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

Completed · Phase 2

Conditions studied: Attention Deficit/Hyperactivity Disorder, ADHD

In brief

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.

Key facts

Study ID

NCT02558790

Run by

Massachusetts General Hospital

People needed

20

Starts

2016-03-01

Expected to finish

2017-10-01

Last updated by the study team

2018-05-14

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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