L-Threonic Acid Magnesium Salt (L-TAMS) in ADHD
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|ClinicalTrials.gov Identifier: NCT02558790|
Recruitment Status : Completed
First Posted : September 24, 2015
Results First Posted : May 14, 2018
Last Update Posted : May 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit/Hyperactivity Disorder ADHD||Drug: L-Threonic Acid Magnesium Salt (L-TAMS)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||L-Threonic Acid Magnesium Salt (L-TAMS) in ADHD: An Open-label Pilot Study of Cognitive and Functional Effects|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||October 2017|
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.
Drug: L-Threonic Acid Magnesium Salt (L-TAMS)
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02558790
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02144|
|Principal Investigator:||Craig Surman, MD||Massachusetts General Hospital|