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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02558790
Recruitment Status : Completed
First Posted : September 24, 2015
Results First Posted : May 14, 2018
Last Update Posted : May 14, 2018
Sponsor:
Collaborator:
Neurocentria, Inc.
Information provided by (Responsible Party):
Craig B. Surman, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE September 23, 2015
First Posted Date  ICMJE September 24, 2015
Results First Submitted Date  ICMJE March 14, 2018
Results First Posted Date  ICMJE May 14, 2018
Last Update Posted Date May 14, 2018
Study Start Date  ICMJE March 2016
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2018)
Change in Adult ADHD Investigator Symptom Rating Scale (AISRS) Score [ Time Frame: Baseline and 12 Weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 23, 2015)
Adult ADHD Investigator Symptom Rating Scale [ Time Frame: 12 Weeks ]
Each of the individual DSM-IV symptoms of ADHD is rated 0 to 3 on a scale of severity.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE L-Threonic Acid Magnesium Salt (L-TAMS) in ADHD
Official Title  ICMJE L-Threonic Acid Magnesium Salt (L-TAMS) in ADHD: An Open-label Pilot Study of Cognitive and Functional Effects
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Attention Deficit/Hyperactivity Disorder
  • ADHD
Intervention  ICMJE Drug: L-Threonic Acid Magnesium Salt (L-TAMS)
Study Arms  ICMJE Experimental: L-Threonic Acid Magnesium Salt (L-TAMS)
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.
Intervention: Drug: L-Threonic Acid Magnesium Salt (L-TAMS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 11, 2018)
20
Original Estimated Enrollment  ICMJE
 (submitted: September 23, 2015)
15
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02558790
Other Study ID Numbers  ICMJE 2014-P-000528
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Craig B. Surman, MD, Massachusetts General Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Massachusetts General Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Neurocentria, Inc.
Investigators  ICMJE
Principal Investigator: Craig Surman, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP