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

ADHD Clinical Trial

Official title:

L-Threonic Acid Magnesium Salt (L-TAMS) in ADHD: An Open-label Pilot Study of Cognitive and Functional Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02558790
• Other study ID #: 2014-P-000528
• Status: Completed
• Phase: Phase 2
• Start date: March 2016
• Est. completion date: October 2017

Study information

• Verified date: April 2018
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity
• Attention Deficit/Hyperactivity Disorder
• Hyperkinesis

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Neurocentria, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Adult ADHD Investigator Symptom Rating Scale (AISRS) Score	The Adult ADHD Investigator Symptom Report Scale (AISRS) assesses each of the 18 individual symptoms of ADHD in DSM-IV on a Likert scale from 0 (not present) to 3 (severe), with a total possible score of 54.; The change in AISRS score from baseline to endpoint (12 weeks) was calculated as the later time point score minus the earlier time point score.	Baseline and 12 Weeks