Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures
Information source: Jazz Pharmaceuticals
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy
Intervention: Clonazepam (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Jazz Pharmaceuticals
Summary
Evaluate the safety and efficacy of intranasal Clonazepam in subjects with epilepsy.
Clinical Details
Official title: A Phase 2a, Open-Label,Proof -of-Concept Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures
Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment
Primary outcome: EEG
Secondary outcome: Safety
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of refractory epilepsy
- No Nasal conditions that would preclude the use of intranasal product
Exclusion Criteria:
- Subject with a clinical significant unstable medical abnormality
- Subject currently or regularly taking Clonazepam
Locations and Contacts
Tampere University Hospital, Tampere 33521, Finland; Recruiting
Mervi Mattila, Phone: 358 40 586 8471
Jukka Petola, MD, Principal Investigator
Mid-Atlantic Epilepsy & Sleep Center, Bethesda, Maryland 20817, United States; Recruiting
Arkady Barber, RN, Phone: 301-530-9744
Pavel Klein, M.B., Principal Investigator
Columbia Comprehensive Epilepsy Center, Neurological Institute, New York, New York 10032, United States; Recruiting
Alison Randall, Phone: 212-305-1684
Lawrence Hirsch, MD, Principal Investigator
Ohio State University, Columbus, Ohio 43210, United States; Recruiting
Janet Renner, Phone: 614-292-1043
Bassel Shneker, MD, Principal Investigator
Additional Information
Starting date: December 2007
Last updated: September 16, 2008
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