past 30 days prior to the screening
             visit per the discretion of the Investigator

         11. 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

         12. 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.

         13. 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.

         14. Blind subjects

         15. Any relation to the Sponsor, Investigator or study staff

         16. 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.

         17. 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

         18. Pregnancy, lactation or inadequate contraceptive method

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