SchizophreniaPhase 1NCT02091388
Bioavailability of LY03004 and Risperdal® Consta®
A Phase 1 study testing LY03004 and Risperdal® Consta® in people with Schizophrenia and Schizoaffective Disorder, run by Luye Pharma Group Ltd. at 10 sites in United States.
Trial summary
This study is to assess the bioavailability of LY03004 compared to Risperdal Consta as well as the evaluate the safety and tolerability and preliminary efficacy of LY03004 with repeat injections Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- LY03004 and Risperdal® Consta®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 10 sitesUnited States
- Study dates
- Sep 2014to Jan 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 18 to 65 years old
- Patients must have a DSM-IV-TR 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 authorized representative
Who cannot join
- Patients with a mental disorders other than schizophrenia or schizoaffective disorder, according to the DSM-IV-TR
- Patients who received oral risperidone or paliperidone or clozapine within 14 days prior to screening, or Risperdal® Consta® within 100 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" to the questions 4 or 5 for current or past 30 days on the screening form 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 to 7%
Show all 16Show fewer
- 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 within 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 stabilizers 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 use of contraception
- Patients who have any clinically relevant hepatic, renal and cardiac dysfunction, or other medical condition or laboratory abnormality, which in the judgment of the investigator would interfere with the subject's ability to participate in the study
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Atlanta Center for Medical Research
Atlanta, Georgia, 30308
Community Clinical Research Inc
Austin, Texas, 78754
Compass Research
Leesburg, Florida, 34748
Woodland International
Little Rock, Arkansas, 72211
Collaborative Neuroscience Network LLC
Long Beach, California, 90806
CRI LifeTree
Marlton, New Jersey, 08053
Neuropsychiatric Research Center of Orange County
Orange, California, 92868
CRI LifeTree
Philadelphia, Pennsylvania, 19139
CBH Health LLC
Rockville, Maryland, 20850
Comprehensive Clinical Development
Washington D.C., District of Columbia, 20016
About this study
Official title: A Randomized, Open-Label, Parallel-Group Study to Assess the Relative Bioavailability of LY03004 and Risperdal® Consta® at 25 mg Following Multiple Intramuscular Injections in Stable Patients With Schizophrenia or Schizoaffective Disorder
This study is to assess the bioavailability of LY03004 compared to Risperdal Consta as well as the evaluate the safety and tolerability and preliminary efficacy of LY03004 with repeat injections
Read the detailed description
- To assess the relative bioavailability of LY03004 compared to Risperdal® Consta® at 25 mg following multiple intramuscular injections at steady-state;
- To evaluate the safety and tolerability of LY03004 following repeated intramuscular injections
- To evaluate the preliminary efficacy of LY03004 following repeated intramuscular injections
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- LY03004, Risperdal® Consta®
- 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.
LY03004Drug
Risperdal® Consta®Drug
| Study group | Role | What they receive |
|---|---|---|
| LY03004 25 mg | Experimental | 5 intramuscular injections 25 mg over 113 days Receives: Drug: LY03004 |
| Risperdal® Consta® 25 mg | Active comparator | 5 intramuscular injections 25 mg over 113 days Receives: Drug: Risperdal® Consta® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax, Tmax, for Relative bioavailability of LY03004 compared to Risperdal® Consta®
Measured: 113 Days
Secondary outcomes (2)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 113 Days
The change of the PANSS score for the Preliminary efficacy of LY03004
Measured: 113 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Simon Li, Study chair, Luye Pharma Group Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091388
- Sponsor's protocol ID
- LY03004 MD
- Status last verified
- Mar 2015
- First submitted
- 18 Mar 2014
- Last updated
- 4 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 38244179
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Parallel-Group Study to Assess the Relative Bioavailability of LY03004 and Risperdal® Consta® at 25 mg Following Multiple Intramuscular Injections in Stable Patients With Schizophrenia or Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT02091388
- Acronym / sponsor ID
- LY03004 MD
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 19 Mar 2014 (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 study is to assess the bioavailability of LY03004 compared to Risperdal Consta as well as the evaluate the safety and tolerability and preliminary efficacy of LY03004 with repeat injections
Detailed description
- To assess the relative bioavailability of LY03004 compared to Risperdal® Consta® at 25 mg following multiple intramuscular injections at steady-state;
- To evaluate the safety and tolerability of LY03004 following repeated intramuscular injections
- To evaluate the preliminary efficacy of LY03004 following repeated intramuscular injections
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY03004 25 mg | Experimental | Drug: LY030045 intramuscular injections 25 mg over 113 days |
| Risperdal® Consta® 25 mg | Active comparator | Drug: Risperdal® Consta®5 intramuscular injections 25 mg over 113 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients aged 18 to 65 years old
- Patients must have a DSM-IV-TR 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 authorized representative
Key exclusion criteria (16 listed)
- Patients with a mental disorders other than schizophrenia or schizoaffective disorder, according to the DSM-IV-TR
- Patients who received oral risperidone or paliperidone or clozapine within 14 days prior to screening, or Risperdal® Consta® within 100 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" to the questions 4 or 5 for current or past 30 days on the screening form 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
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 |
|---|---|---|
| LY03004 | Drug | LY03004 25 mg |
| Risperdal® Consta® | Drug | Risperdal® Consta® 25 mg |
Primary outcome
Cmax, Tmax, for Relative bioavailability of LY03004 compared to Risperdal® Consta®
Time frame: 113 Days
2 secondary outcomes
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 113 Days
The change of the PANSS score for the Preliminary efficacy of LY03004
Time frame: 113 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 4 Mar 2015.
- Derived from this study: PubMed 38244179Wang 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.
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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.
Simon Li study chair
Luye Pharma Group Ltd.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY03004 and Risperdal® Consta® in people with Schizophrenia and Schizoaffective Disorder, run by Luye Pharma Group Ltd. at 10 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 5 inclusion and 16 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 4 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 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?
Cmax, Tmax, for Relative bioavailability of LY03004 compared to Risperdal® Consta® (time frame: 113 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02091388, which also lists 1 linked publication.
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 4 Mar 2015.