SchizophreniaPhase 1NCT02978599
Clinical Trial of AVL-3288 in Schizophrenia Patients
A Phase 1 study testing AVL-3288 in people with Schizophrenia and Schizoaffective Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
Single-center, outpatient, randomized, double-blind, placebo-controlled, 3-treatment-phase, cross-over study to evaluate the safety, tolerability and efficacy of two oral doses of AVL-3288 each compared to placebo, in patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- AVL-3288
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 2 Nov 2018
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DSM-V diagnosis of schizophrenia or schizoaffective disorder
- RBANS Total Scale Score >62
- Willing to provide informed consent
- Medically stable for study participation
- Taking an antipsychotic medication other than clozapine at a stable dose for at least 4 weeks
- Judged clinically not to be at significant suicide or violence risk
Who cannot join
- Substance abuse (excluding nicotine) within last 90 days
- ECG abnormality that is clinically significant
- Current clozapine use
- Participation in a study of investigational medication/device within 4 weeks
- Pregnancy, lactation, or lack of use of effective birth control
- Active tobacco use
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- Presence or positive history of significant medical or neurological illness, including cardiac illness, WBC <3500/mm3, absolute neutrophil count <1500/mm3, ALT or AST values >1.5 times upper limit of normal. Hemoglobin less than 130 g/L (13 g/dL) in males or 120 g/L (12 g/dL) in females or known HIV +
- Contraindication to MRI scanning, including metal implants or claustrophobia
- Medicinal patch, unless removed
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Double Blind, Two Dose, Cross-over Clinical Trial of the Positive Allosteric Modulator at the alpha7 Nicotinic Cholinergic Receptor AVL-3288 in Schizophrenia Patients
Single-center, outpatient, randomized, double-blind, placebo-controlled, 3-treatment-phase, cross-over study to evaluate the safety, tolerability and efficacy of two oral doses of AVL-3288 each compared to placebo, in patients with schizophrenia.
Read the detailed description
This study will be in 24 non-smoking outpatients with schizophrenia or schizoaffective disorder. Subjects will complete three treatment phases, each involving 5 straight days of taking AVL-3288 (10 mg or 30 mg study drug or placebo) followed by a 16 day washout period in which subjects do not take the study drug to ensure that the drug is completed eliminated from the body before the next phase.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- AVL-3288, Placebo
- 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.
AVL-3288Drug
Also called Anvylic-3288
daily for 5 days
PlaceboDrug
daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| AVL-3288 10 mg | Experimental | AVL-3288 10 mg daily for 5 days Receives: Drug: AVL-3288 |
| AVL-3288 30 mg | Experimental | AVL-3288 30 mg daily for 5 days Receives: Drug: AVL-3288 |
| Placebo | Placebo comparator | Placebo daily for 5 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Score
Compare effect of active drug (AVL-3288) to placebo on RBANS total score
Measured: End of each 5-day treatment phase
Secondary outcomes (6)
RBANS index T-score subscales
Compare effect of active drug (AVL-3288) to placebo on RBANS index T-score subscales
Measured: End of each 5-day treatment phase
Brief Psychiatric Rating Scale (BPRS) Total score
Compare effect of active drug (AVL-3288) to placebo on BPRS Total Score.
Measured: End of each 5-day treatment phase
Calgary Depression Rating Scale (CDRS) Total score
Compare effect of active drug (AVL-3288) to placebo on CDRS Total Score.
Measured: End of each 5-day treatment phase
Scale for the Assessment of Negative Symptoms (SANS) Total score
Compare effect of active drug (AVL-3288) to placebo on SANS Total score
Measured: End of each 5-day treatment phase
P50 suppression measured by electroencephalographic (EEG)
Compare P50 suppression measured by EEG between active drug (AVL-3288) and placebo
Measured: End of each 5-day treatment phase
Intensity of hippocampal BOLD fMRI signal during MRI scan
Compare intensity of Hippocampal BOLD signal between active drug (AVL-3288) and placebo
Measured: end of each 5-day treatment phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study startNov 2016
- Primary completion26 Oct 2018
- Study completion2 Nov 2018
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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Joshua Kantrowitz, New York State Psychiatric Institute
- Investigators
- Jeffrey A Lieberman, MD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978599
- Sponsor's protocol ID
- 7370
- Other IDs
- U01MH094247-01
- Status last verified
- Jan 2019
- First submitted
- 17 Nov 2016
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Two Dose, Cross-over Clinical Trial of the Positive Allosteric Modulator at the alpha7 Nicotinic Cholinergic Receptor AVL-3288 in Schizophrenia Patients
- ClinicalTrials.gov ID
- NCT02978599
- Acronym / sponsor ID
- 7370
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2016
- Primary completion
- 26 Oct 2018 (actual)
- Study completion
- 2 Nov 2018 (actual)
- First posted
- 1 Dec 2016 (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.
Single-center, outpatient, randomized, double-blind, placebo-controlled, 3-treatment-phase, cross-over study to evaluate the safety, tolerability and efficacy of two oral doses of AVL-3288 each compared to placebo, in patients with schizophrenia.
Detailed description
This study will be in 24 non-smoking outpatients with schizophrenia or schizoaffective disorder. Subjects will complete three treatment phases, each involving 5 straight days of taking AVL-3288 (10 mg or 30 mg study drug or placebo) followed by a 16 day washout period in which subjects do not take the study drug to ensure that the drug is completed eliminated from the body before the next phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AVL-3288 10 mg | Experimental | Drug: AVL-3288AVL-3288 10 mg daily for 5 days |
| AVL-3288 30 mg | Experimental | Drug: AVL-3288AVL-3288 30 mg daily for 5 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo daily for 5 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- DSM-V diagnosis of schizophrenia or schizoaffective disorder
- RBANS Total Scale Score >62
- Willing to provide informed consent
- Medically stable for study participation
- Taking an antipsychotic medication other than clozapine at a stable dose for at least 4 weeks
Key exclusion criteria (9 listed)
- Substance abuse (excluding nicotine) within last 90 days
- ECG abnormality that is clinically significant
- Current clozapine use
- Participation in a study of investigational medication/device within 4 weeks
- Pregnancy, lactation, or lack of use of effective birth control
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 |
|---|---|---|
| AVL-3288Also: Anvylic-3288daily for 5 days | Drug | AVL-3288 10 mg, AVL-3288 30 mg |
| Placebodaily for 5 days | Drug | Placebo |
Primary outcome
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Score
Time frame: End of each 5-day treatment phase
Compare effect of active drug (AVL-3288) to placebo on RBANS total score
6 secondary outcomes
RBANS index T-score subscales
Time frame: End of each 5-day treatment phase
Brief Psychiatric Rating Scale (BPRS) Total score
Time frame: End of each 5-day treatment phase
Calgary Depression Rating Scale (CDRS) Total score
Time frame: End of each 5-day treatment phase
Scale for the Assessment of Negative Symptoms (SANS) Total score
Time frame: End of each 5-day treatment phase
P50 suppression measured by electroencephalographic (EEG)
Time frame: End of each 5-day treatment phase
Intensity of hippocampal BOLD fMRI signal during MRI scan
Time frame: end of each 5-day treatment phase
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 Jan 2019.
- Individual participant dataSharing planned: Yes
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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.
Jeffrey A Lieberman, MD principal investigator
New York State Psychiatric Institute
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 AVL-3288 in people with Schizophrenia and Schizoaffective Disorder, run by New York State Psychiatric Institute 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 6 inclusion and 9 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 Jan 2019. 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 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?
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Score (time frame: End of each 5-day treatment phase). 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 Jan 2019.