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Topiramate; flunarizine

Phase 1

Human Volunteers | Small molecule | Neurology |Johnson & Johnson|Last Updated: May 18, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment75

FDA Designations

No designations recorded

Clinical trial landscape

Topiramate; flunarizine · 1 trial · 2 indications

Phase 1 1
NCT00752466A Drug Interaction Study of the Pharmacokinetics of Topiramate and FLUNARIZINE When Given Together or SeparatelyHuman Volunteers
COMPLETED75 Analytics
PHASE1COMPLETED
A Drug Interaction Study of the Pharmacokinetics of Topiramate and FLUNARIZINE When Given Together or Separately
Human Volunteers
NCT0075246675
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Study Endpoints

Primary Endpoints

For each treatment and each group, the plasma concentration at each time point and the pharmacokinetic parameters of interest will be summarized using descriptive summary statistics.

Secondary Endpoints

Incidence and severity of treatment-emergent adverse events and abnormal findings of other safety evaluations. Changes in clinical laboratory test and vital sign results from Baseline to End of Study or early termination will be evaluated.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Topiramate; flunarizineDRUG -
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Subjects in Group 1 must be diagnosed with migraine for at least 1 year prior to study start. Subjects must also have received any dose of flunarizine for the prophylaxis of migraine, for a minimum of 4 weeks prior to the run-in phase. Subjects in Group 2 must be healthy subje...

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