Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Attention Deficit/Hyperactivity Disorder
ADHD
Intervention Drug: L-Threonic Acid Magnesium Salt (L-TAMS)
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title L-Threonic Acid Magnesium Salt (L-TAMS)
Hide Arm/Group Description Subjects took 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.
Period Title: Overall Study
Started 20 [1]
Treated 15
Completed 13
Not Completed 7
Reason Not Completed
Lost to Follow-up             2
Physician Decision             1
Withdrawal by Subject             1
Screen Fail             3
[1]
20 subjects signed consent to participate in the study. 15 subjects began taking L-TAMS.
Arm/Group Title L-Threonic Acid Magnesium Salt (L-TAMS)
Hide Arm/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.
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
15 participants began taking MMFS-201-301 daily.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
15
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
36.4  (14.04)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
9
  60.0%
Male
6
  40.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Asian
4
  26.7%
White
9
  60.0%
More than one race
2
  13.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
 100.0%
1.Primary Outcome
Title Change in Adult ADHD Investigator Symptom Rating Scale (AISRS) Score
Hide Description

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.

Time Frame Baseline and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title L-Threonic Acid Magnesium Salt (L-TAMS)
Hide Arm/Group Description:
Subjects took 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.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
-6.3  (8.8)
Time Frame Adverse events were collected for the entire time that subjects were exposed to L-TAMS (12 weeks).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title L-Threonic Acid Magnesium Salt (L-TAMS)
Hide Arm/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.
All-Cause Mortality
L-Threonic Acid Magnesium Salt (L-TAMS)
Affected / at Risk (%)
Total   0/15 (0.00%)    
Hide Serious Adverse Events
L-Threonic Acid Magnesium Salt (L-TAMS)
Affected / at Risk (%) # Events
Total   0/15 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
L-Threonic Acid Magnesium Salt (L-TAMS)
Affected / at Risk (%) # Events
Total   10/15 (66.67%)    
Gastrointestinal disorders   
Nausea/Vomit/Diarrhea   5/15 (33.33%)  8
General disorders   
Headache   3/15 (20.00%)  3
Metallic Taste in Mouth   1/15 (6.67%)  1
Injury, poisoning and procedural complications   
Burned Finger   1/15 (6.67%)  1
Musculoskeletal and connective tissue disorders   
Muscle Discomfort   2/15 (13.33%)  5
Nervous system disorders   
Drooling/Sweating   1/15 (6.67%)  1
Psychiatric disorders   
Insomnia   1/15 (6.67%)  1
Decreased Concentration   1/15 (6.67%)  1
Respiratory, thoracic and mediastinal disorders   
Cold/Infection/Allergy   1/15 (6.67%)  1
Skin and subcutaneous tissue disorders   
Dry Skin   1/15 (6.67%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Craig Surman, MD
Organization: Massachusetts General Hospital
Phone: 617-726-8422
EMail: csurman@partners.org
Layout table for additonal information
Responsible Party: Craig B. Surman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02558790    
Other Study ID Numbers: 2014-P-000528
First Submitted: September 23, 2015
First Posted: September 24, 2015
Results First Submitted: March 14, 2018
Results First Posted: May 14, 2018
Last Update Posted: May 14, 2018