A Conversion Study of Immediate Release (IR) and Modified Release (MR) Forms of Topiramate (TPM)
NCT01114854 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 69
Last updated 2017-05-18
Summary
This multi-center, two-treatment study compares the pharmacokinetic profiles of Immediate Release (IR) and Modified Release (MR) formulations of Topiramate (TPM) in patients with epilepsy.
Conditions
Interventions
- DRUG
-
Topiramate IR
- DRUG
-
Topiramate ER
Sponsors & Collaborators
-
Supernus Pharmaceuticals, Inc.
lead INDUSTRY
Principal Investigators
-
Paolo Baroldi, MD, PhD · Supernus Pharmaceuticals, Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-06-30
- Primary Completion
- 2010-12-31
- Completion
- 2011-01-31
Countries
- United States
Study Locations
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