ADHD, Attention Deficit/Hyperactivity Disorder
Conditions
Keywords
Attention Deficit/Hyperactivity Disorder, ADHD, Attention Deficit Disorder, ADD, Magnesium
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.
Interventions
DRUGL-Threonic Acid Magnesium Salt (L-TAMS)
Sponsors
Neurocentria, Inc.
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Adult ADHD Investigator Symptom Rating Scale (AISRS) Score | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Screen Fail | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | L-Threonic Acid Magnesium Salt (L-TAMS) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age, Continuous | 36.4 years STANDARD_DEVIATION 14.04 |
| Race/Ethnicity, Customized Asian | 4 Participants |
| Race/Ethnicity, Customized More than one race | 2 Participants |
| Race/Ethnicity, Customized White | 9 Participants |
| Region of Enrollment United States | 15 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 10 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
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.
Time frame: Baseline and 12 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| L-Threonic Acid Magnesium Salt (L-TAMS) | Change in Adult ADHD Investigator Symptom Rating Scale (AISRS) Score | -6.3 units on a scale | Standard Deviation 8.8 |