Clinical trial NCT02558790: L-Threonic Acid Magnesium Salt (L-TAMS) in ADHD
Official title: L-Threonic Acid Magnesium Salt (L-TAMS) in ADHD: An Open-label Pilot Study of Cognitive and Functional Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention Deficit/Hyperactivity Disorder
ADHD
Keywords: Attention Deficit/Hyperactivity Disorder
ADHD
Attention Deficit Disorder
ADD
Magnesium
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Neurocentria, Inc.
First posted: 2015-09-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Change in Adult ADHD Investigator Symptom Rating Scale (AISRS) Score
timeFrame: Baseline and 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Craig Surman, MD
role: PRINCIPAL_INVESTIGATOR
References: