Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures

Jazz Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Epilepsy

Treatments: Drug: Clonazepam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00594945

07-001

Details and patient eligibility

About

Evaluate the safety and efficacy of intranasal Clonazepam in subjects with epilepsy.

Enrollment: 45 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Intranasal Clonazepam 2 mg

Experimental group

Treatment:

Drug: Clonazepam

Intranasal Clonazepam 3 mg

Experimental group

Treatment:

Drug: Clonazepam

Intranasal Clonazepam both Dose Groups 2 mg & 3 mg

Experimental group

Treatment:

Drug: Clonazepam