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Staccato® Alprazolam and EEG Photoparoxysmal Response

Information source: Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: Staccato® Alprazolam, 0.5 mg (Drug); Staccato® Alprazolam, 1 mg (Drug); Staccato® Alprazolam, 2 mg (Drug); Staccato® Placebo (a) (Drug); Staccato® Placebo (b) (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Alexza Pharmaceuticals, Inc.

Overall contact:
Alexza Pharmaceuticals, Inc., Phone: 650-944-7000

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. 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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in the photosensitivity response in subjects receiving Staccato® Alprazolam as compared to placebo

Secondary outcome:

Assessment of sedation using 2 visual analogue scales

Correlation of plasma concentrations of Staccato® Alprazolam with pharmacodynamic effects on photosensitivity response

Correlation of plasma concentrations of Staccato® Alprazolam with pharmacodynamic effects on sedation

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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

Locations and Contacts

Alexza Pharmaceuticals, Inc., Phone: 650-944-7000

Consultants in Epilepsy & Neurology, PLLC, Boise, Idaho, United States; Recruiting
Robert T Wechsler, MD, PhD

New York University Epilepsy Center, New York, New York, United States; Recruiting
Blanca Vazquez, MD

University of Pennsylvania - Penn Epilepsy Center, Philadelphia, Pennsylvania, United States; Recruiting
John Pollard, MD

Additional Information

Starting date: January 2015
Last updated: August 12, 2015

Page last updated: August 23, 2015

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