Trial Outcomes & Findings for Study in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH)-Risperidone When Risperidone is Administered From a Polyurethane Implant (NCT NCT02658357)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

66 participants

Primary outcome timeframe

6 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

Participant milestones
Measure	600 mg Two, 300 mg Risperidone Implants Risperidone Implant	900 mg Three, 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

Study in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH)-Risperidone When Risperidone is Administered From a Polyurethane Implant

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 6 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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 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.

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.

Outcome measures

Outcome data not reported

Adverse Events

600 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

900 mg

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

Phone: 6104678728

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place