SchizophreniaPhase 1NCT04510298
A Study of the Safety, PK, and Exploratory Efficacy of SP-624 in Acutely Psychotic Adult Subjects With Schizophrenia
A Phase 1 study testing SP-624 in people with Schizophrenia, run by Sirtsei Pharmaceuticals, Inc. at 2 sites in United States.
Trial summary
This is a Phase 1B clinical study evaluating the safety and exploring the effectiveness of SP-624 as compared to placebo in the treatment of adults with schizophrenia experiencing acute psychosis. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- SP-624
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Oct 2020to 15 Apr 2021
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Is willing and able to provide written informed consent to participate in the study.
- Has an identified reliable informant.
- Is, in the investigator's opinion, suitable for initiating a washout from the subject's current antipsychotic regimen, if applicable, and is willing to abstain from prohibited psychotropic medications in accordance with study requirements.
- Subjects must meet screening eligibility criteria and be in an inpatient setting prior to discontinuing antipsychotic medications.
- Subject must be able, in the investigator's opinion, to safely discontinue prohibited psychotropic medications prior to Baseline without increased suicidality.
- Has a primary diagnosis of schizophrenia based on the Diagnostic and Statistical Manual 5th edition (DSM-5) criteria and confirmed by Mini International Neuropsychiatric Interview (MINI) for Psychotic Disorders Studies.
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- Is experiencing an acute exacerbation or relapse of symptoms.
- Is in generally good physical health, in the investigator's opinion, based on Screening medical history, physical examination, vital signs, and clinical laboratory values.
- Has a body mass index (BMI) between 18 and 40 kg/m2, inclusive.
- For women of reproductive potential: has a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline.
- For women of reproductive potential and men with female partners of reproductive potential: agrees to remain abstinent from sexual intercourse or use adequate and reliable contraception throughout the study and for at least 30 days after the last dose of study drug.
Who cannot join
- Is a woman who is pregnant, breastfeeding, or less than 6 months postpartum at Screening.
- Has any primary DSM-5 disorder other than schizophrenia, as confirmed by the MINI.
- Fails to discontinue prohibited psychotropic medications.
- Has, in the investigator's opinion, a significant risk of violent or destructive behavior.
- Is currently hospitalized involuntarily or incarcerated.
- Has a history or presence of any clinically significant medical condition, disease, or surgical history that could, in the investigator's opinion, jeopardize the safety of the subject or validity of the study data, or interfere with the absorption, distribution, metabolism, or excretion of the study drug.
- Is, in the investigator's opinion, not a suitable candidate for the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Collaborative Neuroscience Research
Garden Grove, California, 92845
Hassman Research Institute
Marlton, New Jersey, 08053
About this study
Official title: A Pilot, 4-Week, Randomized, Double-Blind, Placebo-Controlled, Inpatient, Multicenter Study of the Safety, Population Pharmacokinetics, and Exploratory Efficacy of SP-624 in Acutely Psychotic Adult Subjects With Schizophrenia
This is a Phase 1B clinical study evaluating the safety and exploring the effectiveness of SP-624 as compared to placebo in the treatment of adults with schizophrenia experiencing acute psychosis.
- Conditions
- Schizophrenia
- Being tested
- SP-624, Placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SP-624Drug
Oral Capsule
PlaceboDrug
Oral Capsule
| Study group | Role | What they receive |
|---|---|---|
| SP-624 | Experimental | SP-624 oral capsule, 20 mg once daily Receives: Drug: SP-624 |
| Placebo | Placebo comparator | Placebo oral capsule, once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
Measured: Up to 8 weeks
Secondary outcomes (12)
Number of Participants with Abnormal Clinical Laboratory Values
chemistry, hematology, and urinalysis tests will be performed
Measured: Up to 4 weeks
Change from Baseline in Blood Pressure (mmHg)
Blood pressure is measured by sphygmomanometer. Change from baseline measurement will be calculated
Measured: Up to 4 weeks
Change from Baseline in Pulse Rate (beats per minute)
Pulse rate is measured by sphygmomanometer. Change from baseline measurement will be calculated
Measured: Up to 4 weeks
Change from Baseline in Body Temperature (degrees celsius)
Body temperature is measured by oral thermometer. Change from baseline measurement will be calculated
Measured: Up to 4 weeks
Change from Baseline in Body Weight (kilograms)
Body weight is measured by weight scale. Measurement is reported in kilograms. Change from Baseline measurement will be calculated.
Measured: Up to 4 weeks
Change from Baseline in ECG Heart Rate (beats per minute)
Heart rate is measured by 12-lead electrocardiogram (ECG). Change from Baseline measure will be calculated.
Measured: Up to 4 weeks
Change from Baseline in ECG RR Interval (seconds)
RR interval is measured by 12-lead electrocardiogram (ECG). Change from Baseline measurement will be calculated.
Measured: Up to 4 weeks
Change from Baseline in ECG PR Interval (milliseconds)
PR interval is measured by 12-lead electrocardiogram (ECG). Change from Baseline measurement will be calculated.
Measured: Up to 4 weeks
Change from Baseline in ECG QTcF Interval (milliseconds)
QTcF is measured by 12-lead electrocardiogram (ECG). Change from Baseline measurement will be calculated.
Measured: Up to 4 weeks
Number of Participants with Abnormal Physical Examination Findings
Measured: Up to 4 weeks
Number of Participants with treatment-emergent suicidal ideation or behavior
Treatment-emergent suicidal ideation and/or behavior will be assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS) assessments
Measured: Up to 5 weeks
Number of Participants with treatment-emergent abnormal movements
Treatment-emergent abnormal movements will be assessed using a battery of movement assessments
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start15 Oct 2020
- Primary completion15 Apr 2021
- Study completion15 Apr 2021
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sirtsei Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510298
- Sponsor's protocol ID
- SP-624-221
- Status last verified
- Apr 2022
- First submitted
- 27 Jul 2020
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, 4-Week, Randomized, Double-Blind, Placebo-Controlled, Inpatient, Multicenter Study of the Safety, Population Pharmacokinetics, and Exploratory Efficacy of SP-624 in Acutely Psychotic Adult Subjects With Schizophrenia
- ClinicalTrials.gov ID
- NCT04510298
- Acronym / sponsor ID
- SP-624-221
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Sirtsei Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 12 Aug 2020 (actual)
- 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 a Phase 1B clinical study evaluating the safety and exploring the effectiveness of SP-624 as compared to placebo in the treatment of adults with schizophrenia experiencing acute psychosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SP-624 | Experimental | Drug: SP-624SP-624 oral capsule, 20 mg once daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo oral capsule, once daily |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Is willing and able to provide written informed consent to participate in the study.
- Has an identified reliable informant.
- Is, in the investigator's opinion, suitable for initiating a washout from the subject's current antipsychotic regimen, if applicable, and is willing to abstain from prohibited psychotropic medications in accordance with study requirements.
- Has a primary diagnosis of schizophrenia based on the Diagnostic and Statistical Manual 5th edition (DSM-5) criteria and confirmed by Mini International Neuropsychiatric Interview (MINI) for Psychotic Disorders Studies.
- Is experiencing an acute exacerbation or relapse of symptoms.
Key exclusion criteria (7 listed)
- Is a woman who is pregnant, breastfeeding, or less than 6 months postpartum at Screening.
- Has any primary DSM-5 disorder other than schizophrenia, as confirmed by the MINI.
- Fails to discontinue prohibited psychotropic medications.
- Has, in the investigator's opinion, a significant risk of violent or destructive behavior.
- Is currently hospitalized involuntarily or incarcerated.
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 |
|---|---|---|
| SP-624Oral Capsule | Drug | SP-624 |
| PlaceboOral Capsule | Drug | Placebo |
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: Up to 8 weeks
12 secondary outcomes
Number of Participants with Abnormal Clinical Laboratory Values
Time frame: Up to 4 weeks
Change from Baseline in Blood Pressure (mmHg)
Time frame: Up to 4 weeks
Change from Baseline in Pulse Rate (beats per minute)
Time frame: Up to 4 weeks
Change from Baseline in Body Temperature (degrees celsius)
Time frame: Up to 4 weeks
Change from Baseline in Body Weight (kilograms)
Time frame: Up to 4 weeks
Change from Baseline in ECG Heart Rate (beats per minute)
Time frame: Up to 4 weeks
Change from Baseline in ECG RR Interval (seconds)
Time frame: Up to 4 weeks
Change from Baseline in ECG PR Interval (milliseconds)
Time frame: Up to 4 weeks
Change from Baseline in ECG QTcF Interval (milliseconds)
Time frame: Up to 4 weeks
Number of Participants with Abnormal Physical Examination Findings
Time frame: Up to 4 weeks
Number of Participants with treatment-emergent suicidal ideation or behavior
Time frame: Up to 5 weeks
Number of Participants with treatment-emergent abnormal movements
Time frame: Up to 4 weeks
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 25 Apr 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 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 SP-624 in people with Schizophrenia, run by Sirtsei Pharmaceuticals, Inc. 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 11 inclusion and 7 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 25 Apr 2022. 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. 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 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?
Incidence of Adverse Events (AEs) (time frame: Up to 8 weeks). 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 25 Apr 2022.