Equivalence of Generic Clozapine to Orally Dissolving Clozapine in Schizophrenia or Schizoaffective Disorder

April 14, 2015 updated by: Jean-Pierre Lindenmayer, Manhattan Psychiatric Center

An Open-Label Study Changing Generic Clozapine Formulation to FazaClo® (Clozapine, USP) Orally Disintegrating Tablets in Stable Patients With Schizophrenia or Schizoaffective Disorder

The purpose of this study is to obtain data on equivalence of generic clozapine to Fazaclo (orally disintegrating tablet). Generic clozapine is the most frequently used clozapine and such data is important for clinicians to have.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study is to determine the equivalence of generic clozapine tablets to FazaClo in patients with schizophrenia or schizoaffective disorder who are already taking generic clozapine and are switched to FazaClo.

In this study, patients receiving a stable twice-daily dose of generic clozapine formulation for the past one month will be switched to FazaClo. A trough steady-state clozapine and desmethylclozapine concentrations will be taken thrice while patient is on generic Clozapine. After the third clozapine level patients will be switched from their generic clozapine formulation to FazaClo, at the same dosage and treatment regimen as the generic clozapine formulation they had been receiving. Trough steady-state clozapine and desmethylclozapine concentration levels will be taken twice, 7 days and 14 days after starting Fazaclo.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10027
        • Manhattan Psychiatric Center, 125th Street, Out Patient Clinic
      • New York, New York, United States, 10035
        • Manhattan Psychiatric Center, Inpatient Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients (male or female) are between 18 and 59 years of age.
  • Female patients are not pregnant or breastfeeding and those who are not surgically sterilized, postmenopausal (at least six months), or sexually abstinent are using adequate contraceptive methods (defined as diaphragm, condom, foam/jellies, sponge, and/or oral contraceptives).
  • Patients have a diagnosis of 1) treatment-resistant schizophrenia or; 2) schizophrenia, chronic (all types) and in a residual phase or in remission, or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria and are judged to be at chronic risk for reexperiencing suicidal behavior based on history and recent clinical state. In addition, all patients must have a total score on the PANSS of 90 or less.
  • Patients have been on a generic clozapine formulation for one month prior to Visit 1 with no changes in clozapine or psychotropic medication dosage in the past one month. Clozapine dose is administered twice daily.
  • Patients have no clinically significant abnormalities in the medical history, physical examination, and clinical laboratory tests.
  • Patients have given written consent after being advised of the nature and risks of the study and are competent to sign an Informed Consent Form.
  • Patients who have shown inconsistent clozapine plasma levels or inconsistent clinical response with a therapeutically adequate daily dose of clozapine as documented in the medical chart or documented by nursing notes about patients' cheeking the oral tablets of clozapine for at least 6 months.

Exclusion Criteria:

  • Patients are included in the National Non-Rechallenge Master File for Clozaril.
  • Patients have a medical or surgical condition that might interfere with the absorption, metabolism, or excretion of clozapine or FazaClo.
  • Patients have a history of granulocytopenia or myeloproliferative disorder, either drug-induced or idiopathic.
  • Patients have a total white blood cell (WBC) count below 4000/mm3 or an absolute neutrophil count (ANC) below 2000/mm3.
  • Patients have a history of clinically significant cardiovascular, renal, hepatic, respiratory, endocrine (except noninsulin-dependent diabetes mellitus), or gastrointestinal disease.
  • Patients have a known history of human immunodeficiency virus infection.
  • Patients have a history of epilepsy or seizures or are comatose or experiencing severe central nervous system depression.
  • Patients are unable to communicate with the investigator.
  • Patients have a history of allergic reactions to clozapine or chemically related psychotropic drugs.
  • Patients have a concurrent primary psychiatric or neurological diagnosis, including organic mental disorder (DSM-IV criteria), mental retardation, severe tardive dyskinesia, or idiopathic Parkinson's disease.
  • Patients have had electroconvulsive therapy within the past three months.
  • Patients have demonstrated clinically significant homicidal behavior within the past 12 months.
  • Patients have received an investigational drug within the past 30 days.
  • Patients have a history of narrow-angle glaucoma.
  • Patients require treatment with drugs that are known to interact with clozapine (e.g., agents having a well-known potential to suppress bone-marrow functioning, drugs that are highly protein-bound, cimetidine, or phenytoin). Clozapine may also potentiate the effects of antihypertensives and anticholinergics; therefore, caution should be taken if patients receiving these drugs are enrolled in the study.
  • Patients are morbidly obese (defined as having a body mass index [BMI] greater than 40; BMI = weight [kg]/height [m2]).
  • Patients have a known history of phenylketonuria. FazaClo contains aspartame, a source of phenylalanine which can be harmful to patients with phenylketonuria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Fazaclo
open label switch from generic clozapine to Fazaclo
Drug: Fazaclo
single-arm
Other Names:
  • Fazaclo clozapine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the equivalence of generic clozapine tablets to FazaClo in patients with schizophrenia or schizoaffective disorder who are already taking generic clozapine and are switched to FazaClo.
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Whether side effects are comparable when equivalent plasma levels are present
Time Frame: 14 days
14 days
Whether clinical efficacy is maintained after the switch to Fazaclo
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Manhattan Psychiatric Center

Collaborators

Azur Pharma, Inc

Investigators

  • Study Chair: Saurabh Kaushik, MD, Nathan Kline Institute & Manhattan Psychiatric Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

July 12, 2007

First Submitted That Met QC Criteria

July 13, 2007

First Posted (Estimate)

July 16, 2007

Study Record Updates

Last Update Posted (Estimate)

April 15, 2015

Last Update Submitted That Met QC Criteria

April 14, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06I/C02-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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