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

NCT00501618 | Completed Phase 4 DMC

• 1 other identifier: 06I/C02-1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

Schizophrenia; Schizoaffective Disorder; Orally dissolving clozapine; orally disintegrating clozapine; bio-equivalence; desmethylclozapine; clozapine plasma level; equivalence; fazaclo; generic clozapine

Outcome Measures

Primary Outcomes (1)

• 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.

  14 days

Secondary Outcomes (2)

• Whether side effects are comparable when equivalent plasma levels are present

  14 days

• Whether clinical efficacy is maintained after the switch to Fazaclo

  14 days

Study Arms (1)

Fazaclo

OTHER

open label switch from generic clozapine to Fazaclo

Drug: Fazaclo

Interventions

Fazaclo DRUG

single-arm

Also known as: Fazaclo clozapine

Fazaclo

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Manhattan Psychiatric Center: lead
• Azur Pharma, Inc: collaborator

Study Sites (2)

Manhattan Psychiatric Center, 125th Street, Out Patient Clinic

New York, New York, 10027, United States

Location

Manhattan Psychiatric Center, Inpatient Unit

New York, New York, 10035, United States

Location

Related Links

• Clozapine on Wikipedia
• Clozapine Registery

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Clozapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jean-Pierre Lindenmayer, MD

  Manhattan Psychiatric Center

  PRINCIPAL INVESTIGATOR

• Saurabh Kaushik, MD

  Nathan Kline Institute & Manhattan Psychiatric Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director

Study Record Dates

• First Submitted: July 12, 2007
• First Posted: July 16, 2007
• Study Start: November 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: July 1, 2009
• Last Updated: April 15, 2015

Record last verified: 2015-04

Locations

US (2)