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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01529034
Registration number
NCT01529034
Ethics application status
Date submitted
3/02/2012
Date registered
8/02/2012
Date last updated
20/01/2023
Titles & IDs
Public title
Study to Evaluate the Long-term Safety and Tolerability of USL261 in Patients With Seizure Clusters
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Scientific title
An Open-Label Safety Study of USL261 in the Outpatient Treatment of Subjects With Seizure Clusters
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Secondary ID [1]
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2011-004109-25
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Secondary ID [2]
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P261-402
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Epilepsy
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Condition category
Condition code
Neurological
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Epilepsy
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - USL261
Experimental: USL261 - Intranasal midazolam 5 mg
Treatment: Drugs: USL261
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Duration of Safety Observation
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Assessment method [1]
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Duration of participant study participation for collection of long term safety data
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Timepoint [1]
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From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.
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Primary outcome [2]
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Participants Meeting Predefined Safety Criteria for Vital Signs
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Assessment method [2]
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Participants meeting predefined safety criteria for vital signs (systolic blood pressure [SBP] <85 mm Hg, SBP change from baseline >/= 40 mm Hg, diastolic BP [DBP] <50 mm Hg, DBP change from baseline >/=30 mm Hg, pulse rate <50 beats per minute (bpm), pulse rate >120 bpm, pulse rate change >/= 40 bpm at any visit post baseline or for caregiver recorded participant respiration rate [RR] <8 breaths per minute (brpm) or >24 brpm) after any USL261 treated seizure cluster episode. Abnormal vital signs were assessed separately by investigator and recorded as adverse events if applicable.
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Timepoint [2]
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From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.
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Primary outcome [3]
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Participants With Laboratory Abnormalities Meeting Predefined Criteria
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Assessment method [3]
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Participants with abnormal laboratory finding, at any time post baseline, meeting predefined criteria. Abnormal laboratory findings were assessed separately by investigator and recorded as adverse events if applicable. Alanine aminotransferase (ALT); Alkaline phosphatase (ALP); Aspartate aminotransferase (AST); Gamma glutamyl transferase (GGT); upper limit of normal (ULN)
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Timepoint [3]
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From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.
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Primary outcome [4]
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Participants With Clinically Significant Abnormalities Physical Examination
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Assessment method [4]
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Participants with abnormal findings, at any time post baseline, on physical examination considered clinically significant by the investigator.
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Timepoint [4]
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From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.
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Primary outcome [5]
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Participants With Clinically Significant Abnormalities on Neurologic Examination
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Assessment method [5]
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Participants with abnormal findings, at any time post baseline, on neurologic examination considered clinically significant by the investigator
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Timepoint [5]
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From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.
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Primary outcome [6]
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Participants With Clinically Significant Abnormalities on Nasal Examination
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Assessment method [6]
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Participants with abnormal findings, at any time post baseline, on nasal examination considered clinically significant by the investigator
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Timepoint [6]
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From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.
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Primary outcome [7]
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Participant Change in B-SIT Score
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Assessment method [7]
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Change in participant Brief Smell Identification Test (B-SIT) score from baseline to last visit with assessment. The B-SIT is a self-administered 12-item test; the score indicates odors correctly identified (0 to 12). The B-SIT was added while the study was already ongoing (Protocol Amendment 4, 20 May 2015) in response to a regulatory request. The test was only implemented at sites in the United States and included only participants considered by the investigator to have adequate cognitive ability to perform the test. Baseline was defined as the latest non-missing value prior to administration of USL261 in the Test Dose Phase of Study P261-401.
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Timepoint [7]
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From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.
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Primary outcome [8]
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Participants With Suicidal Ideation
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Assessment method [8]
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Participants with suicidal ideation reported on Columbia-Suicide Severity Rating Scale (C-SSRS) questionnaire at any post-baseline visit. Responses including: Wish to be Dead; Non-Specific Active Suicidal Thoughts; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent; and Any Suicidal Ideation Regardless of Type.
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Timepoint [8]
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From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.
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Primary outcome [9]
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Emergency Room/Emergency Medical Service Visits
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Assessment method [9]
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Participants requiring emergency room (ER)/emergency medical service (EMS) visit within 24 hours after any USL261 treated seizure cluster (including for continued seizures)
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Timepoint [9]
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From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.
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Secondary outcome [1]
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Number of Treated Seizure Clusters Meeting Criteria for Treatment Success
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Assessment method [1]
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Number of Treated Seizure Clusters Meeting Criteria for Treatment Success: Termination of seizure(s) within 10 minutes and no recurrence within 6 hours after administration of first dose of USL261 (intranasal midazolam 5 mg)
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Timepoint [1]
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6 hours after first dose of USL261 for each treated seizure cluster
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Eligibility
Key inclusion criteria
- Has a competent, adult caregiver who can recognize and observe the subject's seizure
cluster episodes
- 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
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Has experienced status epilepticus during or since the P261-401 study
- 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
- Has a neurological disorder that is likely to progress in the next year
- Has a history of acute narrow-angle glaucoma
- 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
- Subject has severe chronic cardio-respiratory disease or the need for ambulatory
oxygen
- Has had psychogenic, non-epileptic seizure(s) during or since the P261-401 study
- Has active suicidal plan or intent as determined by the C-SSRS at Visit 1 or medical
history
- Subject has had vagus nerve stimulator (VNS) implanted since the completion of study
P261-401
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
175
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Australia, New South Wales - Randwick
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Recruitment hospital [2]
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Australia, Victoria - Heidelberg west
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Recruitment hospital [3]
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Australia, Victoria - Parkville
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Recruitment postcode(s) [1]
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- Randwick
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Recruitment postcode(s) [2]
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- Heidelberg west
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Recruitment postcode(s) [3]
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- Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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United States of America
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State/province [2]
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Arkansas
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United States of America
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State/province [3]
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California
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Country [4]
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United States of America
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State/province [4]
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Colorado
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United States of America
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Connecticut
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Country [6]
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United States of America
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State/province [6]
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Florida
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Country [7]
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United States of America
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Idaho
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Country [8]
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United States of America
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Illinois
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Country [9]
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United States of America
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State/province [9]
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Kentucky
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Country [10]
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United States of America
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State/province [10]
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Maryland
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Country [11]
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United States of America
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Michigan
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Country [12]
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United States of America
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Minnesota
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United States of America
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Missouri
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Country [14]
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United States of America
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New Hampshire
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Country [15]
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United States of America
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State/province [15]
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New Jersey
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United States of America
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New York
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North Carolina
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Oklahoma
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Pennsylvania
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Country [20]
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United States of America
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Tennessee
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Country [21]
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United States of America
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State/province [21]
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Texas
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Country [22]
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Canada
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Ontario
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Country [23]
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Canada
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State/province [23]
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Quebec
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Country [24]
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Germany
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Bayern
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Germany
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Hessen
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Germany
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Nordrhein-Westfalen
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Country [27]
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Germany
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State/province [27]
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Westfalen-Lippe
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Hungary
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Budapest
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Israel
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Haifa
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Israel
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State/province [30]
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Petah Tikvah
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Israel
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Ramat Gan
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Country [32]
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New Zealand
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Canterbury
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Poland
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Gdansk
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Poland
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Katowice
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Poland
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Lublin
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Spain
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Andalucia
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Spain
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Cataluyna
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Spain
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Madrid
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kharkiv
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Ukraine
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Odessa
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Ukraine
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Poltava
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Ukraine
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State/province [43]
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Ternopil
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Country [44]
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Ukraine
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State/province [44]
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Vinnytsa
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
UCB Biopharma S.P.R.L.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to examine the long-term safety and tolerability of USL261 in
the treatment of seizure clusters.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01529034
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Phone
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Contact person for public queries
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01529034
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