Treatment of Induced Panic AttackPhase 2NCT00477451
Staccato Alprazolam in Panic Attack
A Phase 2 study testing Inhaled alprazolam 1 mg, Inhaled alprazolam 2 mg and IV doxapram in people with Treatment of Induced Panic Attack, run by Alexza Pharmaceuticals, Inc. at 3 sites in United States.
Trial summary
We are developing Staccato™ Alprazolam for the treatment of Panic attacks associated with panic disorder. This study will provide an initial assessment of efficacy, and to continue to describe the tolerability and pharmacokinetics, of a single inhaled dose of Staccato Alprazolam on a doxapram-induced panic attack in… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Treatment of Induced Panic Attack
- What is being tested?
- Inhaled alprazolam 1 mg, Inhaled alprazolam 2 mg and IV doxapram
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2007to Apr 2008
- Phase
- Phase 2
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects who meet DSM-IV criteria for panic disorder, with or without agoraphobia.
- Subjects who have had at least one panic attack per week in each of the four weeks prior to the start of treatment and/or have a Mobility Inventory Score of 3.3 (alone) or 2.5 (accompanied).
- Male or female subjects who are English-speaking between 18 and 55 years of age.
- Female subjects who are not pregnant, or are surgically sterile or 2 years postmenopausal. If of childbearing potential, she must be using a medically-accepted method of birth control and agree to continue use of this method for at least 30 days after the study (i.e., barrier method with spermicide, steroidal contraceptive [oral, transdermal, and implanted, including Depo-Provera; contraceptives must be used in conjunction with a barrier method], or intrauterine device).
- Subjects who are medically healthy (i.e. without a clinically significant unstable medical condition such as asthma, coronary artery disease, renal insufficiency, etc.)
- Subjects who are able to give informed consent for participation.
- Subjects who are able to be withdrawn from current panic disorder medication because it is ineffective.
Who cannot join
- Subjects who have met DSM-IV criteria for substance abuse or dependence within six months of study entry must be excluded.
- Subjects with a baseline Acute Panic Inventory (22 item test) score of 41 or higher on the test day must be excluded.
- Subjects who are taking benzodiazepines, SSRIs, or medication that is effective for the prevention or treatment of the patient's panic disorder (i.e., no patient will be withdrawn for medication that is working for the purpose of entry into this study) must be excluded.
- Subjects who are clinically depressed must be excluded.
- Subjects who have received an investigational drug within 30 days (or within 5 half lives of the investigational drug) prior to test day must be excluded.
- Subjects with epilepsy or other convulsive disorders must be excluded.
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- Subjects with a history of allergy or intolerance to benzodiazepines or related drugs (alprazolam, lorazepam, diazepam, etizolam, clonazepam, adinazolam) must be excluded.
- Subjects who test positive for alcohol or have a positive urine drug screen for illicit or disallowed drugs must be excluded. Subjects should refrain from consuming alcohol for at least 48 hours prior to dosing.
- Female subjects who are breastfeeding or have a positive pregnancy test must be excluded.
- Subjects who have any other disease or condition, by history, physical examination, or laboratory abnormalities that in the investigator's opinion, would present undue risk to the subject, or may confound the interpretation of study results must be excluded.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
SUNY Downstate Medical Center
Brooklyn, New York, 11203-2056
New York State Psychiatric Institute
New York, New York, 10021
Mt. Sinai School Of Medicine
New York, New York, 10029
About this study
Official title: Investigation of a Single Dose of Staccato™ Alprazolam for Inhalation on Doxapram-Induced Panic Attack in Patients With Panic Disorder
We are developing Staccato™ Alprazolam for the treatment of Panic attacks associated with panic disorder. This study will provide an initial assessment of efficacy, and to continue to describe the tolerability and pharmacokinetics, of a single inhaled dose of Staccato Alprazolam on a doxapram-induced panic attack in patients with panic disorder.
Read the detailed description
The study will be conducted at multiple centers. A total of 42 male and female panic disorder patients will be studied. The first 6 subjects will receive Staccato Alprazolam 1 mg open label to validate the dose selection. The remaining 36 subjects will be treated with either Staccato Alprazolam at the chosen dose; or with Staccato Placebo in a double blind, randomized order.
- Conditions
- Treatment of Induced Panic Attack
- Being tested
- Inhaled placebo, Inhaled alprazolam 1 mg, Inhaled alprazolam 2 mg, IV doxapram
- Keywords
- Staccato™ Alprazolam, Panic Attack, Inhaled alprazolam
- Medical subject headings
- Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled placeboDrug
Inhaled Staccato Alprazolam Placebo
Inhaled alprazolam 1 mgDrug
Inhaled Staccato Alprazolam 1 mg
Inhaled alprazolam 2 mgDrug
Inhaled Staccato Alprazolam 2 mg
IV doxapramDrug
0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo
| Study group | Role | What they receive |
|---|---|---|
| RCT Placebo | Placebo comparator | Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial Receives: Drug: Inhaled placebo; Drug: IV doxapram |
| RCT Alprazolam 1 mg | Experimental | Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial Receives: Drug: Inhaled alprazolam 1 mg; Drug: IV doxapram |
| Open Label Inhaled Alprazolam 1 mg | Experimental | Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the open label dose validation Receives: Drug: Inhaled alprazolam 1 mg; Drug: IV doxapram |
| Initial Inhaled Alprazolam 2 mg | Experimental | Subjects received 2 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the initial open label dose assessment Receives: Drug: Inhaled alprazolam 2 mg; Drug: IV doxapram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Doxapram-induced Panic Attack
doxapram-induced panic attack of sufficient intensity (DIPASI) defined as a 10 or greater increase from baseline in the acute panic inventory (API)
Measured: 0 to 2 hours
Duration of the Doxapram-induced Panic Attack
Length of time from the doxapram injection to the time at which the acute panic inventory (API) value returns to within 10 points of the baseline API value. 0=never exceeded 0, 61=exceeded by more than 10 points still at end of assessment of 60 minutes. Thus each would have a duration whether or not they had a panic attack (DIPASI)
Measured: 1 hr post-dose
Secondary outcomes (1)
Borg Max Change From Baseline
Subjects asked to "Point to the number (0 to 10) which matches how breathless you feel now" where 0=nothing at all to 10=very, very strong
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2007 (estimated)
- Study startMay 2007
- Primary completionApr 2008
- Study completionApr 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.
- Other trials for Treatment of Induced Panic AttackStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Sanjay Mathew, MD, Principal investigator, Mt. Sinai School of MedicineJeremy Coplan, MD, Principal investigator, State University of New York - Downstate Medical CenterLaszlo Papp, MD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477451
- Sponsor's protocol ID
- AMDC-002-201
- Status last verified
- Jun 2008
- First submitted
- 22 May 2007
- Last updated
- 16 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of a Single Dose of Staccato™ Alprazolam for Inhalation on Doxapram-Induced Panic Attack in Patients With Panic Disorder
- ClinicalTrials.gov ID
- NCT00477451
- Acronym / sponsor ID
- AMDC-002-201
- Conditions
- Treatment of Induced Panic Attack
- Keywords
- Staccato™ Alprazolam, Panic Attack, Inhaled alprazolam
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Study start
- May 2007 (actual)
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 23 May 2007 (estimated)
- Results
- Posted 16 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We are developing Staccato™ Alprazolam for the treatment of Panic attacks associated with panic disorder. This study will provide an initial assessment of efficacy, and to continue to describe the tolerability and pharmacokinetics, of a single inhaled dose of Staccato Alprazolam on a doxapram-induced panic attack in patients with panic disorder.
Detailed description
The study will be conducted at multiple centers. A total of 42 male and female panic disorder patients will be studied. The first 6 subjects will receive Staccato Alprazolam 1 mg open label to validate the dose selection. The remaining 36 subjects will be treated with either Staccato Alprazolam at the chosen dose; or with Staccato Placebo in a double blind, randomized order.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RCT Placebo | Placebo comparator | Drug: Inhaled placebo, Drug: IV doxapramSubjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial |
| RCT Alprazolam 1 mg | Experimental | Drug: Inhaled alprazolam 1 mg, Drug: IV doxapramSubjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial |
| Open Label Inhaled Alprazolam 1 mg | Experimental | Drug: Inhaled alprazolam 1 mg, Drug: IV doxapramSubjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the open label dose validation |
| Initial Inhaled Alprazolam 2 mg | Experimental | Drug: Inhaled alprazolam 2 mg, Drug: IV doxapramSubjects received 2 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the initial open label dose assessment |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects who meet DSM-IV criteria for panic disorder, with or without agoraphobia.
- Subjects who have had at least one panic attack per week in each of the four weeks prior to the start of treatment and/or have a Mobility Inventory Score of 3.3 (alone) or 2.5 (accompanied).
- Male or female subjects who are English-speaking between 18 and 55 years of age.
- Female subjects who are not pregnant, or are surgically sterile or 2 years postmenopausal. If of childbearing potential, she must be using a medically-accepted method of birth control and agree to continue use of this method for at least 30 days after the study (i.e., barrier method with spermicide, steroidal contraceptive [oral, transdermal, and implanted, including Depo-Provera; contraceptives must be used in conjunction with a barrier method], or intrauterine device).
- Subjects who are medically healthy (i.e. without a clinically significant unstable medical condition such as asthma, coronary artery disease, renal insufficiency, etc.)
Key exclusion criteria (10 listed)
- Subjects who have met DSM-IV criteria for substance abuse or dependence within six months of study entry must be excluded.
- Subjects with a baseline Acute Panic Inventory (22 item test) score of 41 or higher on the test day must be excluded.
- Subjects who are taking benzodiazepines, SSRIs, or medication that is effective for the prevention or treatment of the patient's panic disorder (i.e., no patient will be withdrawn for medication that is working for the purpose of entry into this study) must be excluded.
- Subjects who are clinically depressed must be excluded.
- Subjects who have received an investigational drug within 30 days (or within 5 half lives of the investigational drug) prior to test day must be excluded.
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 placeboInhaled Staccato Alprazolam Placebo | Drug | RCT Placebo |
| Inhaled alprazolam 1 mgInhaled Staccato Alprazolam 1 mg | Drug | Open Label Inhaled Alprazolam 1 mg, RCT Alprazolam 1 mg |
| Inhaled alprazolam 2 mgInhaled Staccato Alprazolam 2 mg | Drug | Initial Inhaled Alprazolam 2 mg |
| IV doxapram0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo | Drug | Initial Inhaled Alprazolam 2 mg, Open Label Inhaled Alprazolam 1 mg, RCT Alprazolam 1 mg, RCT Placebo |
Primary outcome
Number of Participants With Doxapram-induced Panic Attack
Time frame: 0 to 2 hours
doxapram-induced panic attack of sufficient intensity (DIPASI) defined as a 10 or greater increase from baseline in the acute panic inventory (API)
Duration of the Doxapram-induced Panic Attack
Time frame: 1 hr post-dose
Length of time from the doxapram injection to the time at which the acute panic inventory (API) value returns to within 10 points of the baseline API value. 0=never exceeded 0, 61=exceeded by more than 10 points still at end of assessment of 60 minutes. Thus each would have a duration whether or not they had a panic attack (DIPASI)
1 secondary outcome
Borg Max Change From Baseline
Time frame: 45 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
Sanjay Mathew, MD principal investigator
Mt. Sinai School of Medicine
Jeremy Coplan, MD principal investigator
State University of New York - Downstate Medical Center
Laszlo Papp, MD principal investigator
New York State Psychiatric Institute
3 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 Inhaled alprazolam 1 mg, Inhaled alprazolam 2 mg and IV doxapram in people with Treatment of Induced Panic Attack, run by Alexza Pharmaceuticals, Inc. at 3 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 7 inclusion and 10 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 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 16 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?
Number of Participants With Doxapram-induced Panic Attack (time frame: 0 to 2 hours). The study lists 2 primary outcomes in all. 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 16 Jun 2017; AzTrials last refreshed its copy on 27 Oct 2026.