Patients With Schizophrenia and Acute AgitationPhase 3NCT00628589
Staccato Loxapine in Agitated Patients With Schizophrenia
A Phase 3 study testing Inhaled loxapine 5 mg and Inhaled loxapine 10 mg in people with Patients With Schizophrenia and Acute Agitation, run by Alexza Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in schizophrenic patients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Patients With Schizophrenia and Acute Agitation
- What is being tested?
- Inhaled loxapine 5 mg and Inhaled loxapine 10 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 344 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to May 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male and female adult patients with schizophrenia and acute agitation
Who cannot join
- Agitation caused primarily by acute intoxication
- History of drug or alcohol dependence
- Treatment with benzodiazepines or other hypnotics within 4 hours prior to study drug administration
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlanta Center for Medical Research
Atlanta, Georgia, 30308
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multi-Dose Efficacy and Safety Study of Staccato® Loxapine for Inhalation in Schizophrenic Patients With Agitation
Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in schizophrenic patients
Read the detailed description
This is an in-clinic, multi-center, randomized, double-blind, placebo-controlled study of 2 dose levels of Staccato Loxapine, 5 and 10 mg. 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.
- Being tested
- Inhaled loxapine 5 mg, Inhaled loxapine 10 mg, Inhaled placebo
- Keywords
- schizophrenia, agitation, inhaled loxapine, ADASUVE
- Medical subject headings
- Schizophrenia, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled loxapine 5 mgDrug
Also called ADASUVE
Inhaled loxapine 5 mg
Inhaled loxapine 10 mgDrug
Also called ADASUVE
Inhaled loxapine 10 mg
Inhaled placeboDrug
Inhaled placebo
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Loxapine 5 mg | Experimental | Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours Receives: Drug: Inhaled loxapine 5 mg |
| Inhaled Loxapine 10 mg | Experimental | Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours Receives: Drug: Inhaled loxapine 10 mg |
| Inhaled placebo | Placebo comparator | Inhaled Loxapine 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: Baseline and 2 hours
Secondary outcomes (2)
Clinical Global Impression-Improvement (CGI-I) Score
Clinical Global Impression- Improvement (CGI-I) scores ranged from 1 to 7: 0=not assessed (missing), 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.
Measured: Baseline and 2 hours
CGI-I Responders
Frequency of response based on the CGI-I (defined as achieving a CGI-I score of 1 or 2 at 2 hours after administration of the inhalation)
Measured: Baseline and 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patients With Schizophrenia and Acute 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
- 344 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Robert S Fishman, MD, Study director, Alexza Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628589
- Sponsor's protocol ID
- AMDC-004-301
- Status last verified
- Jun 2008
- First submitted
- 25 Feb 2008
- Last updated
- 26 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com
Publications
Lesem MD, Tran-Johnson TK, Riesenberg RA, Feifel D, Allen MH, Fishman R, Spyker DA, Kehne JH, Cassella JV. Rapid acute treatment of agitation in individuals with schizophrenia: multicentre, randomised, placebo-controlled study of inhaled loxapine. Br J Psychiatry. 2011 Jan;198(1):51-8. doi: 10.1192/bjp.bp.110.081513.
PubMed 21200077Zeller S, Zun L, Cassella JV, Spyker DA, Yeung PP. Response to inhaled loxapine in patients with schizophrenia or bipolar I disorder: PANSS-EC responder analyses. BJPsych Open. 2017 Nov 10;3(6):285-290. doi: 10.1192/bjpo.bp.117.005363. eCollection 2017 Nov.
PubMed 29163985
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multi-Dose Efficacy and Safety Study of Staccato® Loxapine for Inhalation in Schizophrenic Patients With Agitation
- ClinicalTrials.gov ID
- NCT00628589
- Acronym / sponsor ID
- AMDC-004-301
- Keywords
- schizophrenia, agitation, inhaled loxapine, ADASUVE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Study start
- Feb 2008
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 5 Mar 2008 (estimated)
- Results
- Posted 29 Jun 2017
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 patients
Detailed description
This is an in-clinic, multi-center, randomized, double-blind, placebo-controlled study of 2 dose levels of Staccato Loxapine, 5 and 10 mg. 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Inhaled Loxapine 5 mg | Experimental | Drug: Inhaled loxapine 5 mgInhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours |
| Inhaled Loxapine 10 mg | Experimental | Drug: Inhaled loxapine 10 mgInhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours |
| Inhaled placebo | Placebo comparator | Drug: Inhaled placeboInhaled Loxapine 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 (1 listed)
- Male and female adult patients with schizophrenia and acute agitation
Key exclusion criteria (3 listed)
- Agitation caused primarily by acute intoxication
- History of drug or alcohol dependence
- Treatment with benzodiazepines or other hypnotics within 4 hours prior to study drug administration
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 loxapine 5 mgAlso: ADASUVEInhaled loxapine 5 mg | Drug | Inhaled Loxapine 5 mg |
| Inhaled loxapine 10 mgAlso: ADASUVEInhaled loxapine 10 mg | Drug | Inhaled Loxapine 10 mg |
| Inhaled placeboInhaled placebo | Drug | Inhaled placebo |
Primary outcome
Change in PANSS-EC From Baseline
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.
2 secondary outcomes
Clinical Global Impression-Improvement (CGI-I) Score
Time frame: Baseline and 2 hours
CGI-I Responders
Time frame: Baseline and 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21200077Lesem MD, Tran-Johnson TK, Riesenberg RA, Feifel D, Allen MH, Fishman R, Spyker DA, Kehne JH, Cassella JV. Rapid acute treatment of agitation in individuals with schizophrenia: multicentre, randomised, placebo-controlled study of inhaled loxapine. Br J Psychiatry. 2011 Jan;198(1):51-8. doi: 10.1192/bjp.bp.110.081513.
- Derived from this study: PubMed 29163985Zeller S, Zun L, Cassella JV, Spyker DA, Yeung PP. Response to inhaled loxapine in patients with schizophrenia or bipolar I disorder: PANSS-EC responder analyses. BJPsych Open. 2017 Nov 10;3(6):285-290. doi: 10.1192/bjpo.bp.117.005363. eCollection 2017 Nov.
- Individual participant dataSharing planned: No. IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com
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.
Robert S Fishman, MD study director
Alexza Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inhaled loxapine 5 mg and Inhaled loxapine 10 mg in people with Patients With Schizophrenia and Acute Agitation, run by Alexza Pharmaceuticals, Inc. 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 1 inclusion and 3 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 26 Jul 2017. 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 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?
Yes. Results are posted in the registry (first posted 29 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: Baseline and 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00628589, which also lists 2 linked publications.
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 26 Jul 2017.