Trial Outcomes & Findings for Safety and Tolerability of Risperidone Implants (NCT NCT02773576)

NCT ID: NCT02773576

Last Updated: 2020-02-19

Results Overview

The product was sold to another company prior to data analysis. The new company closed before the results were completed, so no results are available for this study.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 140 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2020-02-19

Participant Flow

The product was sold to another company prior to data analysis. The new company closed before the results were completed, so no results are available for this study

Participant milestones

Measure	2x360 mg Risperidone Implant 2, 360 mg risperidone implants Risperidone implant	3x300 mg Risperidone Implant 3, 300 mg risperidone implants Risperidone implant
Overall Study STARTED	0	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Tolerability of Risperidone Implants

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 12 months

Population: The product was sold to another company prior to data analysis. The new company closed before the results were completed, so no results are available for this study.

The product was sold to another company prior to data analysis. The new company closed before the results were completed, so no results are available for this study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: The product was sold to another company prior to data analysis. The new company closed before the results were completed, so no results are available for this study.

The product was sold to another company prior to data analysis. The new company closed before the results were completed, so no results are available for this study.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 12 months

Population: The product was sold to another company prior to data analysis. The new company closed before the results were completed, so no results are available for this study.

The product was sold to another company prior to data analysis. The new company closed before the results were completed, so no results are available for this study.

Outcome measures

Outcome data not reported

Adverse Events

2x360 mg Risperidone Implant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

3x300 mg Risperidone Implant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christine Kampf

Braeburn Inc

Phone: 6104678728

Email: ckampf@braeburnrx.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place