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Topiramate; flunarizine

Phase 1

Migraine | Small molecule | Neurology |Johnson & Johnson|Trials Updated: May 18, 2011

Topiramate; flunarizine development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Sep 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment75

FDA Designations

No designations recorded

Topiramate; flunarizine clinical trials

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
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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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Competitive Landscape -Migraine 43 trials

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Frequently asked questions about Topiramate; flunarizine

What is topiramate; flunarizine?

Topiramate; flunarizine refers to a combination of two small molecule drugs studied together for migraine. Johnson & Johnson (ticker JNJ) ran a Phase 1 drug interaction study of topiramate and flunarizine given together or separately. The combination is investigational and is not an approved product.

What is topiramate; flunarizine used for in migraine?

Topiramate; flunarizine was studied for migraine in a Phase 1 pharmacokinetic drug interaction trial. The trial enrolled 75 participants, including healthy volunteers and people with migraine, to evaluate how the two drugs affect each other when given together or separately. It is not an approved migraine treatment.

Who makes topiramate; flunarizine?

Johnson & Johnson, which trades under the ticker JNJ, is the developer associated with the topiramate; flunarizine combination. The company sponsored the Phase 1 drug interaction study of the two agents in migraine.

What phase is topiramate; flunarizine in?

Topiramate; flunarizine is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are ongoing. The combination is investigational and has not been approved for any indication.

What clinical trials is topiramate; flunarizine in?

Topiramate; flunarizine has been evaluated in one completed Phase 1 trial, NCT00752466, titled A Drug Interaction Study of the Pharmacokinetics of Topiramate and FLUNARIZINE When Given Together or Separately. The trial enrolled 75 participants aged 18 years and older, including healthy volunteers, and used a randomized, uncontrolled design.