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| Name | Class |
|---|---|
| Neurocentria, Inc. | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L-Threonic Acid Magnesium Salt (L-TAMS) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-Threonic Acid Magnesium Salt (L-TAMS) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig Surman, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02144 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | L-Threonic Acid Magnesium Salt (L-TAMS) | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
15 participants began taking MMFS-201-301 daily.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 Weeks |
|
Adverse events were collected for the entire time that subjects were exposed to L-TAMS (12 weeks).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea/Vomit/Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Craig Surman, MD | Massachusetts General Hospital | 617-726-8422 | csurman@partners.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 10, 2017 | Mar 8, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C011369 | threonic acid |
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| Screen Fail |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 10 |
| 15 |
| Muscle Discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Drooling/Sweating | Nervous system disorders | Systematic Assessment |
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| Cold/Infection/Allergy | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Dry Skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Burned Finger | Injury, poisoning and procedural complications | Systematic Assessment |
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| Decreased Concentration | Psychiatric disorders | Systematic Assessment |
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| Metallic Taste in Mouth | General disorders | Systematic Assessment |
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