Trial Outcomes & Findings for A 4-week Study of Mifepristone in the Prevention of Risperidone-induced Weight Gain in Healthy Male Volunteers (NCT NCT00698022)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

76 participants

Primary outcome timeframe

Baseline and 28 days

Results posted on

2022-02-08

Participant Flow

Participant milestones

Participant milestones
Measure	Mifepristone Plus Risperidone mifepristone plus risperidone daily	Risperidone Plus Mifepristone-matched Placebo risperidone plus mifepristone-matched placebo daily	Risperidone-matched Placebo Plus Mifepristone risperidone-matched placebo plus mifepristone daily
Overall Study STARTED	30	30	16
Overall Study COMPLETED	14	20	14
Overall Study NOT COMPLETED	16	10	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A 4-week Study of Mifepristone in the Prevention of Risperidone-induced Weight Gain in Healthy Male Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mifepristone Plus Risperidone n=30 Participants mifepristone plus risperidone daily	Risperidone Plus Mifepristone-matched Placebo n=30 Participants risperidone plus mifepristone-matched placebo daily	Risperidone-matched Placebo Plus Mifepristone n=16 Participants risperidone-matched placebo plus mifepristone daily	Total n=76 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	30 Participants n=7 Participants	16 Participants n=5 Participants	76 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	24.6 years STANDARD_DEVIATION 3.9 • n=5 Participants	25.6 years STANDARD_DEVIATION 3.6 • n=7 Participants	24.9 years STANDARD_DEVIATION 4.6 • n=5 Participants	25 years STANDARD_DEVIATION 3.9 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	30 Participants n=7 Participants	16 Participants n=5 Participants	76 Participants n=4 Participants
Region of Enrollment India	30 participants n=5 Participants	30 participants n=7 Participants	16 participants n=5 Participants	76 participants n=4 Participants
Body Weight	57.5 Kilograms STANDARD_DEVIATION 4.1 • n=5 Participants	60.4 Kilograms STANDARD_DEVIATION 4.7 • n=7 Participants	58.2 Kilograms STANDARD_DEVIATION 4.1 • n=5 Participants	58.8 Kilograms STANDARD_DEVIATION 4.5 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline and 28 days

Population: All randomized participants who had at least one post baseline assessment.

Outcome measures

Outcome measures
Measure	Mifepristone Plus Risperidone n=30 Participants mifepristone plus risperidone daily	Risperidone Plus Mifepristone-matched Placebo n=30 Participants risperidone plus mifepristone-matched placebo daily	Risperidone-matched Placebo Plus Mifepristone n=16 Participants risperidone-matched placebo plus mifepristone daily
Change From Baseline in Body Weight	2.32 kilograms Standard Error 0.32	4.23 kilograms Standard Error 0.33	2.87 kilograms Standard Error 0.43

SECONDARY outcome

Timeframe: Baseline and 28 days

Population: All participants who completed the study.

Outcome measures

Outcome measures
Measure	Mifepristone Plus Risperidone n=14 Participants mifepristone plus risperidone daily	Risperidone Plus Mifepristone-matched Placebo n=20 Participants risperidone plus mifepristone-matched placebo daily	Risperidone-matched Placebo Plus Mifepristone n=14 Participants risperidone-matched placebo plus mifepristone daily
Percentage of Participants With <5% and <7% Increase From Baseline in Body Weight <5% increase in body weight	9 Participants	3 Participants	8 Participants
Percentage of Participants With <5% and <7% Increase From Baseline in Body Weight <7% increase in body weight	13 Participants	10 Participants	11 Participants

SECONDARY outcome

Timeframe: Up to 28 days

Population: All participants who received at lease one dose of study drug.

Outcome measures

Outcome measures
Measure	Mifepristone Plus Risperidone n=30 Participants mifepristone plus risperidone daily	Risperidone Plus Mifepristone-matched Placebo n=30 Participants risperidone plus mifepristone-matched placebo daily	Risperidone-matched Placebo Plus Mifepristone n=16 Participants risperidone-matched placebo plus mifepristone daily
Percentage of Participants With One or More Adverse Events	29 Participants	27 Participants	13 Participants

SECONDARY outcome

Timeframe: Up to 28 days

Population: All participants who received at lease one dose of study drug.

Outcome measures

Outcome measures
Measure	Mifepristone Plus Risperidone n=30 Participants mifepristone plus risperidone daily	Risperidone Plus Mifepristone-matched Placebo n=30 Participants risperidone plus mifepristone-matched placebo daily	Risperidone-matched Placebo Plus Mifepristone n=16 Participants risperidone-matched placebo plus mifepristone daily
Percentage of Participants Discontinued From the Study Due to an Adverse Event	5 Participants	4 Participants	1 Participants

Adverse Events

Mifepristone Plus Risperidone

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Risperidone Plus Mifepristone-matched Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Risperidone-matched Placebo Plus Mifepristone

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Mifepristone Plus Risperidone n=30 participants at risk mifepristone plus risperidone daily	Risperidone Plus Mifepristone-matched Placebo n=30 participants at risk risperidone plus mifepristone-matched placebo daily	Risperidone-matched Placebo Plus Mifepristone n=16 participants at risk risperidone-matched placebo plus mifepristone daily
Injury, poisoning and procedural complications suspected snake bite	0.00% 0/30	0.00% 0/30	6.2% 1/16

Other adverse events

Other adverse events
Measure	Mifepristone Plus Risperidone n=30 participants at risk mifepristone plus risperidone daily	Risperidone Plus Mifepristone-matched Placebo n=30 participants at risk risperidone plus mifepristone-matched placebo daily	Risperidone-matched Placebo Plus Mifepristone n=16 participants at risk risperidone-matched placebo plus mifepristone daily
Respiratory, thoracic and mediastinal disorders Nasal Congestion	6.7% 2/30	10.0% 3/30	43.8% 7/16

Additional Information

Robert Roe, MD

Corcept_Therapeutics

Phone: 650-688-8812

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60