Trial Outcomes & Findings for L-Threonic Acid Magnesium Salt (L-TAMS) in ADHD (NCT NCT02558790)
NCT ID: NCT02558790
Last Updated: 2018-05-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Baseline and 12 Weeks
Results posted on
2018-05-14
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
Treated
|
15
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Screen Fail
|
3
|
Baseline Characteristics
L-Threonic Acid Magnesium Salt (L-TAMS) in ADHD
Baseline characteristics by cohort
| Measure |
L-Threonic Acid Magnesium Salt (L-TAMS)
n=15 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
36.4 years
STANDARD_DEVIATION 14.04 • n=99 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
9 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 WeeksThe 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.
Outcome measures
| Measure |
L-Threonic Acid Magnesium Salt (L-TAMS)
n=15 Participants
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.
|
|---|---|
|
Change in Adult ADHD Investigator Symptom Rating Scale (AISRS) Score
|
-6.3 units on a scale
Standard Deviation 8.8
|
Adverse Events
L-Threonic Acid Magnesium Salt (L-TAMS)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
L-Threonic Acid Magnesium Salt (L-TAMS)
n=15 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Nausea/Vomit/Diarrhea
|
33.3%
5/15 • Number of events 8 • Adverse events were collected for the entire time that subjects were exposed to L-TAMS (12 weeks).
|
|
Musculoskeletal and connective tissue disorders
Muscle Discomfort
|
13.3%
2/15 • Number of events 5 • Adverse events were collected for the entire time that subjects were exposed to L-TAMS (12 weeks).
|
|
Nervous system disorders
Drooling/Sweating
|
6.7%
1/15 • Number of events 1 • Adverse events were collected for the entire time that subjects were exposed to L-TAMS (12 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Cold/Infection/Allergy
|
6.7%
1/15 • Number of events 1 • Adverse events were collected for the entire time that subjects were exposed to L-TAMS (12 weeks).
|
|
General disorders
Headache
|
20.0%
3/15 • Number of events 3 • Adverse events were collected for the entire time that subjects were exposed to L-TAMS (12 weeks).
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
6.7%
1/15 • Number of events 1 • Adverse events were collected for the entire time that subjects were exposed to L-TAMS (12 weeks).
|
|
Psychiatric disorders
Insomnia
|
6.7%
1/15 • Number of events 1 • Adverse events were collected for the entire time that subjects were exposed to L-TAMS (12 weeks).
|
|
Injury, poisoning and procedural complications
Burned Finger
|
6.7%
1/15 • Number of events 1 • Adverse events were collected for the entire time that subjects were exposed to L-TAMS (12 weeks).
|
|
Psychiatric disorders
Decreased Concentration
|
6.7%
1/15 • Number of events 1 • Adverse events were collected for the entire time that subjects were exposed to L-TAMS (12 weeks).
|
|
General disorders
Metallic Taste in Mouth
|
6.7%
1/15 • Number of events 1 • Adverse events were collected for the entire time that subjects were exposed to L-TAMS (12 weeks).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place