EUCTR2011-004109-25-PLActive, not recruitingPhase 1
An Open-Label Safety Study of USL261 in the Outpatient Treatment of Subjects with Seizure Clusters
psher-Smith Laboratories, Inc.0 sites350 target enrollmentStarted: October 1, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 350
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Subject or 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 a competent, adult (age =18 years) caregiver(s) who is able to recognize and observe the subject's seizure cluster episodes,
- •who is 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 of the subject, or a person who provides daily care to the subject who has a significant personal relationship with the subject.
- •3. Subject is 12 years of age or older at Visit 1.
- •4. Subject has an established diagnosis of partial or generalized epilepsy.
- •5. Subject has a documented history of seizure clusters that includes all the following:
- •a. The subject's seizure cluster pattern is observable, stereotyped, and recognizably different from the subject's other non-cluster seizure
- •activity (if any) in seizure type, duration, severity, or frequency, and of the same type that was approved by the central reviewer in study P261-
- •b. A documented history of seizure clusters lasting a minimum of 10 minutes from the time the seizure cluster is recognized.
- •c. As part of the subject's stereotyped seizure cluster pattern, a second seizure typically occurs within 6 hours from the time of recognition of the seizure cluster.
- •d. The subject's stereotyped seizure cluster pattern is composed of multiple (=2) partial or generalized seizures.
- •e. The subject's stereotyped seizure cluster pattern was established > 3 months before Visit 1 of study P261-401.
- •f. A frequency of =3 stereotyped seizure clusters during the year before Visit 1 of study P261-401.
- •g. At least 1 stereotyped seizure cluster occurring at least once in the 4 months before Visit 1 of study P261-401.
- •6. Subject has successfully completed study P261-401 and the subject and caregiver have demonstrated adequate compliance with P261-401 study procedures as determined by the investigator, OR, if Study P261-
- •401 has been terminated, the subject completed the Test Dose Visit
- •(Visit 2) of study P261-401 and the subject did not meet any Visit 2
- •exclusion criteria in study P261-401.
- •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 as determined in study P261-401?
- •c. Is the subject a female who has written medical documentation of being permanently sterilized (e.g. hysterectomy, double oophorectomy,
- •bilateral salpingectomy)?
- •d. Has the subject agreed to use two effective methods of contraception during the entire study if she is sexually active or will become sexually active during the study (except where local law or regulation differs; approval by USL or designee is required in such cases)?
- •Examples of two effective methods of contraception include the following:
- •- A diaphragm and a condom with spermicide.
- •- An intrauterine device (IUD) used in combination with a barrier method (e.g. condom, diaphragm, or cervical cap with spermicide).
- •- Hormonal methods (e.g., high-dose birth control pills, Depo-Provera) or tubal ligation used in combination with a barrier method (e.g., condom, diaphragm, or cervical cap with spermicide).
- •Note that hormonal contraception alone is not considered adequate for thi
Exclusion Criteria
- •1. Subject experienced a seizure cluster progressing to status epilepticus during or since his/her perticipation in Study P261-401.
- •2. Subject has a positive pregnancy test at any visit or is pregnant, considering becoming pregnant, or is breastfeeding (female subjects only).
- •3. Subject who, in the opinion of the investigator, is experiencing an ongoing, uncontrolled, clinically significant adverse event(s) from P261-
- •401 at Visit 1 or did experience a clinically significant adverse event in study P261-401 that might prevent the subject from safely participating
- •in the study.
- •4. Subject has consumed any clinically significant CYP450 3A inhibitor/inducer, opioid, or other respiratory depressant, not including antiepileptic drugs (AEDs), within the required washout period before Visit 1
- •5. Subjects using chronic benzodiazepine(s); chronic use is defined as use for 4 or more days in a 7-day period on average.
- •6. Subject has a neurological disorder that is likely to progress in the next year.
- •7. Subject has a history of acute narrow-angle glaucoma.
- •8. Subject has a medical condition including uncontrolled cardiac, pulmonary, renal, hepatic, or gastrointestinal disease that could interfere with the study, subject safety/safety monitoring, or is not stable despite current therapy.
- •9. Subject has severe chronic cardio-respiratory disease with baseline room air oxygen saturations < 90%, New York Heart Association class
- •III or IV functional status, or the need for ambulatory oxygen.
- •10. Subject has had psychogenic, non-epileptic seizure(s) during or since the P261-401 study.
- •11. Subject has suicidality, defined as any of the following: a) active suicidal plan/intent or active suicidal thoughts during or since the P261-
- •401 study as defined by a Columbia-Suicide Severity Rating Scale (CSSRS) suicidal ideation score =3, b) any suicide attempt during or since
- •the P261-401 study as determined by the C-SSRS or medical history, or c) other clinically significant suicidality as determined by the
- •investigator.
- •12. Subject, in the investigator's opinion, has met the criteria for a major depressive episode during or since the P261-401 study (criteria defined
- •by the current edition of the Diagnostic and Statistical Manual of Mental Disorders).
- •13. Subject has or has had psychosis during or since the P261-401 study, excluding postictal psychosis
- •14. Subject has a history of drug or alcohol abuse during or since study P261-401.
Investigators
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