Psychomotor AgitationPhase 3NCT04148963
A Study of Staccato Loxapine (ADASUVE®) for Inhalation
A Phase 3 study testing Inhaled loxapine in people with Psychomotor Agitation and Schizophrenia, run by Lee's Pharmaceutical Limited.
Trial summary
Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in schizophrenic or bipolar disorder patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychomotor Agitation, Schizophrenia, Bipolar Disorder
- What is being tested?
- Inhaled loxapine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2019to 1 Aug 2020
- Phase
- Phase 3
- 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
- 1. Male and female patients between the ages of 18 to 65 years, inclusive.
- 2. Patients who met Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for schizophrenia or bipolar disorder.
- 3. Patients are judged to be clinical mild to moderate agitation at baseline with a total value of ≥ 14, and have a score ≥4 on at least 1 of 5 items on the PANSS-EC scale, and with a value of ≥3 on CGI-S scale.
- 4. Patients are judged to be cooperative by the Investigator.
- 5. Written informed consent from patients (and/or legally acceptable representative, legally acceptable representative preferred) is obtained.
Who cannot join
- 1. Patients with agitation caused primarily by Delirium, Dpilepsy, Developmental Retardation, acute alcohol or psychoactive drugs intoxication/withdrawal symptoms (as per Investigator's judgment).
- 2. Patients judged to be at serious risk for suicide as per the Investigator's judgement.
- 3. Patients with a history of allergy or intolerance to loxapine or amoxapine.
- 4. Female patients of childbearing potential who have a positive urine pregnancy test at screening or breastfeeding.
- 5. Patients with acute respiratory signs/symptoms (e.g., wheezing) or with active airways disease (such as patients with asthma or chronic obstructive pulmonary disease).
- 6. Patients who are considered by the Investigator, for any reason, to be unsuitable candidates for receiving inhaled loxapine, or are likely to be unable to use the inhalation device.
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Staccato Loxapine (ADASUVE®) for Inhalation in Acutely Agitated Patients With Schizophrenia or Bipolar Disorder
Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in schizophrenic or bipolar disorder patients.
Read the detailed description
This is a multi-center, randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of Staccato Loxapine or placebo in treating acute agitation in patients with schizophrenia or bipolar disorder (manic or mixed episodes) as defined by DSM-V criteria.Patients may receive up to 3 doses of study drug in a 24-hour period, depending on their clinical status. The primary endpoint is the change from baseline in the PANSS (Positive and Negative Symptom Scale) Excited Component (also known as PEC) score, performed at 2 hours after the first dose.
- Conditions
- Psychomotor Agitation, Schizophrenia, Bipolar Disorder
- Being tested
- Inhaled loxapine, Inhaled placebo
- Keywords
- schizophrenia, bipolar disorder, agitation, inhaled loxapine, ADASUVE
- Medical subject headings
- Psychomotor Agitation, Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled loxapineDrug
Also called ADASUVE
Inhaled Loxapine 9.1 mg, may repeat x 1 or 2 after 2 hours
Inhaled placeboDrug
Inhaled placebo, may repeat x 1 or 2 after 2 hours
| Study group | Role | What they receive |
|---|---|---|
| Inhaled loxapine | Experimental | Inhaled Loxapine 9.1 mg, may repeat x 1 or 2 after 2 hours Receives: Drug: Inhaled loxapine |
| Inhaled placebo | Placebo comparator | Inhaled placebo, may repeat x 1 or 2 after 2 hours Receives: Drug: Inhaled placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PANSS-EC From Baseline
The Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (min) to 7 (max). The PANSS-EC, the sum of these 5 subscales, thus ranges from 5 to 35. Individuals were eligible if they had a PANSS-EC of ≥14 (out of 35) and a score ≥4 (out of 7) on at least 1 of the 5 items.
Measured: Time Frame: Baseline and 2 hours
Secondary outcomes (3)
Change in PANSS-EC From Baseline
Measured: Baseline and 30 minutes
Change in PANSS-EC From Baseline
Measured: Baseline and 4 hours
Change in PANSS-EC From Baseline
Measured: Baseline and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start1 Dec 2019 (estimated)
- Primary completion1 May 2020 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychomotor AgitationStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148963
- Sponsor's protocol ID
- ADS-ZK-2019
- Status last verified
- Jan 2019
- First submitted
- 31 Oct 2019
- Last updated
- 5 Nov 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Staccato Loxapine (ADASUVE®) for Inhalation in Acutely Agitated Patients With Schizophrenia or Bipolar Disorder
- ClinicalTrials.gov ID
- NCT04148963
- Acronym / sponsor ID
- ADS-ZK-2019
- Conditions
- Psychomotor Agitation, Schizophrenia, Bipolar Disorder
- Keywords
- schizophrenia, bipolar disorder, agitation, inhaled loxapine, ADASUVE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 4 Nov 2019 (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.
Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in schizophrenic or bipolar disorder patients.
Detailed description
This is a multi-center, randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of Staccato Loxapine or placebo in treating acute agitation in patients with schizophrenia or bipolar disorder (manic or mixed episodes) as defined by DSM-V criteria.Patients may receive up to 3 doses of study drug in a 24-hour period, depending on their clinical status. The primary endpoint is the change from baseline in the PANSS (Positive and Negative Symptom Scale) Excited Component (also known as PEC) score, performed at 2 hours after the first dose.
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 |
|---|---|---|
| Inhaled loxapine | Experimental | Drug: Inhaled loxapineInhaled Loxapine 9.1 mg, may repeat x 1 or 2 after 2 hours |
| Inhaled placebo | Placebo comparator | Drug: Inhaled placeboInhaled placebo, may repeat x 1 or 2 after 2 hours |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Male and female patients between the ages of 18 to 65 years, inclusive.
- 2. Patients who met Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for schizophrenia or bipolar disorder.
- 3. Patients are judged to be clinical mild to moderate agitation at baseline with a total value of ≥ 14, and have a score ≥4 on at least 1 of 5 items on the PANSS-EC scale, and with a value of ≥3 on CGI-S scale.
- 4. Patients are judged to be cooperative by the Investigator.
- 5. Written informed consent from patients (and/or legally acceptable representative, legally acceptable representative preferred) is obtained.
Key exclusion criteria (6 listed)
- 1. Patients with agitation caused primarily by Delirium, Dpilepsy, Developmental Retardation, acute alcohol or psychoactive drugs intoxication/withdrawal symptoms (as per Investigator's judgment).
- 2. Patients judged to be at serious risk for suicide as per the Investigator's judgement.
- 3. Patients with a history of allergy or intolerance to loxapine or amoxapine.
- 4. Female patients of childbearing potential who have a positive urine pregnancy test at screening or breastfeeding.
- 5. Patients with acute respiratory signs/symptoms (e.g., wheezing) or with active airways disease (such as patients with asthma or chronic obstructive pulmonary disease).
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 |
|---|---|---|
| Inhaled loxapineAlso: ADASUVEInhaled Loxapine 9.1 mg, may repeat x 1 or 2 after 2 hours | Drug | Inhaled loxapine |
| Inhaled placeboInhaled placebo, may repeat x 1 or 2 after 2 hours | Drug | Inhaled placebo |
Primary outcome
Change in PANSS-EC From Baseline
Time frame: Time Frame: Baseline and 2 hours
The Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (min) to 7 (max). The PANSS-EC, the sum of these 5 subscales, thus ranges from 5 to 35. Individuals were eligible if they had a PANSS-EC of ≥14 (out of 35) and a score ≥4 (out of 7) on at least 1 of the 5 items.
3 secondary outcomes
Change in PANSS-EC From Baseline
Time frame: Baseline and 30 minutes
Change in PANSS-EC From Baseline
Time frame: Baseline and 4 hours
Change in PANSS-EC From Baseline
Time frame: Baseline and 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inhaled loxapine in people with Psychomotor Agitation and Schizophrenia, run by Lee's Pharmaceutical Limited.
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 6 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: status not confirmed, as of the sponsor's last update on 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Change in PANSS-EC From Baseline (time frame: Time Frame: Baseline and 2 hours). 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 5 Nov 2019.