An Open-Label Safety Study of USL261 (Intranasal Midazolam) in the Outpatient Treatment of Subjects with Cluster Seizures

Study ID
STU 112011-079

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Lauren Smith
214-456-0057
laurenc.smith@utsouthwestern.edu

Principal Investigator
Paul Van Ness

Summary

This open-Label study consist of 6 visits over a 12 month period of time to evaluate the long-term safety and tolerability of uSL261 (intranasal Midazolam) for the treatment of cluster seizures. The subject must have a caregiver (required) to meet the recorded endpoints of home evaluation of the subject after a cluster of seizure and the administeration of the study drug.

Participant Eligibility

Inclusion
1. Subject or subject[Single Quote]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/Independent Ethics Committee policy
2. Subject has a competent, adult (age >= 18) caregiver(s) who is able to recognize and observe the
subject[Single Quote]s seizure cluster episodes, willing to be trained in the study procedures, and has provided
written informed consent; the caregiver(s) must be a relative, partner, friend or LAR who has a
significant personal relationship with the subject
3. Subject is between 14 and 66 years of age, inclusive at Visit 1. At the UT Southwestern Site, only subjects aged 18 years up to 66 years of age, will be enrolled at the UT Southwestern Aston Neurology Clinic as this clinic serves the adult population.
4. Subject has an established diagnosis of partial onset seizures.
5. Subject has adocumented history od seizure clusters, with a pattern that is observable, stereotyped, and recognizabily different from the subject's other non-cluster seizure activity; subject's seizure cluster must:
a. be of the same type that was approved by the central reciewer in study P261-401.
b. last at least 10 minutes after recognized as a seizure cluster
c. last no more than 6 hours.
d. be composed of multiple (>= 2) partial or generalized seizures.
e. be established > 3 months before visit 1 of study P261-401.
f. have occurred >= 4 times in the year before visit 1 of study P261-401.
g. have occurred at least once in the 3 months before Viait 1 of the study P261-401
6.Subject has successfully completed sudy P261-401 and the subject and caregiver have demonstrated adequate compliance with P261-401 study procedures as determined by the investigator.
7. Subject is not likely to conceive, as indicated by a
* yes
* answer to at least 1 of the following
questions:
a. Is the subject a male?
b. Is the subject a postmenopausal female with greater than 2 years since last menses and a
follicular stimulating hormone value greater than 40 mIU/mL?
c. Has the subject agreed to use an acceptable, double method of contraception during the entire
study (Except where local law or regulation differs; approval by USL or designee is required in such cases)?
Examples of acceptable methods of contraception include:

* A diaphragm with a condom,

* An intrauterine device (IUD) with spermicide,

* Hormonal methods (eg, high-dose birth control pills, Depo-Provera), an IUD or
surgical sterilization (tubal ligation, etc.) used in combination with a barrier method
(condom, diaphragm, or cervical cap).
Note that hormonal contraception alone is not considered adequate for this study and must be
used in combination with another method. The type of birth control used must be approved by
the investigator or designee.
8. Subject's weight is 50 kg. to 125 kg., inclusive, at Visit 1.