L-Threonic Acid Magnesium Salt (L-TAMS) in ADHD
Condition: Attention Deficit/Hyperactivity Disorder; ADHD
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: L-Threonic Acid Magnesium Salt (L-TAMS)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Attention Deficit/Hyperactivity Disorder; ADHD; Attention Deficit Disorder; ADD; Magnesium

Summary:

      This study is a 12-week, open-label pilot study to test the effects of MMFS-201-301 on
      cognition and function in adults with ADHD. Subjects may enter the trial on a stable dose of
      medication for ADHD, and MMFS-201-301 will be given. Subjects who do not enter on a stable
      dose of ADHD medication will receive MMFS-201-301 alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female adults ages 18-55 years of age

          -  A diagnosis of childhood-onset Attention Deficit/Hyperactivity Disorder (ADHD),
             meeting the Diagnostic and Statistical Manual, Fifth Edition (DSM-V) criteria for ADHD
             in adulthood, including at least 5 current symptoms of inattentive or
             impulsive-hyperactive traits, and childhood onset by age 12, defined as two symptoms
             of inattentive or of impulsive/hyperactive traits by the age of 12

          -  A score of 20 or more on the Adult ADHD Investigator Symptom Report Scale (AISRS),
             and, for those individuals stably treated with stimulants, a Clinical Global
             Impression -ADHD (CGI-ADHD) severity score of no greater than 4 ("moderately ill")

          -  Subjects on a stable dose of stimulant medication must be treated on the same dose for
             at least 1 month prior to study entry

        Exclusion Criteria:

          -  A history of intolerance to magnesium supplementation, or the ingredients in MMFS202
             (6-hour release) AND MMFS302 (12-hour release)

          -  Pregnant or nursing females

          -  A known unstable medical illness including hepatic, renal, gastroenterological,
             respiratory, cardiovascular (including hypertension ≥ 140/90 mmHg at screening),
             endocrinologic (e.g. thyroid), neurologic (e.g. seizure), immunologic, hematologic, or
             psychiatric (other than ADHD) disorder); individuals with kidney dysfunction will be
             excluded, as dysfunctional kidneys may have difficulty clearing the magnesium from the
             body (which can result in dangerously high magnesium levels); individuals with heart
             block will be excluded from the study

          -  Any medical condition that the Principal Investigator (PI) believes will be
             exacerbated by study participation

          -  A history of cancer (except localized skin cancer without metastases or in situ
             cervical cancer) within 5 years prior to screening

          -  A known history of narrow-angle glaucoma

          -  Current (within 3 months) DSM-V criteria for abuse or dependence with any psychoactive
             substance other than nicotine

          -  Intelligence Quotient (IQ) less than 80 (based on the Wechsler Abbreviated Scale of
             Intelligence-II Full Scale IQ calculation)

          -  Multiple adverse drug reactions

          -  Any other concomitant medication with primarily central nervous system activity as
             specified in the study protocol

          -  Current use of a monoamine-oxidase inhibitor (MAOI) or use within the past two weeks

          -  Current use of antibiotics, as the study agent may reduce the absorption of
             antibiotics

          -  Subjects may not take any of the following substances for at least 7 days prior to
             baseline and throughout the study: Calcium channel blockers; any psychoactive
             medications; any medications known to interact with magnesium; supplemental magnesium
             or any magnesium-containing products; all dietary or herbal supplements or products
             including those purported to improve memory, improve sleep, or decrease stress.

          -  Investigator and his/her immediate family; defined as the investigator's spouse,
             parent, child, grandparent, or grandchild