Trial Outcomes & Findings for Pentosan Polysulfate Sodium and Meclofenamic Acid as Treatments in Patients With Psychotic Disorders (NCT NCT02930005)

Results Overview

A higher composite score on the NCTB indicates better cognitive performance. The NCTB consists of 7 tests and 8 sub-scores, and the NIH Toolbox software calculates total composite score by averaging the normalized scores of each subscale and then deriving scale scores. The "NIH Toolbox Scoring and Interpretation Guide" (found online) doesn't indicate a total composite score range (because the score ranges are infinite), but describes scoring as follows: To get a normalized composite score, the score of the test taker is compared to the scores in the NIH Toolbox nationally representative normative sample. The mean score is 100 and the standard deviation (SD) is 15. A score at or near 100 indicates average ability compared with others. Scores around 115 suggest above-average ability. Scores around 130 suggest superior ability (in the top 2 percent nationally). A score around 85 suggests below-average ability. A score in the range of 70 or below suggests significant impairment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

baseline, 8 weeks

Results posted on

2019-03-26

Participant Flow

Participant milestones

Participant milestones
Measure	Meclofenamic Acid 150mg meclofenamic acid daily for 8 weeks Meclofenamic acid	Pentosan Polysulfate Sodium 300mg of pentosan polysulfate sodium daily for 8 weeks Pentosan polysulfate sodium
Overall Study STARTED	2	6
Overall Study Completed 2 Weeks	2	2
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	1	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Meclofenamic Acid 150mg meclofenamic acid daily for 8 weeks Meclofenamic acid	Pentosan Polysulfate Sodium 300mg of pentosan polysulfate sodium daily for 8 weeks Pentosan polysulfate sodium
Overall Study Lost to Follow-up	1	5

Baseline Characteristics

Pentosan Polysulfate Sodium and Meclofenamic Acid as Treatments in Patients With Psychotic Disorders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Meclofenamic Acid n=2 Participants 150mg meclofenamic acid daily for 8 weeks Meclofenamic acid	Pentosan Polysulfate Sodium n=6 Participants 300mg of pentosan polysulfate sodium daily for 8 weeks Pentosan polysulfate sodium	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	20.5 years STANDARD_DEVIATION 3.5 • n=5 Participants	26 years STANDARD_DEVIATION 8.6 • n=7 Participants	24.6 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 8 weeks

A higher composite score on the NCTB indicates better cognitive performance. The NCTB consists of 7 tests and 8 sub-scores, and the NIH Toolbox software calculates total composite score by averaging the normalized scores of each subscale and then deriving scale scores. The "NIH Toolbox Scoring and Interpretation Guide" (found online) doesn't indicate a total composite score range (because the score ranges are infinite), but describes scoring as follows: To get a normalized composite score, the score of the test taker is compared to the scores in the NIH Toolbox nationally representative normative sample. The mean score is 100 and the standard deviation (SD) is 15. A score at or near 100 indicates average ability compared with others. Scores around 115 suggest above-average ability. Scores around 130 suggest superior ability (in the top 2 percent nationally). A score around 85 suggests below-average ability. A score in the range of 70 or below suggests significant impairment.

Outcome measures

Outcome measures
Measure	Meclofenamic Acid n=1 Participants 150mg meclofenamic acid daily for 8 weeks Meclofenamic acid	Pentosan Polysulfate Sodium n=1 Participants 300mg of pentosan polysulfate sodium daily for 8 weeks Pentosan polysulfate sodium
Change in Cognitive Function as Assessed by the NIH Toolbox Cognitive Test Battery (NCTB) Composite Score	31.96 score	0.96 score

SECONDARY outcome

Timeframe: baseline, 8 weeks

Change in the Positive and Negative Syndrome Scale (PANSS) total score after 8 weeks. The range of scores on the PANSS is 30 to 210, with higher scores associated with better outcomes.

Outcome measures

Outcome measures
Measure	Meclofenamic Acid n=1 Participants 150mg meclofenamic acid daily for 8 weeks Meclofenamic acid	Pentosan Polysulfate Sodium n=1 Participants 300mg of pentosan polysulfate sodium daily for 8 weeks Pentosan polysulfate sodium
Change in Severity of Psychotic Symptoms as Assessed by Positive and Negative Syndrome Scale (PANSS)	-11 score	-22 score

Adverse Events

Meclofenamic Acid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pentosan Polysulfate Sodium

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Meclofenamic Acid n=2 participants at risk 150mg meclofenamic acid daily for 8 weeks Meclofenamic acid	Pentosan Polysulfate Sodium n=6 participants at risk 300mg of pentosan polysulfate sodium daily for 8 weeks Pentosan polysulfate sodium
Endocrine disorders Hyperglycemia	0.00% 0/2 • up to 8 weeks	16.7% 1/6 • Number of events 1 • up to 8 weeks

Additional Information

Dr. Olaoluwa O. Okusaga

The University of Texas Health Science Center at Houston

Phone: (713) 741-3952

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place