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Staccato Alprazolam and Photoparoxysmal Response

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ClinicalTrials.gov Identifier: NCT02351115
Recruitment Status : Completed
First Posted : January 30, 2015
Last Update Posted : March 15, 2017
Sponsor:
Collaborator:
The Epilepsy Study Consortium
Information provided by (Responsible Party):
Alexza Pharmaceuticals, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Staccato® Alprazolam, 0.5 mg Drug: Staccato® Alprazolam, 1 mg Drug: Staccato® Alprazolam, 2 mg Drug: Staccato® Placebo (a) Drug: Staccato® Placebo (b) Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of Staccato® Alprazolam on the EEG Photoparoxysmal Response in Patients With Epilepsy
Study Start Date : January 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
Drug Information available for: Alprazolam

Arm Intervention/treatment
Experimental: Staccato® Alprazolam, 0.5 mg
Single-dose Staccato® Alprazolam for Inhalation, 0.5 mg
Drug: Staccato® Alprazolam, 0.5 mg
Experimental: Staccato® Alprazolam, 1 mg
Single-dose Staccato® Alprazolam for Inhalation, 1 mg
Drug: Staccato® Alprazolam, 1 mg
Experimental: Staccato® Alprazolam, 2 mg
Single-dose Staccato® Alprazolam for Inhalation, 2 mg
Drug: Staccato® Alprazolam, 2 mg
Placebo Comparator: Staccato® Placebo (a)
Single-dose inhaled Staccato® Placebo, Inhaler with no drug
Drug: Staccato® Placebo (a)
Placebo Comparator: Staccato® Placebo (b)
Single-dose inhaled Staccato® Placebo, Inhaler with no drug
Drug: Staccato® Placebo (b)



Primary Outcome Measures :
  1. Change in the photosensitivity response in subjects receiving Staccato® Alprazolam as compared to placebo [ Time Frame: 2 min, 10 min, 30 min, 1 hr, 2 hr, 4 hr, and 6 hr post study drug administration ]
    Changes in the photosensitivity response will be measured by assessing changes in the subjects EEG activity when shown flashing lights.


Secondary Outcome Measures :
  1. Assessment of sedation using 2 visual analogue scales [ Time Frame: 2 min, 10 min, 30 min, 1 hr, 2 hr, 4 hr, and 6 hr post study drug administration ]
    Level of sedation will be measured using 2 visual analogue scales

  2. Correlation of plasma concentrations of Staccato® Alprazolam with pharmacodynamic effects on photosensitivity response [ Time Frame: 2 min, 10 min, 30 min, 1 hr, 2 hr, 4 hr, and 6 hr post study drug administration ]
    The relationship between pharmacokinetic parameters including maximum concentration (Cmax), time to maximum (Tmax) and area under the concentration curve (AUC) will be compared to the photosensitivity response measured by assessing EEG activity changes when shown flashing lights.

  3. Correlation of plasma concentrations of Staccato® Alprazolam with pharmacodynamic effects on sedation [ Time Frame: 2 min, 10 min, 30 min, 1 hr, 2 hr, 4 hr, and 6 hr post study drug administration ]
    The relationship between pharmacokinetic parameters including maximum concentration (Cmax), time to maximum (Tmax) and area under the concentration curve (AUC) will be compared to the sedation effects of Staccato® Alprazolam measured using 2 visual analogue scales.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02351115


Locations
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United States, Idaho
Consultants in Epilepsy & Neurology, PLLC
Boise, Idaho, United States
United States, New York
New York University Epilepsy Center
New York, New York, United States
United States, Pennsylvania
University of Pennsylvania - Penn Epilepsy Center
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
Alexza Pharmaceuticals, Inc.
The Epilepsy Study Consortium

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Responsible Party: Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02351115     History of Changes
Other Study ID Numbers: AMDC-002-202
First Posted: January 30, 2015    Key Record Dates
Last Update Posted: March 15, 2017
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Alprazolam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action