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Clonazepam

Phase 2

Epilepsy | Small molecule | Neurology |Jazz Pharmaceuticals plc|Last Updated: Jul 1, 2014

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

Clonazepam · 1 trial · 1 indication

Phase 2 1
NCT00594945Study of Intranasal Clonazepam in Adult Subjects With Epileptic SeizuresEpilepsy
COMPLETED45 Analytics
PHASE2COMPLETED
Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures
EpilepsyUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Spikes and Sharp Waves, Relative Change From Baseline to Treatment Day (%).
Change from baseline to treatment day

Summary of video EEG number of spikes and sharp waves. Over a 24 hour period.

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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Intranasal Clonazepam 2 mgEXPERIMENTAL -
Intranasal Clonazepam 3 mgEXPERIMENTAL -
Intranasal Clonazepam both Dose Groups 2 mg & 3 mgEXPERIMENTAL -

Interventions

NameTypeDescription
ClonazepamDRUG1 Dose
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites6

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

Countries:United StatesFinland
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