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

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Attention Deficit/Hyperactivity Disorder; ADHD

Treatments: Drug: L-Threonic Acid Magnesium Salt (L-TAMS)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02558790

2014-P-000528

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

L-Threonic Acid Magnesium Salt (L-TAMS)

Experimental group

Description:

Subjects received open label L-Threonic acid Magnesium salt for 12 weeks. Subjects took MMFS202 (6-hour release) and MMFS302 (12-hour release) by mouth each day, up to three times a day.

Treatment:

Drug: L-Threonic Acid Magnesium Salt (L-TAMS)