Clinical Trial to evaluate the efficacy, safety and tolerability of Midazolam Intranasal Spray compared with a placebo administered through the nose (intranasal) for the treatment of intermittent bouts of increased seizure in a site that monitors epilepsy.

• Conditions: Epilepsy; MedDRA version: 17.1Level: LLTClassification code 10015052Term: Epileptic seizureSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-003961-49-BE
• Lead Sponsor: psher-Smith Laboratories, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-26
• Last Update Posted: 16 November 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

A subject will be eligible for enrollment in the study if all of the following criteria apply:
1.The subject or the subject’s legally acceptable representative (LAR) has provided written informed consent, and subject has provided written assent where required by local law or Institutional Review Board (IRB)/Independent Ethics Committee (IEC) policy
2.Subject has been admitted to the institution’s EMU for seizure characterization or pre-surgical evaluation, or such admission is planned within 28 days
3.Subject body weight is = 40 kg to = 125 kg (inclusive)
4.Subject is = 12 years of age at Screening
5.Subject has an established diagnosis of partial or generalized epilepsy
Are the trial subjects under 18? yes
Number of subjects for this age range: 18
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

1.Subject has a medical condition that could interfere with the absorption or pharmacokinetics of USL261
2.Subject has history of status epilepticus in the 6 months prior to screening
3.Subject 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 12 months
4.Subject has a positive alcohol test or a positive urine drug screen (UDS) not associated with documented legitimate medical use. Individuals with cognitive disability that precludes the collection of a urine sample by conventional means are exempt from the screening UDS requirement provided that the subject is deemed unlikely to have been recently exposed to drugs of abuse based on the opinion of the investigator and the reason the urine could not be obtained is documented
5.Subject has respiratory failure (or is at risk for respiratory failure) or other severe cardio-respiratory disease with New York Heart Association Class III or IV functional status, or requires supplemental oxygen
6.Subject has acute narrow-angle glaucoma
7.Subject (females only) has a positive pregnancy test during the Screening Phase or is currently pregnant or breastfeeding at time of Screening or time of admission to the EMU
8.Subject has a prior history of any significant adverse reactions (including rash) to benzodiazepines or known allergies to midazolam or formulation components
9.Subject requires concomitant treatment with any of the prohibited substances listed in this protocol (including strong CYP3A4 inhibitors or respiratory depressants), or cannot safely discontinue prohibited substances with sufficient washout prior to the Treatment Phase (See Appendix 1)
10.Subject is receiving chronic benzodiazepine treatment (defined as an average of = 4 administrations per week) and cannot safely withdraw from such treatment within the washout period prior to the Treatment Phase. The management of safe withdrawal of benzodiazepine therapy is left to the discretion of the investigator. Benzodiazepines that are used for rescue therapy of seizures or for non-epilepsy indications are allowed provided they are typically used = 3 times in a 7-day period
11.Subject has any clinically significant laboratory abnormality as determined by the investigator at Screening
12.Subject has any clinically significant 12-lead electrocardiogram (ECG) findings as determined by the investigator at Screening
13.Subject has any clinically significant abnormal vital sign values as determined by the investigator at Screening
14.Subject is currently using an investigational drug or device or has used such within the 60 days prior to the Screening Phase. The use of experimental non-interventional devices such as seizure detection devices is not considered exclusionary.
15.Subject has previously participated in a study of USL261
16.Subject has any condition that may interfere with subject safety/safety monitoring, or preclude the safe administration of a benzodiazepine, or is not appropriate for the study for any other reason as determined by the investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified