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

• Sponsor: Braeburn Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02658357
• Collaborator: (none)
• Enrollment: 66
• Location: 1
• Arms: 2
• Actual Duration (Months): 22
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

The study will be a 6-month, open-label, multiple center study in approximately 50 stable subjects diagnosed with schizophrenia or schizoaffective disorder to evaluate the safety, tolerability, and pharmacokinetics of Risperidone and 9-OH-Risperidone following implantation of two or three, 300 mg Risperidone Implants.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia; Schizo-affective Disorder	Drug: Risperidone Implant	Phase 2

Detailed Description

The study will be a 6-month, open-label, study in approximately 50 stable subjects diagnosed with schizophrenia or schizoaffective disorder to evaluate the safety, tolerability, and pharmacokinetics of Risperidone and 9-OH-Risperidone following implantation of two or three, 300 mg Risperidone Implants.

Subjects who are diagnosed with schizophrenia or schizoaffective disorder according to DSM-V and are stable on a daily 4 mg oral dose of Risperidone for at least 8 weeks will be recruited into the study.

Subjects stable on a 4 mg oral dose of Risperidone will be implanted with two or three, 300 mg, Risperidone Implants. All implants will be placed in the inner aspect of the upper arm. Plasma concentrations of Risperidone and the active moiety will be measured prior to placement of the Risperidone Implants, throughout the implantation period, and after re-converting to oral Risperidone following the removal of the Risperidone Implants.

Study Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Study in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH)-Risperidone When Risperidone is Administered From a Polyurethane Implant
• Actual Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: Aug 1, 2017
• Actual Study Completion Date: Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 600 mg Two, 300 mg Risperidone Implants	Drug: Risperidone Implant
Experimental: 900 mg Three, 300 mg Risperidone Implants	Drug: Risperidone Implant

Outcome Measures

Primary Outcome Measures

1. Area Under the Curve (AUC) for Active Moiety, 9-hydroxy-risperidone and Risperidone [6 months]

2. Cmax for Active Moiety, 9-hydroxy-risperidone and Risperidone [6 months]

Secondary Outcome Measures

1. Safety and Efficacy of a Risperidone Implant as Assessed by the Positive and Negative Syndrome Scale (PANSS) [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject (and/or a subject's authorized legal representative) has provided written informed consent

2. Patient meets the following criteria:

• Outpatient status

• PANSS Total Score ≤ 80 at screening and if PANSS score at baseline is ≥ 20% change from screening, the patients cannot participate in the study.

• A score of ≤ 3 on the following PANSS items:

• Conceptual disorganization

• Suspiciousness

• Hallucinatory behavior

• Unusual thought content

1. Subject is male or female between 18 to 60 years of age

2. Subject has a diagnosis of schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria

Exclusion Criteria:

1. Hospitalized or required acute crisis intervention for symptom exacerbation in the 60 days prior to admission as determined by the Investigator

2. Subject has a history of suicide attempt in the last year, or in the opinion of the investigator is currently at imminent risk of suicide

3. Has a current or recent (within 12 months) DSM-V diagnosis of moderate or severe substance use disorder (except for tobacco use disorder) or has a positive urine drug screen for prohibited substances at screening.

4. Have impaired hepatic (ALT/AST >1.5 times higher than the upper limit of normal) or renal function (eGFR<50 mL/min)

5. Previously defined hypersensitivity to Risperidone

6. History of neuromalignant syndrome (NMS)

7. Electroconvulsive therapy within 6 months of admission

8. Requires current use of agents that are strong inhibitors and inducers of cytochrome P450 2D6

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Segal Institute for Clinical Research 1201 North 37th Avenue	Hollywood	Florida	United States	33021

Sponsors and Collaborators

• Braeburn Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 12, 2017

More Information

Publications

None provided.

• Responsible Party: Braeburn Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02658357
• Other Study ID Numbers: BB-PK-103
• First Posted: Jan 18, 2016
• Last Update Posted: Feb 19, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Schizophrenia; Mood Disorders; Psychotic Disorders; Risperidone

Study Results

Participant Flow

Pre-assignment Detail	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

Arm/Group Title	600 mg	900 mg
Arm/Group Description	Two, 300 mg Risperidone Implants Risperidone Implant	Three, 300 mg Risperidone Implants Risperidone Implant
Period Title: Overall Study
STARTED	0	0
COMPLETED	0	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	600 mg	900 mg	Total
Arm/Group Description	Two, 300 mg Risperidone Implants Risperidone Implant	Three, 300 mg Risperidone Implants Risperidone Implant	Total of all reporting groups
Overall Participants	0	0	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Age () []
Sex: Female, Male () []
Female
Male
Race (NIH/OMB) () []
American Indian or Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More than one race
Unknown or Not Reported
Region of Enrollment (participants) []

Outcome Measures

1. Primary Outcome

Title	Area Under the Curve (AUC) for Active Moiety, 9-hydroxy-risperidone and Risperidone
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	600 mg	900 mg
Arm/Group Description	Two, 300 mg Risperidone Implants Risperidone Implant	Three, 300 mg Risperidone Implants Risperidone Implant
Measure Participants	0	0

2. Primary Outcome

Title	Cmax for Active Moiety, 9-hydroxy-risperidone and Risperidone
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	600 mg	900 mg
Arm/Group Description	Two, 300 mg Risperidone Implants Risperidone Implant	Three, 300 mg Risperidone Implants Risperidone Implant
Measure Participants	0	0

3. Secondary Outcome

Title	Safety and Efficacy of a Risperidone Implant as Assessed by the Positive and Negative Syndrome Scale (PANSS)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	600 mg	900 mg
Arm/Group Description	Two, 300 mg Risperidone Implants Risperidone Implant	Three, 300 mg Risperidone Implants Risperidone Implant
Measure Participants	0	0

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	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.
Arm/Group Title	600 mg		900 mg
Arm/Group Description	Two, 300 mg Risperidone Implants Risperidone Implant		Three, 300 mg Risperidone Implants Risperidone Implant
All Cause Mortality
	600 mg		900 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	600 mg		900 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	600 mg		900 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.