Overview

L-Threonic Acid Magnesium Salt (L-TAMS) in ADHD

Status:
Completed
Trial end date:
2017-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Massachusetts General Hospital
Collaborators:
Neurocentria, Inc
Neurocentria, Inc.
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