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Topiramate IR

Phase 1

Epilepsy | Small molecule | Neurology |Supernus Pharmaceuticals, Inc.|Last Updated: May 18, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment69

FDA Designations

No designations recorded

Clinical trial landscape

Topiramate IR · 1 trial · 1 indication

Phase 1 1
NCT01114854A Conversion Study of Immediate Release (IR) and Modified Release (MR) Forms of Topiramate (TPM)Epilepsy
COMPLETED69 Analytics
PHASE1COMPLETED
A Conversion Study of Immediate Release (IR) and Modified Release (MR) Forms of Topiramate (TPM)
EpilepsyUnlock trial analytics

Study Endpoints

Primary Endpoints

relative bioavailability at steady-state of TPM MR and TPM IR, as determined by TPM levels in plasma
2 weeks

Secondary Endpoints

relative bioavailability of TPM MR immediately following switch from TPM IR, as determined by TPM levels in plasma
2 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Topiramate IR followed by Topiramate EROTHERDosing with IR followed by dosing with ER

Interventions

NameTypeDescription
Topiramate IRDRUG -
Topiramate ERDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: 1. Adult male or female patients with epilepsy on stable doses of topiramate. 2. Able to voluntarily provide written informed consent to participate in the study. 3. Use of an effective form of birth control if of child-bearing potential. Exclusion Criteria: 1. Diagnosis of st...

Countries:United States
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