SchizophreniaPhase 4NCT00501618
Equivalence of Generic Clozapine to Orally Dissolving Clozapine in Schizophrenia or Schizoaffective Disorder
A Phase 4 study testing Fazaclo in people with Schizophrenia and Schizoaffective Disorder, run by Manhattan Psychiatric Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Fazaclo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2006to Jul 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Manhattan Psychiatric Center, 125th Street, Out Patient Clinic
New York, New York, 10027
Manhattan Psychiatric Center, Inpatient Unit
New York, New York, 10035
About this study
Official title: 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.
Read the 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.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Fazaclo
- Keywords
- Schizophrenia, Schizoaffective Disorder, Orally dissolving clozapine, orally disintegrating clozapine, bio-equivalence, desmethylclozapine, clozapine plasma level, equivalence, fazaclo, generic clozapine
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FazacloDrug
Also called Fazaclo clozapine
single-arm
| Study group | Role | What they receive |
|---|---|---|
| Fazaclo | Other | open label switch from generic clozapine to Fazaclo Receives: Drug: Fazaclo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Secondary outcomes (2)
Whether side effects are comparable when equivalent plasma levels are present
Measured: 14 days
Whether clinical efficacy is maintained after the switch to Fazaclo
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2007 (estimated)
- Study startNov 2006
- Primary completionMar 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manhattan Psychiatric Center
- Sponsor type
- University, hospital or other
- Collaborators
- Azur Pharma, Inc
- Responsible party
- Principal investigator, Jean-Pierre Lindenmayer, Manhattan Psychiatric Center
- Investigators
- Jean-Pierre Lindenmayer, MD, Principal investigator, Manhattan Psychiatric CenterSaurabh Kaushik, MD, Study chair, Nathan Kline Institute & Manhattan Psychiatric Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501618
- Sponsor's protocol ID
- 06I/C02-1
- Status last verified
- Apr 2015
- First submitted
- 12 Jul 2007
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study Changing Generic Clozapine Formulation to FazaClo® (Clozapine, USP) Orally Disintegrating Tablets in Stable Patients With Schizophrenia or Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT00501618
- Acronym / sponsor ID
- 06I/C02-1
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Schizophrenia, Schizoaffective Disorder, Orally dissolving clozapine, orally disintegrating clozapine, bio-equivalence, desmethylclozapine, clozapine plasma level, equivalence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Manhattan Psychiatric CenterUniversity, hospital or other
- Collaborators
- Azur Pharma, Inc
- Study start
- Nov 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 16 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fazaclo | Other | Drug: Fazacloopen label switch from generic clozapine to Fazaclo |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FazacloAlso: Fazaclo clozapinesingle-arm | Drug | Fazaclo |
Primary outcome
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
2 secondary outcomes
Whether side effects are comparable when equivalent plasma levels are present
Time frame: 14 days
Whether clinical efficacy is maintained after the switch to Fazaclo
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
- Clozapine on WikipediaLink provided by the sponsor.
- Clozapine RegisteryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Pierre Lindenmayer, MD principal investigator
Manhattan Psychiatric Center
Saurabh Kaushik, MD study chair
Nathan Kline Institute & Manhattan Psychiatric Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fazaclo in people with Schizophrenia and Schizoaffective Disorder, run by Manhattan Psychiatric Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2015.