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CompletedNCT00477451Updated Jun 16, 2017Results posted

Staccato Alprazolam in Panic Attack

A Phase 2 interventional study of Inhaled placebo and Inhaled alprazolam 1 mg in Treatment of Induced Panic Attack, sponsored by Alexza Pharmaceuticals, Inc.. Completed at 3 sites in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2017-06-16.

Sponsored by Alexza Pharmaceuticals, Inc. (part of Ferrer Internacional S.A.) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Treatment of Induced Panic Attack

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Keywords

  • Staccato™ Alprazolam, Panic Attack, Inhaled alprazolam
03

In context

Panic Disorder

256 studies on the registry are indexed under Panic Disorder; 35 are open to participants now.

This study's enrollment of 49 is below the median of 78 across 201 interventional studies indexed under Panic Disorder.

Browse Panic Disorder studies →

Lead sponsor

Alexza Pharmaceuticals, Inc. is the lead sponsor of 26 studies on the registry; none are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 14 (58%) have results posted.

First submitted before Alexza Pharmaceuticals, Inc. became part of Ferrer Internacional S.A..

Browse Alexza Pharmaceuticals, Inc. studies →All Ferrer Internacional S.A. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subjects who meet DSM-IV criteria for panic disorder, with or without agoraphobia.
  2. 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).
  3. Male or female subjects who are English-speaking between 18 and 55 years of age.
  4. 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).
  5. Subjects who are medically healthy (i.e. without a clinically significant unstable medical condition such as asthma, coronary artery disease, renal insufficiency, etc.)
  6. Subjects who are able to give informed consent for participation.
  7. Subjects who are able to be withdrawn from current panic disorder medication because it is ineffective.

Exclusion criteria

Exclusion Criteria:

  1. Subjects who have met DSM-IV criteria for substance abuse or dependence within six months of study entry must be excluded.
  2. Subjects with a baseline Acute Panic Inventory (22 item test) score of 41 or higher on the test day must be excluded.
  3. 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.
  4. Subjects who are clinically depressed must be excluded.
  5. 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.
  6. Subjects with epilepsy or other convulsive disorders must be excluded.
  7. Subjects with a history of allergy or intolerance to benzodiazepines or related drugs (alprazolam, lorazepam, diazepam, etizolam, clonazepam, adinazolam) must be excluded.
  8. 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.
  9. Female subjects who are breastfeeding or have a positive pregnancy test must be excluded.
  10. 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
49 participants (actual)

Study arms

  • Placebo comparator
    RCT Placebo

    Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial

    Drug: Inhaled placebo · Drug: IV doxapram

  • Experimental
    RCT Alprazolam 1 mg

    Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial

    Drug: Inhaled alprazolam 1 mg · Drug: IV doxapram

  • Experimental
    Open Label Inhaled Alprazolam 1 mg

    Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the open label dose validation

    Drug: Inhaled alprazolam 1 mg · Drug: IV doxapram

  • Experimental
    Initial Inhaled Alprazolam 2 mg

    Subjects received 2 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the initial open label dose assessment

    Drug: Inhaled alprazolam 2 mg · Drug: IV doxapram

Interventions

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 0 to 2 hours

  2. 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)

    Time frame: 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

    Time frame: 45 minutes

07

Results

Posted Jun 16, 2017

Participant flow

Participant flow — Overall Study
MilestoneRCT PlaceboRCT Alprazolam 1 mgOpen Label Inhaled Alprazolam 1 mgInitial Inhaled Alprazolam 2 mg
Started202072
Completed202072
Not completed0000

Outcome measures

PrimaryNumber 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)

Time frame:
0 to 2 hours
Reported as:
Count of participants · Participants
Number of Participants With Doxapram-induced Panic Attack
ParticipantsRCT PlaceboRCT Alprazolam 1 mg
Number of Participants With Doxapram-induced Panic Attack149
Statistical analysis
  • RCT Placebo vs RCT Alprazolam 1 mg · Fisher Exact · p = 0.200
PrimaryDuration 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)

Time frame:
1 hr post-dose
Reported as:
Mean · minutes
Duration of the Doxapram-induced Panic Attack
minutesRCT PlaceboRCT Alprazolam 1 mg
Duration of the Doxapram-induced Panic Attack12.2 ± 17.29.25 ± 14.1
Statistical analysis
  • RCT Placebo vs RCT Alprazolam 1 mg · Wilcoxon (Mann-Whitney) · p = 0.368
SecondaryBorg 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

Time frame:
45 minutes
Reported as:
Mean · units on a scale
Borg Max Change From Baseline
units on a scaleRCT PlaceboRCT Alprazolam 1 mg
Borg Max Change From Baseline5.73 ± 2.854.63 ± 2.56
Statistical analysis
  • RCT Placebo vs RCT Alprazolam 1 mg · t-test, 2 sided · p = 0.207

Adverse events

Collected over Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
RCT Placebo0/20 (0%)0/20 (0%)2/20 (10%)
RCT Alprazolam 1 mg0/20 (0%)0/20 (0%)11/20 (55%)
Open Label Inhaled Alprazolam 1 mg0/7 (0%)0/7 (0%)1/7 (14.3%)
Initial Inhaled Alprazolam 2 mg0/2 (0%)0/2 (0%)1/2 (50%)
Most frequent other events
Most frequent other events
EventRCT PlaceboRCT Alprazolam 1 mgOpen Label Inhaled Alprazolam 1 mgInitial Inhaled Alprazolam 2 mg
VomitingGastrointestinal disorders0/201/200/71/2
DizzinessNervous system disorders0/200/200/71/2
SEDATIONNervous system disorders2/209/201/71/2
DysgeusiaGastrointestinal disorders1/204/200/70/2
HYPOAESTHESIANervous system disorders1/200/200/70/2
COUGHRespiratory, thoracic and mediastinal disorders0/201/200/70/2

Baseline characteristics

Safety Population

Age, Categorical
Age, Categorical(Participants)RCT PlaceboRCT Alprazolam 1 mgOpen Label Inhaled Alprazolam 1 mgInitial Inhaled Alprazolam 2 mgTotal
<=18 years00000
Between 18 and 65 years20207249
>=65 years00000
Age, Continuous
Age, Continuous(years)RCT PlaceboRCT Alprazolam 1 mgOpen Label Inhaled Alprazolam 1 mgInitial Inhaled Alprazolam 2 mgTotal
Mean33.2 ± 10.232.1 ± 9.4543.1 ± 13.637.5 ± 0.70734.3 ± 10.66
Sex: Female, Male
Sex: Female, Male(Participants)RCT PlaceboRCT Alprazolam 1 mgOpen Label Inhaled Alprazolam 1 mgInitial Inhaled Alprazolam 2 mgTotal
Female9121123
Male1186126
Region of Enrollment
Region of Enrollment(Participants)RCT PlaceboRCT Alprazolam 1 mgOpen Label Inhaled Alprazolam 1 mgInitial Inhaled Alprazolam 2 mgTotal
United States20207249
08

Study locations

3 sites
  • SUNY Downstate Medical Center
    Brooklyn, New York 11203-2056, United States
  • New York State Psychiatric Institute
    New York, New York 10021, United States
  • Mt. Sinai School Of Medicine
    New York, New York 10029, United States
09

References and documents

Individual participant data

Plan to share: Yes — IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2007 to primary completion in Apr 2008, 11 months.

Results were first posted in Jun 2017, 9 years 2 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
May 22, 2007
First posted
May 23, 2007
StartActual
May 2007
Primary completionActual
Apr 2008
CompletionActual
Apr 2008
Results first posted
Jun 16, 2017
Last update
Jun 16, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00477451
Lead sponsor
Alexza Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
May 23, 2007
Start date
May 2007
Primary completion
Apr 2008
Completion
Apr 2008
Results posted
Jun 16, 2017
Last update
Jun 16, 2017

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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