Inpatient, Dose-Ranging Study of Staccato Alprazolam in Epilepsy With Predictable Seizure Pattern



Status:Recruiting
Conditions:Neurology, Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - Any
Updated:3/23/2019
Start Date:March 16, 2018
End Date:August 2019
Contact:Director
Email:studydirector@engagetherapeutics.com
Phone:908-873-7138

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A Double-Blind, Placebo-Controlled, Inpatient, Dose-Ranging Efficacy Study of Staccato Alprazolam (STAP-001) in Subjects With Epilepsy With a Predictable Seizure Pattern

This is a multi-center, double-blind, randomized, parallel group, dose-ranging study to
investigate the efficacy and clinical usability of STAP-001 in adult (18 years of age and
older) subjects with epilepsy with a predictable seizure pattern. These subjects have an
established diagnosis of focal or generalized epilepsy with a documented history of
predictable seizure episodes. This is an in-patient study. The subjects will be admitted to a
Clinical Research Unit (CRU) or Epilepsy Monitoring Unit (EMU) for study participation. The
duration of the stay in the in-patient unit will be 2-8 days. One seizure event per subject
will be treated with study medication. The duration and timing of the seizure event and
occurrence of subsequent seizures will be assessed by the Staff Caregiver(s)1 through
clinical observation and confirmed with video electroencephalogram (EEG).


Inclusion Criteria:

1. Subject is able to provide, personally signed, and dated informed consent to
participate in the study or will have a legally authorized representative sign the
informed consent on his or her behalf before completing any study related procedures.

2. Male or female ≥ 18 years of age.

3. Has an established diagnosis of focal or generalized epilepsy or focal and generalized
epilepsy with a documented history of predictable seizure episodes that includes at
least one of the following:

- Generalized seizure episodes starting with a flurry of absence seizures or
myoclonic seizures with a minimum duration of 5 minutes

- Episodes of a prolonged focal seizure with a minimum duration of 3 minutes

- Episodes of multiple (≥2) seizures within a 2-hour time period

4. Prior to randomization, has experienced ≥4 seizure episodes with predictable pattern
during the last 4 weeks (qualification period) and no more than one week without a
predictable seizure episode before entry into the in-patient unit.

5. 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.

6. Subject is able to comply by the requirements of the protocol, particularly the
requirements and specific Institution policies during the in-clinic stay.

Exclusion Criteria:

1. History or diagnosis of non-epileptic seizures (e.g. metabolic or pseudo-seizures).

2. History of status epilepticus in the 6 months prior to Screening

3. Has a progressive neurological disorder such as brain tumor, demyelinating disease, or
degenerative central nervous system (CNS) disease that is likely to progress in the
next 3 months

4. Use of strong CYP 3A4 inhibitors; including azole antifungal agents (e.g.,
etoconazole, itraconazole), nefazodone, fluvoxamine, cimetidine, HIV protease
inhibitors (e.g., ritonavir)

5. Has severe chronic cardio-respiratory disease

6. History of HIV-positivity.

7. Pregnant or breast-feeding.

8. Clinically significant renal or hepatic insufficiency (hepatic transaminases >2 times
the upper limit of normal (ULN) or creatinine ≥ 1.5 x ULN).

9. History of acute narrow angle glaucoma, Parkinson's disease, hydrocephalus, or history
of significant head trauma.

10. Subjects who use medications to treat airways disease, such as asthma or COPD or have
any acute respiratory signs/symptoms (e.g., wheezing).

11. Use of any investigational drug within 30 days or 5 half-lives of the investigational
drug prior to administration of study medication, whichever is longer

12. A history within the past 1 year of drug or alcohol dependence or abuse.

13. Positive urine screen for drugs of abuse at Screening.(positive Cannabis/Cannabinol
results are acceptable if there is a documented history of stable use for medical
purposes).

14. Known allergy or hypersensitivity to alprazolam.

15. History of glaucoma.

16. Subjects who currently have an active major psychiatric disorder where changes in
pharmacotherapy are needed or anticipated during the study.

17. 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.

18. Significant hepatic, renal, gastroenterologic, cardiovascular (including ischemic
heart disease and congestive heart failure), endocrine, neurologic or hematologic
disease.

19. Subjects who, in the opinion of the Investigator, should not participate in the study
for any reason, including if there is a question about the stability or capability of
the subject to comply with the trial requirements.
We found this trial at
37
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550 East Van Buren Street
Phoenix, Arizona 85004
Principal Investigator: Steve Chung, MD
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524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Principal Investigator: Yanny Phillips, DO
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Principal Investigator: Thomas Wychowski, MD
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Bethesda, Maryland 20817
Principal Investigator: Pavel Klein, MD
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Boston, Massachusetts 02115
Principal Investigator: Jong Woo Lee, MD
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Brooklyn, New York 11203
Principal Investigator: Arthur Grant, MD
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Charlotte, North Carolina 28207
Principal Investigator: Rajdeep Singh, MD
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Rebecca O'Dwyer, MD
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Concord, North Carolina 28025
Principal Investigator: Michael Amiri, MD
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Dallas, Texas 75390
Principal Investigator: Hina Dave, MD
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Edison, New Jersey
Principal Investigator: Wei MA, MD, MS
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Honolulu, Hawaii 96817
Principal Investigator: Kore Liow, M.D.
Phone: 808-261-4476
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Houston, Texas 77030
Principal Investigator: Omotola Hope, MD
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4500 San Pablo Rd S
Jacksonville, Florida 32224
(904) 953-2000
Principal Investigator: William Tatum, MD
Mayo Clinic Florida Thousands of people come to Mayo Clinic in Jacksonville, Fla., annually for...
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Kingston 5,
Principal Investigator: Amza Ali, DM
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Las Vegas, Nevada 89106
Principal Investigator: Constance Brown, MD
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Little Rock, Arkansas 72205
Principal Investigator: Victor Biton, MD
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Lynchburg, Virginia 24502
Principal Investigator: Batool Kirmani, MD
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Miami, Florida 33175
Principal Investigator: Kim Cruz, MD
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New Haven, Connecticut 6520
(203) 432-4771
Principal Investigator: Adithya Sivaraju, MD
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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New Orleans, Louisiana 70121
Principal Investigator: Fawad Khan, MD
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New York, New York 10016
Principal Investigator: Blanca Vazquez, MD
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New York, New York 10021
Principal Investigator: Ruben Kuzniecky, MD
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New York, New York 10029
Principal Investigator: Ji Yeoun Yoo, MD
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5600 Oakbrook Parkway
Norcross, Georgia 30093
Principal Investigator: Daniel Tarquinio, MD
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Orlando, Florida 32806
Principal Investigator: Ahmed Sadek, MD
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Palo Alto, California 94304
Principal Investigator: Jessica Falco-Walter, MD
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Panama City, Florida 32405
Principal Investigator: George Barrio, MD
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Pasadena, California 91105
Principal Investigator: John De Beixedon, MD
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Michael Gelfand, MD, PhD
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Michael Sperling, MD
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Portland, Oregon 97239
Principal Investigator: David Spencer, MD
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Robert Hogan, MD
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Stockbridge, Georgia 30281
Principal Investigator: Phillip Nowlin, MD
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Tacoma, Washington 98405
Principal Investigator: Steven Phillips, MD
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Washington, District of Columbia 20037
Principal Investigator: Anumeha Sheth, MD, MD
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West Bloomfield, Michigan 48322
Principal Investigator: Steven Schechter, MD
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