Schizophrenia DisordersPhase 2NCT01163227
Effect of AQW051 on Cognitive Function in Patients With Chronic Stable Schizophrenia
A Phase 2 study testing AQW051 2 mg (single and multiple doses), AQW051 15mg (single and multiple doses) and AQW051 100mg (single dose), and 50mg (multiple doses) in people with Schizophrenia Disorders, run by Novartis Pharmaceuticals at 2 sites in United States.
Trial summary
This PoC study is designed to assess the cognitive effects of doses of AQW051 in patients with chronic stable schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia Disorders
- What is being tested?
- AQW051 2 mg (single and multiple doses), AQW051 15mg (single and multiple doses) and AQW051 100mg (single dose), and 50mg (multiple doses)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2010to Sep 2011
- 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
- Diagnosis of schizophrenia
- Symptomatically stable and currently treated with a stable regimen for at least 3 (three) months prior to dosing with one of the following second generation of antipsychotics: risperidone, paliperidone, quetiapine, ziprasidone, aripiprazole.
- Specific cognitive impairment
- Smokers and non-smokers
Who cannot join
- Current treatment with an anticholinergic or other agent known to adversely interfere with the cholinergic system, and/ or treatment with cholinesterase inhibitor within the last three (3) months prior to dosing.
- Current treatment with conventional antipsychotics (e.g fluphenazine, haloperidol) or clozapine.
- History of neuroleptic malignant syndrome.
- Diagnosis of substance abuse (other than nicotine) within the last month and alcohol or substance dependence (other than nicotine) within the last 6 months.
- Any clinically significant suicidal ideation (Type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the last month) or previous history of suicide behavior Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
2 sites in 1 country.
United States2 sites
PAREXEL (California Clinical Trials Medical Group), 1560 Chevy Chase Drive, Suite 140,
Glendale, California, 91206
CRI Worldwide, 1113 Hospital Dr. Suite 202,
Willingboro, New Jersey, 08046
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Cross-over, Single-dose Study to Evaluate the Effects of AQW051 on Cognitive Function in Patients With Chronic Stable Schizophrenia Including a One Week Multiple-dose Extension to Assess the Persistence of Observed Effects and a Multiple-dose Cross Over Study in Non Smokers Only.
This PoC study is designed to assess the cognitive effects of doses of AQW051 in patients with chronic stable schizophrenia.
- Conditions
- Schizophrenia Disorders
- Being tested
- Placebo (single and multiple doses), AQW051 2 mg (single and multiple doses), AQW051 15mg (single and multiple doses), AQW051 100mg (single dose), and 50mg (multiple doses)
- Keywords
- Hallucinations,, psychotic,, delusions,, cognitive deficits
- Medical subject headings
- Schizophrenia, Hallucinations, Mental Disorders, Delusions, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo (single and multiple doses)Drug
AQW051 2 mg (single and multiple doses)Drug
AQW051 15mg (single and multiple doses)Drug
AQW051 100mg (single dose), and 50mg (multiple doses)Drug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo (single and multiple doses) |
| AQW051 Dose 1 | Experimental | Not described Receives: Drug: AQW051 2 mg (single and multiple doses) |
| AQW051 Dose 2 | Experimental | Not described Receives: Drug: AQW051 15mg (single and multiple doses) |
| AQW051 Dose 3 | Experimental | Not described Receives: Drug: AQW051 100mg (single dose), and 50mg (multiple doses) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of single oral doses of AQW051 versus placebo on cognitive function as measured by selected CogState tests
Measured: 132 days Part A, 121 days Part B (screening to study completion)
Secondary outcomes (4)
Effects of single oral doses of AQW051 versus placebo on cognitive function as measured by selected MATRICS Consensus Cognitive Battery (MCCB) tests
Measured: 132 days Part A, 121 days Part B (screening to study completion)
Effects of multiple oral doses of AQW051 versus placebo on cognitive function as measured by selected CogState tests and selected MCCB tests
Measured: 132 days Part A, 121 days Part B (screening to study completion)
Correlation of the cognitive domains measured by MCCB versus CogState
Measured: 132 days Part A, 121 days Part B (screening to study completion)
Pharmacokinetics, safety and tolerability of single and multiple doses of AQW051 as compared to placebo
Measured: 132 days Part A, 121 days Part B (screening to study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2010 (estimated)
- Study startMay 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia DisordersStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01163227
- Sponsor's protocol ID
- CAQW051A2205
- Status last verified
- Mar 2013
- First submitted
- 12 Jul 2010
- Last updated
- 24 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Cross-over, Single-dose Study to Evaluate the Effects of AQW051 on Cognitive Function in Patients With Chronic Stable Schizophrenia Including a One Week Multiple-dose Extension to Assess the Persistence of Observed Effects and a Multiple-dose Cross Over Study in Non Smokers Only.
- ClinicalTrials.gov ID
- NCT01163227
- Acronym / sponsor ID
- CAQW051A2205
- Conditions
- Schizophrenia Disorders
- Keywords
- Hallucinations,, psychotic,, delusions,, cognitive deficits
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 15 Jul 2010 (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 PoC study is designed to assess the cognitive effects of doses of AQW051 in patients with chronic stable schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo (single and multiple doses) |
| AQW051 Dose 1 | Experimental | Drug: AQW051 2 mg (single and multiple doses) |
| AQW051 Dose 2 | Experimental | Drug: AQW051 15mg (single and multiple doses) |
| AQW051 Dose 3 | Experimental | Drug: AQW051 100mg (single dose), and 50mg (multiple doses) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosis of schizophrenia
- Symptomatically stable and currently treated with a stable regimen for at least 3 (three) months prior to dosing with one of the following second generation of antipsychotics: risperidone, paliperidone, quetiapine, ziprasidone, aripiprazole.
- Specific cognitive impairment
- Smokers and non-smokers
Key exclusion criteria (5 listed)
- Current treatment with an anticholinergic or other agent known to adversely interfere with the cholinergic system, and/ or treatment with cholinesterase inhibitor within the last three (3) months prior to dosing.
- Current treatment with conventional antipsychotics (e.g fluphenazine, haloperidol) or clozapine.
- History of neuroleptic malignant syndrome.
- Diagnosis of substance abuse (other than nicotine) within the last month and alcohol or substance dependence (other than nicotine) within the last 6 months.
- Any clinically significant suicidal ideation (Type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the last month) or previous history of suicide behavior Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| Placebo (single and multiple doses) | Drug | Placebo |
| AQW051 2 mg (single and multiple doses) | Drug | AQW051 Dose 1 |
| AQW051 15mg (single and multiple doses) | Drug | AQW051 Dose 2 |
| AQW051 100mg (single dose), and 50mg (multiple doses) | Drug | AQW051 Dose 3 |
Primary outcome
Effects of single oral doses of AQW051 versus placebo on cognitive function as measured by selected CogState tests
Time frame: 132 days Part A, 121 days Part B (screening to study completion)
4 secondary outcomes
Effects of single oral doses of AQW051 versus placebo on cognitive function as measured by selected MATRICS Consensus Cognitive Battery (MCCB) tests
Time frame: 132 days Part A, 121 days Part B (screening to study completion)
Effects of multiple oral doses of AQW051 versus placebo on cognitive function as measured by selected CogState tests and selected MCCB tests
Time frame: 132 days Part A, 121 days Part B (screening to study completion)
Correlation of the cognitive domains measured by MCCB versus CogState
Time frame: 132 days Part A, 121 days Part B (screening to study completion)
Pharmacokinetics, safety and tolerability of single and multiple doses of AQW051 as compared to placebo
Time frame: 132 days Part A, 121 days Part B (screening to study completion)
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 24 Dec 2020.
- Results for CAQW051A2205 from the Novartis Clinical Trials websiteLink provided by the sponsor.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AQW051 2 mg (single and multiple doses), AQW051 15mg (single and multiple doses) and AQW051 100mg (single dose), and 50mg (multiple doses) in people with Schizophrenia Disorders, run by Novartis Pharmaceuticals 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 4 inclusion and 5 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 24 Dec 2020. 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 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?
Effects of single oral doses of AQW051 versus placebo on cognitive function as measured by selected CogState tests (time frame: 132 days Part A, 121 days Part B (screening to study completion)). 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 24 Dec 2020.