L-Threonic Acid Magnesium Salt (L-TAMS) in ADHD
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| ClinicalTrials.gov Identifier: NCT02558790 |
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Recruitment Status :
Completed
First Posted : September 24, 2015
Results First Posted : May 14, 2018
Last Update Posted : May 14, 2018
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Sponsor:
Massachusetts General Hospital
Collaborator:
Neurocentria, Inc.
Information provided by (Responsible Party):
Craig B. Surman, MD, Massachusetts General Hospital
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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.
| 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) |
| Primary Purpose: | Treatment |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: L-Threonic Acid Magnesium Salt (L-TAMS) |
Primary Outcome Measures :
- 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.
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| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
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
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02144 | |
Sponsors and Collaborators
Massachusetts General Hospital
Neurocentria, Inc.
Investigators
| Principal Investigator: | Craig Surman, MD | Massachusetts General Hospital |
Study Documents (Full-Text)
Documents provided by Craig B. Surman, MD, Massachusetts General Hospital:
Documents provided by Craig B. Surman, MD, Massachusetts General Hospital:
Study Protocol and Statistical Analysis Plan [PDF] May 10, 2017
| Responsible Party: | Craig B. Surman, MD, Scientific Coordinator of the Adult ADHD Program, Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT02558790 History of Changes |
| Other Study ID Numbers: |
2014-P-000528 |
| First Posted: | September 24, 2015 Key Record Dates |
| Results First Posted: | May 14, 2018 |
| Last Update Posted: | May 14, 2018 |
| Last Verified: | April 2018 |
Keywords provided by Craig B. Surman, MD, Massachusetts General Hospital:
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Attention Deficit/Hyperactivity Disorder ADHD Attention Deficit Disorder ADD Magnesium |
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Neurodevelopmental Disorders Mental Disorders |
Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms |