SchizophreniaPhase 2NCT01952132
Safety, Tolerability, and Pharmacokinetics of OMS643762 in Psychiatrically Stable Schizophrenia Subjects
A Phase 2 study testing OMS643762 in people with Schizophrenia, run by Omeros Corporation at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of OMS643762 (the study drug) in psychiatrically stable schizophrenia patients. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- OMS643762
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Apr 2014
- Phase
- Phase 2
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Competent to provide informed consent.
- Voluntarily provide informed consent and Health Insurance Portability and Accounting Act (HIPAA) Authorization in accordance with local regulations and governing Institutional Review Board (IRB) requirements prior to any procedures or evaluations performed specifically for the sole purpose of the study.
- Have a diagnosis of schizophrenia as defined in DSM-IV-TR.
- Are from 18 to 55 years of age inclusive at the screening visit.
- Have stable schizophrenia symptomatology for greater than or equal to three months at the screening visit, in the opinion of the investigator.
- For enrollment to Cohorts 1 and 2, have not taken any oral antipsychotic medication for at least seven days or any parenteral antipsychotic medication for at least 30 days prior to randomization. Subjects should have been on a stable medication regimen for greater than or equal to two months at the screening visit.
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- For enrollment to Cohorts 3, 4, and 5, have been on a stable medication regimen for greater than or equal to two months at the screening visit.
- Have normal clinical laboratory test results and ECG, or results with minor deviations, which are not considered to be clinically significant by the investigator.
- If able to reproduce, agree to use an acceptable method of birth control (e.g., condom and spermicide, oral birth control which has been stable for 30 days) or agree to remain abstinent from Visit 2 until 90 days after the last dose of study drug for males and 30 days after the last dose of study drug for females.
Who cannot join
- Have a history of lactose intolerance or allergy to dairy products.
- Are pregnant or lactating.
- Have a history or presence of significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or neurological disorders which, in the opinion of the investigator, increases the risk of the study drug or may confound the interpretation of study measures.
- Have a history of alcohol dependence (within 12 months of screening) or abuse (within six months of screening) as defined by DSM-IV-TR or consume excessive amounts of alcohol, in the opinion of the investigator.
- Have a history of substance dependence (within 12 months of screening) or abuse (within six months of screening) as defined by DSM-IV-TR (with the exception of nicotine and caffeine). Positive results on drug screening will be exclusionary unless the patient has a valid prescription for the medication (i.e., benzodiazepines).
- Have unstable depression, in the opinion of the investigator.
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- Have experienced EPS within 30 days prior to Visit 1.
- Are currently taking clozapine.
- Are currently taking aripiprazole (for enrollment to Cohorts 1 and 2).
- Have a history of blood donation in excess of 500 mL of blood within 30 days prior to Visit 1.
- Have received treatment with an investigational drug or device within 60 days prior to Visit 1.
- Have a positive test for human immunodeficiency virus (HIV) antibodies, Hepatitis B surface antigen or Hepatitis C antibody.
- Are an employee of Omeros, an investigator, a study staff member, or their immediate family member.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Randomized, Double-blind, Placebo-controlled, Sequential Dose Escalation Cohort Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of OMS643762 in Psychiatrically Stable Schizophrenia Subjects
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of OMS643762 (the study drug) in psychiatrically stable schizophrenia patients.
- Conditions
- Schizophrenia
- Being tested
- OMS643762, Placebo
- Keywords
- Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMS643762Drug
Also called OMS824
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| OMS643762 Low Dose | Experimental | Orally administering OMS643762 low dose daily for 14 days Receives: Drug: OMS643762 |
| OMS643762 High Dose | Experimental | Orally administering OMS643762 high dose daily for 14 days Receives: Drug: OMS643762 |
| Placebo | Placebo comparator | Orally administering placebo daily for 14 days Receives: Drug: Placebo |
| OMS643762 Medium Dose | Experimental | Orally administering OMS643762 medium dose daily for 14 days Receives: Drug: OMS643762 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Incidence of adverse events
Measured: 14 days
Secondary outcomes (5)
Pharmacokinetics
Maximum plasma concentration of OMS643762 following multiple-dose administration
Measured: Pre-dose and up to 10 days post-dose
Pharmacokinetics
Area under the concentration-time curve of OMS643762 following multiple-dose administration
Measured: Pre-dose and up to 10 days post-dose
Cognition
Time to complete the Trail Making Test
Measured: Pre-dose and on day 14 of dosing
Cognition
Number of correct responses on the Stroop Color and Word Test
Measured: Pre-dose and on day 14 of dosing
Cognition
Number of correct responses on the Hopkin's Verbal Learning Test-Revised
Measured: Pre-dose and on day 14 of dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionApr 2014
- Study completionApr 2014
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omeros Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Albert Yu, MD, Study director, Omeros Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952132
- Sponsor's protocol ID
- OMS824-SCZ-001
- Status last verified
- Oct 2018
- First submitted
- 19 Sep 2013
- Last updated
- 22 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Randomized, Double-blind, Placebo-controlled, Sequential Dose Escalation Cohort Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of OMS643762 in Psychiatrically Stable Schizophrenia Subjects
- ClinicalTrials.gov ID
- NCT01952132
- Acronym / sponsor ID
- OMS824-SCZ-001
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Omeros CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 27 Sep 2013 (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 determine the safety, tolerability and pharmacokinetics of OMS643762 (the study drug) in psychiatrically stable schizophrenia patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| OMS643762 Low Dose | Experimental | Drug: OMS643762Orally administering OMS643762 low dose daily for 14 days |
| OMS643762 High Dose | Experimental | Drug: OMS643762Orally administering OMS643762 high dose daily for 14 days |
| Placebo | Placebo comparator | Drug: PlaceboOrally administering placebo daily for 14 days |
| OMS643762 Medium Dose | Experimental | Drug: OMS643762Orally administering OMS643762 medium dose daily for 14 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Competent to provide informed consent.
- Voluntarily provide informed consent and Health Insurance Portability and Accounting Act (HIPAA) Authorization in accordance with local regulations and governing Institutional Review Board (IRB) requirements prior to any procedures or evaluations performed specifically for the sole purpose of the study.
- Have a diagnosis of schizophrenia as defined in DSM-IV-TR.
- Are from 18 to 55 years of age inclusive at the screening visit.
- Have stable schizophrenia symptomatology for greater than or equal to three months at the screening visit, in the opinion of the investigator.
Key exclusion criteria (13 listed)
- Have a history of lactose intolerance or allergy to dairy products.
- Are pregnant or lactating.
- Have a history or presence of significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or neurological disorders which, in the opinion of the investigator, increases the risk of the study drug or may confound the interpretation of study measures.
- Have a history of alcohol dependence (within 12 months of screening) or abuse (within six months of screening) as defined by DSM-IV-TR or consume excessive amounts of alcohol, in the opinion of the investigator.
- Have a history of substance dependence (within 12 months of screening) or abuse (within six months of screening) as defined by DSM-IV-TR (with the exception of nicotine and caffeine). Positive results on drug screening will be exclusionary unless the patient has a valid prescription for the medication (i.e., benzodiazepines).
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 |
|---|---|---|
| OMS643762Also: OMS824 | Drug | OMS643762 High Dose, OMS643762 Low Dose, OMS643762 Medium Dose |
| Placebo | Drug | Placebo |
Primary outcome
Safety
Time frame: 14 days
Incidence of adverse events
5 secondary outcomes
Pharmacokinetics
Time frame: Pre-dose and up to 10 days post-dose
Pharmacokinetics
Time frame: Pre-dose and up to 10 days post-dose
Cognition
Time frame: Pre-dose and on day 14 of dosing
Cognition
Time frame: Pre-dose and on day 14 of dosing
Cognition
Time frame: Pre-dose and on day 14 of dosing
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 22 Oct 2018.
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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.
Albert Yu, MD study director
Omeros Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OMS643762 in people with Schizophrenia, run by Omeros Corporation 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 13 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 22 Oct 2018. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety (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 22 Oct 2018.