NCT02186769

Brief Summary

A review of the amount of drug in your blood over time.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 schizophrenia

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2014

Completed
27 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

June 18, 2015

Status Verified

June 1, 2015

Enrollment Period

9 months

First QC Date

June 4, 2014

Last Update Submit

June 17, 2015

Conditions

SchizophreniaSchizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

  • Cmax for the Pharmacokinetics (PK) of Risperdal® Consta®

    57 days

Study Arms (2)

Risperdal® Consta®

ACTIVE COMPARATOR

25 Mg or 50 mg

Drug: Risperdal® Consta®

L03004

EXPERIMENTAL

25 mg or 50 mg

Drug: LY03004

Interventions

Risperdal® Consta®DRUG
Risperdal® Consta®
LY03004DRUG
L03004

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients aged 18 to 65 years old;
  • Patients must have a DSM-IV diagnosis of schizophrenia or schizoaffective disorder based on the Mini-International Neuropsychiatric Interview (MINI);
  • Patients must be clinically stable on antipsychotic medications other than risperidone or paliperidone or clozapine for at least 4 weeks prior to screening, based on clinical assessments and a Positive and Negative Syndrome Scale (PANSS) total score less than or equal 70 at screening visit;
  • Patients with a Body Mass Index in range of 18.0 to 35.0;
  • Patients with an Informed consent form signed by the patient or legally acceptable representative

You may not qualify if:

  • Patients with a mental disorders other than schizophrenia or schizoaffective disorder, according to the DSM-IV;
  • Patients who received oral risperidone or paliperidone or clozapine within 14 days prior to screening, or Risperdal® Consta® within 100 days or LY03004 within 80 days prior to screening or paliperidone palmitate within 10 months prior to screening;
  • Patients with neuroleptic malignant syndrome or physical fatigue associated with dehydration or malnutrition;
  • Patients who pose a significant risk of a suicide attempt based on history, investigator's judgment or have answered "yes" on the questions 4 or 5 for current or past 30 days on the Baseline/Screening Version of the Columbia Suicide Severity Rating Scale (C-SSRS).
  • Patients with a history of sensitivity to akathisia and other EPS, especially with previous use of risperidone or paliperidone.
  • Patients with uncontrolled diabetes mellitus as indicated by a HbA1c level greater than or equal 7%;
  • Patients with a history of or currently having epilepsy or convulsion disorders;
  • Patients who have had electroconvulsive therapy within the past 2 months prior to screening;
  • Patients who used medication known to be an inducer or inhibitor for CYP 2D6 less than 2 weeks prior to screening;
  • Patients with a history of allergic reaction to risperidone or to the excipients of LY03004;
  • Patients who have met DSM-IV-TR criteria for substance abuse or dependence with the exception of caffeine or nicotine in the past 6 months prior to screening
  • Patients with a history of clinically relevant cardiac arrhythmia's, cardiovascular disease, thyrotoxicosis, parkinsonism, or hemorrhagic diathesis;
  • Patients who are currently taking medications with primarily CNS activities such as antidepressants, mood stablizers or anticonvulsants;
  • Patients who have participated in a clinical trial of another investigational drug within 30 days prior to screening;
  • Female patients who are pregnant or are breastfeeding or are of childbearing potential without adequate contraception.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Neuropsychiatric Research Center of Orange County

Orange County, California, 92868, United States

Location

Community Clinical Research Inc

Austin, Texas, 78754, United States

Location

Related Publications (1)

  • Wang W, Wang X, Dong Y, Walling DP, Liu P, Liu W, Shi Y, Sun K. Population Pharmacokinetic Analysis to Support and Facilitate Switching from Risperidone Formulations to Rykindo in Patients with Schizophrenia. Neurol Ther. 2024 Apr;13(2):355-372. doi: 10.1007/s40120-024-00578-w. Epub 2024 Jan 20.

    PMID: 38244179DERIVED

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2014

First Posted

July 10, 2014

Study Start

July 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

June 18, 2015

Record last verified: 2015-06

Locations

US(2)