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EpilepsyPhase 2NCT02351115

Staccato Alprazolam and Photoparoxysmal Response

A Phase 2 study testing B=Inhaled Alprazolam 0.5 mg, C=Inhaled Alprazolam 1 m and D= Inhaled Alprazolam 2 mg in people with Epilepsy, run by Nova Pneuma Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether people who usually have photosensitive epilepsy will show a reduction in epileptic activity when they take a single dose of Staccato Alprazolam as compared to placebo. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Epilepsy
What is being tested?
B=Inhaled Alprazolam 0.5 mg, C=Inhaled Alprazolam 1 m and D= Inhaled Alprazolam 2 mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
5 participants
Where
3 sitesUnited States
Study dates
Jan 2015to Jul 2016
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Male and female subjects between the ages of 18 to 60 years, inclusive
  • Body mass index (BMI) ≥18 and ≤35 kg/m2
  • Able to speak, read, and understand English and willing and able to provide written informed consent on an IRB-approved form before the initiation of any study procedures
  • A diagnosis and history of a photoparoxysmal response on EEG with or without a diagnosis of epilepsy for which patients are on 0-2 concomitant antiepileptic drugs
  • At least 3 of the EEGs performed during the screen visit must have a reproducible IPS-induced photoparoxysmal response (PPR) on EEG of at least 3 points on a frequency assessment scale in at least one eye condition
  • In otherwise good general health as determined by a complete medical history, physical examination, 12-lead ECG, blood chemistry profile, hematology, and urinalysis
  • Female participants (if of child-bearing potential and sexually active) and male participants (if sexually active with a partner of child-bearing potential) who agree to use a medically acceptable and effective birth control method throughout the study and for 1 week following the end of the study. Medically acceptable methods of contraception that may be used by the participant and/or his/her partner include abstinence, birth control pills or patches, diaphragm with spermicide, intrauterine device (IUD), surgical sterilization, and progestin implant or injection. Prohibited methods include: the rhythm method, withdrawal, condoms alone, or diaphragm alone

Who cannot join

  • History of non-epileptic seizures (e.g. metabolic, structural, or pseudo-seizures)
  • History of seizure worsening in response to narrow spectrum drugs
  • An active CNS infection, demyelinating disease, degenerative neurological disease or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results
  • Use of more than 2 concomitant AEDs for epilepsy treatment
  • Subjects taking known inhibitors or inducers of CYP3A , including carbamazepine
  • Subjects with a history of allergic reactions to alprazolam or other benzodiazepines
Show all 19Show fewer
  • Treatment with an investigational drug within 30 days (or within 5 half-lives of the investigational drug, if >30 days) before Visit 2
  • A history within the past 1 year of drug or alcohol dependence or abuse
  • Positive urine screen for drugs of abuse at Visit 1 - Screening
  • A history of HIV-positivity
  • Female subjects who have a positive pregnancy test at screening or prior to test sessions or are breastfeeding
  • History of acute narrow angle glaucoma, Parkinson's disease, hydrocephalus, or history of significant head trauma
  • Subjects who have a current history of asthma, chronic obstructive lung disease (COPD), or any lung disease associated with bronchospasm
  • Subjects who use medications to treat airways disease, such as asthma or COPD
  • Subjects who have any acute respiratory signs/symptoms (e.g., wheezing)
  • Clinically significant ECG abnormality including (but not limited to) any of the following conduction abnormalities or dysrhythmias: atrial fibrillation, mean QTcF (QT interval corrected for heart rate using Fridericia's method) interval >450 msec, ventricular rate <45 beats/min, second or third degree AV block, left bundle branch block, or evidence of prior myocardial infarction (MI) or acute ischemia
  • Hypotension (systolic blood pressure ≤90 mm Hg, diastolic blood pressure ≤50 mm Hg), or hypertension (systolic blood pressure ≥140 mm Hg, diastolic blood pressure ≥100 mm Hg) measured while seated at screening or baseline
  • Significant hepatic, renal, gastroenterologic, cardiovascular (including ischemic heart disease and congestive heart failure), endocrine, neurologic (including history of seizures or stroke), or hematologic disease
  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • Consultants in Epilepsy & Neurology, PLLC

    Boise, Idaho

  • New York University Epilepsy Center

    New York, New York

  • University of Pennsylvania - Penn Epilepsy Center

    Philadelphia, Pennsylvania

Other trials in United States

About this study

Official title: Assessment of Staccato® Alprazolam on the EEG Photoparoxysmal Response in Patients With Epilepsy

The purpose of this study is to determine whether people who usually have photosensitive epilepsy will show a reduction in epileptic activity when they take a single dose of Staccato Alprazolam as compared to placebo.

Read the detailed description

The purpose of this study is to determine whether people who usually have photosensitive epilepsy will show a reduction in epileptic activity when they take a single dose of Staccato Alprazolam as compared to placebo. People with photosensitive epilepsy have changes on their electroencephalogram (EEG) when shown flashing lights. Three dose levels of Staccato Alprazolam will be compared to placebo.

This study will also assess the level of sedation of Staccato Alprazolam compared to placebo.

Conditions
Epilepsy
Being tested
A=Placebo, B=Inhaled Alprazolam 0.5 mg, C=Inhaled Alprazolam 1 m, D= Inhaled Alprazolam 2 mg, E=Placebo
Medical subject headings
Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • A=PlaceboDrug

  • B=Inhaled Alprazolam 0.5 mgDrug

  • C=Inhaled Alprazolam 1 mDrug

  • D= Inhaled Alprazolam 2 mgDrug

  • E=PlaceboDrug

Study groups in NCT02351115
Study groupRoleWhat they receive
Sequence BEADCExperimentalA=Placebo, B=Inhaled Alprazolam 0.5 mg, C=Inhaled Alprazolam 1 mg, D= Inhaled Alprazolam 2 mg, E=Placebo
Receives: Drug: A=Placebo; Drug: B=Inhaled Alprazolam 0.5 mg; Drug: C=Inhaled Alprazolam 1 m; Drug: D= Inhaled Alprazolam 2 mg; Drug: E=Placebo
Sequence CDAEBExperimentalA=Placebo, B=Inhaled Alprazolam 0.5 mg, C=Inhaled Alprazolam 1 mg, D= Inhaled Alprazolam 2 mg, E=Placebo
Receives: Drug: A=Placebo; Drug: B=Inhaled Alprazolam 0.5 mg; Drug: C=Inhaled Alprazolam 1 m; Drug: D= Inhaled Alprazolam 2 mg; Drug: E=Placebo
Sequence DEBACExperimentalA=Placebo, B=Inhaled Alprazolam 0.5 mg, C=Inhaled Alprazolam 1 mg, D= Inhaled Alprazolam 2 mg, E=Placebo
Receives: Drug: A=Placebo; Drug: B=Inhaled Alprazolam 0.5 mg; Drug: C=Inhaled Alprazolam 1 m; Drug: D= Inhaled Alprazolam 2 mg; Drug: E=Placebo
Sequence EDBACExperimentalA=Placebo, B=Inhaled Alprazolam 0.5 mg, C=Inhaled Alprazolam 1 mg, D= Inhaled Alprazolam 2 mg, E=Placebo
Receives: Drug: A=Placebo; Drug: B=Inhaled Alprazolam 0.5 mg; Drug: C=Inhaled Alprazolam 1 m; Drug: D= Inhaled Alprazolam 2 mg; Drug: E=Placebo
Sequence CABEDExperimentalA=Placebo, B=Inhaled Alprazolam 0.5 mg, C=Inhaled Alprazolam 1 mg, D= Inhaled Alprazolam 2 mg, E=Placebo
Receives: Drug: A=Placebo; Drug: B=Inhaled Alprazolam 0.5 mg; Drug: C=Inhaled Alprazolam 1 m; Drug: D= Inhaled Alprazolam 2 mg; Drug: E=Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Observed Change From Pretreatment Baseline in the Standardized Photosensitivity Range (SPR)

    Photosensitivity describes the presentation of an epileptiform EEG response (photoparoxysmal response) from exposure to intermittent photic stimulation (IPS). SPR is the number of frequency steps (2, 5, 8, 10, 13, 15, 18, 20, 23, 25, 30, 40, 50 and 60 Hz). between the upper and lower limits of sensitivity to IPS for that patient at that time, in order not to evoke seizures. Thus a reduction (-change) means the intervention is working (desired effect on sensitivity)

    Measured: SPR was recorded pretreatment, 2, 10, 30 min, 1, 2, 4, and 6 hr post each study drug administration The maximum change from baseline occurred at: 10 min for alprazolam 2 mg, 1 hour for alprazolam 0.5 and 1 mg and placebo

Secondary outcomes (5)
  1. Maximum Sedation Using Visual Analog Scale (Sedated-Alert)

    Maximum change (in mm) from pretreatment baseline in level of sedation reported by the patient on a 100 mm line anchored by Sedated (0) and Alert (100)

    Measured: Sedation was recorded pretreatment, 2, 10, 30 min, 1, 2, 4, and 6 hr post each study drug administration The maximum change from baseline occurred at:: 30 min for alprazolam 1 mg, 1 hour for alprazolam 0.5 and 2 mg, and 4 hours for placebo

  2. Maximum Sedation Using Visual Analog Scale (Sleepy-Awake)

    Maximum change (in mm) from pretreatment baseline in level of sedation reported by each subject on a 100 mm line anchored by Sleepy (0) and Awake (100)

    Measured: Sleepiness was recorded pretreatment, 2, 10, 30 min, 1, 2, 4, and 6 hr post each study drug administration The maximum change from baseline occurred: at: 30 min for alprazolam 1 mg, 1 hour for alprazolam 0.5 and 2 mg and placebo

  3. Correlation of Plasma Concentrations of Alprazolam With Pharmacodynamic Effects on Standardized Photosensitivity Range (SPR)

    Pearson correlation of all paired plasma concentrations of alprazolam (PK) with pharmacodynamic effect on SPR (PD) for each alprazolam dose

    Measured: Pretreatment, 2, 10, 30 min, 1, 2, 4, and 6 hr post each study drug administration

  4. Correlation of Plasma Concentrations of Alprazolam With Pharmacodynamic Effects on Visual Analog Scale (Sedated-Alert)

    Pearson correlation of all paired plasma concentrations of alprazolam (PK) with pharmacodynamic effect on Sedation (PD) for each alprazolam dose

    Measured: Pretreatment, 2, 10, 30 min, 1, 2, 4, and 6 hr post each study drug administration

  5. Correlation of Plasma Concentrations of Alprazolam With Pharmacodynamic Effects on Visual Analog Scale (Sleepy-Awake)

    Pearson correlation of all paired plasma concentrations of alprazolam (PK) with pharmacodynamic effect on Sleepiness (PD) for each alprazolam dose

    Measured: Pretreatment, 2, 10, 30 min, 1, 2, 4, and 6 hr post each study drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02351115
Sponsor's protocol ID
AMDC-002-202
Status last verified
Apr 2026
First submitted
19 Jan 2015
Last updated
20 Apr 2026
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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing B=Inhaled Alprazolam 0.5 mg, C=Inhaled Alprazolam 1 m and D= Inhaled Alprazolam 2 mg in people with Epilepsy, run by Nova Pneuma 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 19 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 20 Apr 2026. 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. 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 10 Aug 2021). 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?

Maximum Observed Change From Pretreatment Baseline in the Standardized Photosensitivity Range (SPR) (time frame: SPR was recorded pretreatment, 2, 10, 30 min, 1, 2, 4, and 6 hr post each study drug administration The maximum change from baseline occurred at: 10 min for alprazolam 2 mg, 1 hour for alprazolam 0.5 and 1 mg and placebo). 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 20 Apr 2026.

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