Trial Outcomes & Findings for Effect of MMFS-202-302 on Cognitive Enhancement in Schizophrenia (NCT NCT02237235)
NCT ID: NCT02237235
Last Updated: 2025-06-22
Results Overview
Change from Baseline in MATRICS Consensus Cognitive Battery (MCCB) working memory domain. The MCCB measures cognitive function. The MCCB provides an overall composite score, expressed as a T-score, with a mean of 50 and a standard deviation of 10 The MCCB does not have minimum and maximum scores due to the use of T scores. A typical score will fall within a range of 40-60. Scores below 40 indicate impaired cognitive functioning, while scores above 60 suggest above-average cognitive abilities. The MCCB is often used in clinical research to assess cognitive deficits in individuals with psychiatric disorders, and the T-score scale is used to track cognitive changes over time.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Baseline to Day 63
Results posted on
2025-06-22
Participant Flow
Participant milestones
| Measure |
MMFS-202 -302
MMFS-202: evening dose
MMFS-302: morning dose
MMFS-202-302: Active ingredient: L-Threonic acid Magnesium salt.
1 g (2 pills) by mouth once daily in the evening for 9 weeks
Drug: MMFS-302 Active ingredient: L-Threonic Acid Magnesium Salt
1 g (2 pills) by mouth once daily in the morning for 9 weeks
|
Placebo
Placebo
Placebo: Two tablets by mouth in the morning, and two tablets by mouth in the evening, daily for 9 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of MMFS-202-302 on Cognitive Enhancement in Schizophrenia
Baseline characteristics by cohort
| Measure |
MMFS-202 -302
n=30 Participants
MMFS-202: evening dose
MMFS-302: morning dose
MMFS-202-302: Active ingredient: L-Threonic acid Magnesium salt.
1 g (2 pills) by mouth once daily in the evening for 9 weeks
Drug: MMFS-302 Active ingredient: L-Threonic Acid Magnesium Salt
1 g (2 pills) by mouth once daily in the morning for 9 weeks
|
Placebo
n=30 Participants
Placebo
Placebo: Two tablets by mouth in the morning, and two tablets by mouth in the evening, daily for 9 weeks.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
60 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Matrics Consensus Cognitive Battery (MCCB)
|
34.8 units on a scale
STANDARD_DEVIATION 12.6 • n=93 Participants
|
30.8 units on a scale
STANDARD_DEVIATION 12.6 • n=4 Participants
|
32.8 units on a scale
STANDARD_DEVIATION 12.6 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 63Change from Baseline in MATRICS Consensus Cognitive Battery (MCCB) working memory domain. The MCCB measures cognitive function. The MCCB provides an overall composite score, expressed as a T-score, with a mean of 50 and a standard deviation of 10 The MCCB does not have minimum and maximum scores due to the use of T scores. A typical score will fall within a range of 40-60. Scores below 40 indicate impaired cognitive functioning, while scores above 60 suggest above-average cognitive abilities. The MCCB is often used in clinical research to assess cognitive deficits in individuals with psychiatric disorders, and the T-score scale is used to track cognitive changes over time.
Outcome measures
| Measure |
MMFS-202 -302
n=30 Participants
MMFS-202: evening dose
MMFS-302: morning dose
MMFS-202-302: Active ingredient: L-Threonic acid Magnesium salt.
1 g (2 pills) by mouth once daily in the evening for 9 weeks
Drug: MMFS-302 Active ingredient: L-Threonic Acid Magnesium Salt
1 g (2 pills) by mouth once daily in the morning for 9 weeks
|
Placebo
n=30 Participants
Placebo
Placebo: Two tablets by mouth in the morning, and two tablets by mouth in the evening, daily for 9 weeks.
|
|---|---|---|
|
MATRICS Consensus Cognitive Battery (MCCB)
|
41.8 units on a scale
Standard Deviation 9.64
|
39.67 units on a scale
Standard Deviation 12.86
|
SECONDARY outcome
Timeframe: Day 63To support the primary endpoint of working memory, the Clinical Global Impression Change (CGI-C) will demonstrate the clinically relevant improvement of global function. Minimum is 1 and Maximum is 6. Higher scores means worse outcome.
Outcome measures
| Measure |
MMFS-202 -302
n=30 Participants
MMFS-202: evening dose
MMFS-302: morning dose
MMFS-202-302: Active ingredient: L-Threonic acid Magnesium salt.
1 g (2 pills) by mouth once daily in the evening for 9 weeks
Drug: MMFS-302 Active ingredient: L-Threonic Acid Magnesium Salt
1 g (2 pills) by mouth once daily in the morning for 9 weeks
|
Placebo
n=30 Participants
Placebo
Placebo: Two tablets by mouth in the morning, and two tablets by mouth in the evening, daily for 9 weeks.
|
|---|---|---|
|
Overall Clinical Global Impression of Severity Improvement Measured by the Clinical Global Impressions Scale Assessment of Change (CGI-C)
|
3.37 score on a scale
Standard Deviation 1.07
|
3.00 score on a scale
Standard Deviation 0.95
|
Adverse Events
MMFS-202 -302
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MMFS-202 -302
n=30 participants at risk
MMFS-202: evening dose
MMFS-302: morning dose
MMFS-202-302: Active ingredient: L-Threonic acid Magnesium salt.
1 g (2 pills) by mouth once daily in the evening for 9 weeks
Drug: MMFS-302 Active ingredient: L-Threonic Acid Magnesium Salt
1 g (2 pills) by mouth once daily in the morning for 9 weeks
|
Placebo
n=30 participants at risk
Placebo
Placebo: Two tablets by mouth in the morning, and two tablets by mouth in the evening, daily for 9 weeks.
|
|---|---|---|
|
Nervous system disorders
Headche
|
16.7%
5/30 • 9 weeks
|
13.3%
4/30 • 9 weeks
|
|
Psychiatric disorders
Insomnia
|
6.7%
2/30 • 9 weeks
|
6.7%
2/30 • 9 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/30 • 9 weeks
|
6.7%
2/30 • 9 weeks
|
|
Psychiatric disorders
pannic attack
|
0.00%
0/30 • 9 weeks
|
3.3%
1/30 • 9 weeks
|
|
Eye disorders
blurred vision
|
0.00%
0/30 • 9 weeks
|
3.3%
1/30 • 9 weeks
|
|
Psychiatric disorders
Exacerbation of Psychosis
|
3.3%
1/30 • 9 weeks
|
0.00%
0/30 • 9 weeks
|
|
Gastrointestinal disorders
Loose Stool
|
3.3%
1/30 • 9 weeks
|
0.00%
0/30 • 9 weeks
|
|
Psychiatric disorders
Cutting Self
|
0.00%
0/30 • 9 weeks
|
3.3%
1/30 • 9 weeks
|
|
Gastrointestinal disorders
Stomach ache
|
3.3%
1/30 • 9 weeks
|
3.3%
1/30 • 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cold symptoms
|
0.00%
0/30 • 9 weeks
|
6.7%
2/30 • 9 weeks
|
|
General disorders
Sore throat
|
0.00%
0/30 • 9 weeks
|
6.7%
2/30 • 9 weeks
|
|
Nervous system disorders
Hand spasm
|
3.3%
1/30 • 9 weeks
|
0.00%
0/30 • 9 weeks
|
|
Endocrine disorders
High triglycerides
|
3.3%
1/30 • 9 weeks
|
0.00%
0/30 • 9 weeks
|
|
Cardiac disorders
Shortness of breath
|
0.00%
0/30 • 9 weeks
|
3.3%
1/30 • 9 weeks
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
3.3%
1/30 • 9 weeks
|
0.00%
0/30 • 9 weeks
|
|
Infections and infestations
Flu-like symptoms
|
3.3%
1/30 • 9 weeks
|
0.00%
0/30 • 9 weeks
|
|
Cardiac disorders
Chest Pressure
|
3.3%
1/30 • 9 weeks
|
0.00%
0/30 • 9 weeks
|
|
Gastrointestinal disorders
Diahrrea
|
3.3%
1/30 • 9 weeks
|
3.3%
1/30 • 9 weeks
|
|
General disorders
Fatigue
|
6.7%
2/30 • 9 weeks
|
0.00%
0/30 • 9 weeks
|
|
Gastrointestinal disorders
Increase in bowel movements
|
0.00%
0/30 • 9 weeks
|
3.3%
1/30 • 9 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.3%
1/30 • 9 weeks
|
0.00%
0/30 • 9 weeks
|
|
General disorders
fever
|
3.3%
1/30 • 9 weeks
|
0.00%
0/30 • 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
3.3%
1/30 • 9 weeks
|
0.00%
0/30 • 9 weeks
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/30 • 9 weeks
|
3.3%
1/30 • 9 weeks
|
|
Musculoskeletal and connective tissue disorders
Strained neck
|
0.00%
0/30 • 9 weeks
|
3.3%
1/30 • 9 weeks
|
|
General disorders
Hospitalization
|
0.00%
0/30 • 9 weeks
|
3.3%
1/30 • 9 weeks
|
|
General disorders
Drowsiness
|
0.00%
0/30 • 9 weeks
|
3.3%
1/30 • 9 weeks
|
|
Endocrine disorders
Hospitalization due to diabetic ketoacidosis
|
3.3%
1/30 • 9 weeks
|
0.00%
0/30 • 9 weeks
|
|
Infections and infestations
strep throat
|
3.3%
1/30 • 9 weeks
|
0.00%
0/30 • 9 weeks
|
|
General disorders
Hot flashes, sweating, chills
|
3.3%
1/30 • 9 weeks
|
0.00%
0/30 • 9 weeks
|
|
Nervous system disorders
Dizziness (Light headedness)
|
0.00%
0/30 • 9 weeks
|
3.3%
1/30 • 9 weeks
|
|
Eye disorders
Pink eye
|
0.00%
0/30 • 9 weeks
|
3.3%
1/30 • 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nose and chest congestion
|
3.3%
1/30 • 9 weeks
|
0.00%
0/30 • 9 weeks
|
|
General disorders
dry mouth
|
3.3%
1/30 • 9 weeks
|
0.00%
0/30 • 9 weeks
|
|
Musculoskeletal and connective tissue disorders
Ingrown toe nail
|
0.00%
0/30 • 9 weeks
|
3.3%
1/30 • 9 weeks
|
|
Gastrointestinal disorders
More burping
|
3.3%
1/30 • 9 weeks
|
0.00%
0/30 • 9 weeks
|
|
Gastrointestinal disorders
Stomach infection
|
0.00%
0/30 • 9 weeks
|
3.3%
1/30 • 9 weeks
|
|
Cardiac disorders
Angioplasty
|
0.00%
0/30 • 9 weeks
|
3.3%
1/30 • 9 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place