SchizophreniaPhase 1NCT02411526
Safety and PK Trial With Injectable ZX003 (Risperidone-SABER®) Compared to Risperdal® Consta® in Stable Schizophrenia
A Phase 1 study testing ZX003 (Risperidone-SABER®), Risperdal Consta and Oral Risperidone in people with Schizophrenia and Schizoaffective Disorder, run by Zogenix, Inc. at 1 site in United States.
Trial summary
This is an open-label, multiple dose, PK and safety study in patients with chronic, stable schizophrenia or schizoaffective disorder. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- ZX003 (Risperidone-SABER®), Risperdal Consta and Oral Risperidone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Sep 2015
- Phase
- Phase 1
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female patients 18 - 60 years of age, inclusive.
- Diagnosis of schizophrenia, or schizoaffective disorder as per DSM-V criteria in the past 6 months or more, dependent on diagnosis.
- Currently on maintenance antipsychotic medication (ie, patients treated with antipsychotic medication with stable doses in the 4 weeks prior to Screening and no psychosis-related dose changes in the 8 weeks prior to Screening).
- Body Mass Index (BMI) ≥20 and ≤40 kg/m2.
- Female patients who are non-childbearing potential (surgically sterile [hysterectomy]) or post-menopausal ≥2 years; or non-pregnant, non-lactating females of childbearing potential who agree to use medically acceptable forms of birth control (hormonal contraception, abstinence, diaphragm with spermicide, condom with spermicide, or intrauterine device) from Screening until the End-of-Study visit.
- No clinically significant abnormal laboratory values.
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- No clinically significant findings in the 12-lead ECG.
- No clinically significant findings from a vital signs measurement.
- Be informed of the nature of the study and give written consent prior to initiating any study procedure.
Who cannot join
- Unwilling to provide genotyping (phenotyping) sample for CYP2D6.
- Have known or suspected carcinoma.
- Have known presence or history of renal or hepatic insufficiency.
- Have known history, hypersensitivity or clinically significant idiosyncratic reaction to risperidone, paliperidone, and/or any other drug substance with similar activity.
- Have a history of alcohol or drug-dependence as per DSM-V criteria during the 6-month period immediately prior to Screening.
- Have a history of epilepsy or risk of having seizures.
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- Are pregnant, lactating, or likely to become pregnant during the study.
- Have taken an antipsychotic depot product (including investigational products) within the 60 days prior to Screening.
- Participated in another clinical trial or received an investigational product within 30 days prior to Screening.
- Have a positive alcohol breathalyzer test at Screening or Admission.
- Have a positive Screening test for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- Have a positive urine drug test (cocaine, amphetamines, barbiturates, opiates, benzodiazepines (unless prescribed), cannabinoids, etc.) at Screening or Admission.
- Excessive use of caffeine-containing beverages exceeding 500 mg caffeine/day (5 cups of coffee).
- Use of alcohol or alcohol-containing foods, medications or beverages, within 48 hours prior to Admission.
- Excessive smoking, defined as smoking more than 2 packs of cigarettes (or 5 cigars) per day for 1 year or greater.
- Donation of blood (>500 mL) or blood products within 2 months (56 days) prior to Admission.
- Have used any concomitant medications significantly impacting CYP2D6 (moderate and strong inducers/inhibitors),within 14 days or 5 half-lives (whichever is longer) prior to Admission. Medications judged to not interact with risperidone may be continued at the discretion of the Investigator and in accordance with the protocol requirements for tapering and washout.
- Are unable to understand the protocol requirements, instructions and study related restrictions, the nature, scope and possible consequences of the clinical study.
- Are unlikely to comply with the protocol requirements, instructions and study- related restrictions (eg, uncooperative attitude, inability to return for out-patient visits or improbability of completing the clinical study).
- Are unable to tolerate the Oral Risperidone Challenge
Trial locations and contacts
1 site in 1 country.
United States1 site
Collaborative Neuroscience Network
Long Beach, California, 90806
About this study
Official title: An Open-Label, Multiple Dose, Safety and Pharmacokinetic Trial With Injectable ZX003 (Risperidone-SABER®) Compared to Risperdal® Consta® in Patients With Chronic, Stable Schizophrenia or Schizoaffective Disorder
This is an open-label, multiple dose, PK and safety study in patients with chronic, stable schizophrenia or schizoaffective disorder.
Read the detailed description
Approximately 75 male and female patients with schizophrenia or schizoaffective disorder on antipsychotic maintenance medication will be enrolled into the study. There will be 4 planned cohorts of 14 patients per cohort.
In Cohorts 1-3, patients' planned participation in the study is for a total of approximately 22 weeks, including a Screening period of up to 35 days, and a study treatment period of 120 days (including follow-up).
In Cohort 4 planned participation in the study is for a total of approximately 18 weeks including a Screening period of up to 35 days and a study treatment of 92 days (including follow-up).
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- ZX003 (Risperidone-SABER®), Risperdal Consta, Oral Risperidone
- 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.
ZX003 (Risperidone-SABER®)Drug
Also called Relday
ZX003 administered as a SC injection
Risperdal ConstaDrug
Also called risperidone
Risperdal Consta administered as a IM injection
Oral RisperidoneDrug
Also called risperdal
Oral Risperidone given to ensure adequate therapeutic plasma concentrations from Risperdal Consta
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 60 mg of ZX003 administered 4 times (every 4 weeks) Receives: Drug: ZX003 (Risperidone-SABER®) |
| Cohort 2 | Experimental | 90 mg of ZX003 administered 4 times (every 4 weeks) Receives: Drug: ZX003 (Risperidone-SABER®) |
| Cohort 3 | Experimental | 120 mg of ZX003 administered 4 times (every 4 weeks) Receives: Drug: ZX003 (Risperidone-SABER®) |
| Cohort 4 | Active comparator | Risperdal Consta administered 5 times (once every 2 weeks) NOTE: Oral risperidone 2 mg will be given with the first injection of Risperdal Consta and continued for 3 weeks (and then discontinued) to ensure adequate therapeutic plasma concentrations from Risperdal Consta. Receives: Drug: Risperdal Consta; Drug: Oral Risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK profile of ZX003 determined by C max, T max, C min, AUC (0-24h), AUC (0-tau), C avg
Measured: Day 1 through day 120
Secondary outcomes (2)
Safety and tolerability of ZX003 as measured by assessing adverse events.
Measured: Day 1 through day 120
Safety and tolerability of ZX003 as measured by assessing laboratory values.
Measured: Day 1 through day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionSep 2015
- Study completionSep 2015
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zogenix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Walling, PhD, Principal investigator, Collaborative Neuroscience Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411526
- Sponsor's protocol ID
- ZX003-1401
- Status last verified
- Jul 2015
- First submitted
- 16 Mar 2015
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multiple Dose, Safety and Pharmacokinetic Trial With Injectable ZX003 (Risperidone-SABER®) Compared to Risperdal® Consta® in Patients With Chronic, Stable Schizophrenia or Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT02411526
- Acronym / sponsor ID
- ZX003-1401
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zogenix, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 8 Apr 2015 (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.
This is an open-label, multiple dose, PK and safety study in patients with chronic, stable schizophrenia or schizoaffective disorder.
Detailed description
Approximately 75 male and female patients with schizophrenia or schizoaffective disorder on antipsychotic maintenance medication will be enrolled into the study. There will be 4 planned cohorts of 14 patients per cohort.
In Cohorts 1-3, patients' planned participation in the study is for a total of approximately 22 weeks, including a Screening period of up to 35 days, and a study treatment period of 120 days (including follow-up).
In Cohort 4 planned participation in the study is for a total of approximately 18 weeks including a Screening period of up to 35 days and a study treatment of 92 days (including follow-up).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: ZX003 (Risperidone-SABER®)60 mg of ZX003 administered 4 times (every 4 weeks) |
| Cohort 2 | Experimental | Drug: ZX003 (Risperidone-SABER®)90 mg of ZX003 administered 4 times (every 4 weeks) |
| Cohort 3 | Experimental | Drug: ZX003 (Risperidone-SABER®)120 mg of ZX003 administered 4 times (every 4 weeks) |
| Cohort 4 | Active comparator | Drug: Risperdal Consta, Drug: Oral RisperidoneRisperdal Consta administered 5 times (once every 2 weeks) NOTE: Oral risperidone 2 mg will be given with the first injection of Risperdal Consta and continued for 3 weeks (and then discontinued) to ensure adequate therapeutic plasma concentrations from Risperdal Consta. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male or female patients 18 - 60 years of age, inclusive.
- Diagnosis of schizophrenia, or schizoaffective disorder as per DSM-V criteria in the past 6 months or more, dependent on diagnosis.
- Currently on maintenance antipsychotic medication (ie, patients treated with antipsychotic medication with stable doses in the 4 weeks prior to Screening and no psychosis-related dose changes in the 8 weeks prior to Screening).
- Body Mass Index (BMI) ≥20 and ≤40 kg/m2.
- Female patients who are non-childbearing potential (surgically sterile [hysterectomy]) or post-menopausal ≥2 years; or non-pregnant, non-lactating females of childbearing potential who agree to use medically acceptable forms of birth control (hormonal contraception, abstinence, diaphragm with spermicide, condom with spermicide, or intrauterine device) from Screening until the End-of-Study visit.
Key exclusion criteria (20 listed)
- Unwilling to provide genotyping (phenotyping) sample for CYP2D6.
- Have known or suspected carcinoma.
- Have known presence or history of renal or hepatic insufficiency.
- Have known history, hypersensitivity or clinically significant idiosyncratic reaction to risperidone, paliperidone, and/or any other drug substance with similar activity.
- Have a history of alcohol or drug-dependence as per DSM-V criteria during the 6-month period immediately prior to Screening.
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 |
|---|---|---|
| ZX003 (Risperidone-SABER®)Also: ReldayZX003 administered as a SC injection | Drug | Cohort 1, Cohort 2, Cohort 3 |
| Risperdal ConstaAlso: risperidoneRisperdal Consta administered as a IM injection | Drug | Cohort 4 |
| Oral RisperidoneAlso: risperdalOral Risperidone given to ensure adequate therapeutic plasma concentrations from Risperdal Consta | Drug | Cohort 4 |
Primary outcome
PK profile of ZX003 determined by C max, T max, C min, AUC (0-24h), AUC (0-tau), C avg
Time frame: Day 1 through day 120
2 secondary outcomes
Safety and tolerability of ZX003 as measured by assessing adverse events.
Time frame: Day 1 through day 120
Safety and tolerability of ZX003 as measured by assessing laboratory values.
Time frame: Day 1 through day 120
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 31 Oct 2022.
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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.
David Walling, PhD principal investigator
Collaborative Neuroscience Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZX003 (Risperidone-SABER®), Risperdal Consta and Oral Risperidone in people with Schizophrenia and Schizoaffective Disorder, run by Zogenix, Inc. at 1 site 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 9 inclusion and 20 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 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
PK profile of ZX003 determined by C max, T max, C min, AUC (0-24h), AUC (0-tau), C avg (time frame: Day 1 through day 120). 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 31 Oct 2022.