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Topiramate liquid formulation;Topiramate Sprinkle formulation

Phase 1

Epilepsy | Small molecule | Neurology |Johnson & Johnson|Trials Updated: Jun 8, 2011

Topiramate liquid formulation;Topiramate Sprinkle formulation target and mechanism

Molecular targetGRIA4, GRIA3, GRIA2, GRIA1, GRIK1, GRIK5
Target classAntagonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Topiramate liquid formulation;Topiramate Sprinkle formulation clinical trials

Topiramate liquid formulation;Topiramate Sprinkle formulation · 1 trial · 1 indication

Phase 1 1
NCT00701493A Phase 1 Bioavailability Study of Topiramate Oral Liquid Formulation Compared to the Marketed Sprinkle Capsule Formulation in Healthy AdultsEpilepsy
COMPLETED40 Analytics
PHASE1COMPLETED
A Phase 1 Bioavailability Study of Topiramate Oral Liquid Formulation Compared to the Marketed Sprinkle Capsule Formulation in Healthy Adults
EpilepsyUnlock trial analytics

Study Endpoints

Primary Endpoints

AUClast, AUC¥, and Cmax (Area Under the Curve (last), Area Under the Curve (infinity) and maximum plasma concentration); Incidence, severity, and type of adverse event changes in laboratory results, physical exam, ECG, vital signs.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Interventions

NameTypeDescription
Topiramate oral liquid formulation;Topiramate Sprinkle formulationDRUG -
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Body mass index (BMI) between 19 and 32 kg/m2, inclusive * Women of non-child-bearing potential or practicing birth control * Have a normal electrocardiogram (ECG) * Be in good health, in the opinion of the investigator * Be sufficiently alert to understand and communicate int...

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Frequently asked questions about Topiramate liquid formulation;Topiramate Sprinkle formulation

What is topiramate oral liquid formulation?

Topiramate oral liquid formulation is an investigational liquid dosage form of topiramate, a small molecule being developed by Johnson & Johnson (JNJ) for epilepsy. It is designed as an alternative to the marketed topiramate sprinkle capsule formulation. The program is in Phase 1 clinical development.

What is topiramate oral liquid formulation used for?

Topiramate oral liquid formulation is being developed for epilepsy. It is intended to provide a liquid dosing option for patients who may have difficulty swallowing capsules. The formulation is investigational and has been studied in healthy adult volunteers rather than in patients with epilepsy.

What does topiramate oral liquid formulation target?

Topiramate oral liquid formulation targets AMPA and kainate glutamate receptors, specifically GRIA1, GRIA2, GRIA3, GRIA4, GRIK1, and GRIK5. It acts as an antagonist at these receptors. This mechanism is consistent with the pharmacological profile of topiramate, a small molecule used in epilepsy.

Who makes topiramate oral liquid formulation?

Johnson & Johnson, ticker JNJ, is the developer of topiramate oral liquid formulation. The company is responsible for the clinical development of this investigational liquid dosage form of topiramate.

What phase is topiramate oral liquid formulation in?

Topiramate oral liquid formulation is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The Phase 1 program has been completed, with no active trials currently listed.

What clinical trials is topiramate oral liquid formulation in?

Topiramate oral liquid formulation has been studied in one completed Phase 1 trial, NCT00701493. This bioavailability study compared the oral liquid formulation to the marketed sprinkle capsule formulation in 40 healthy adults. The trial was randomized, uncontrolled, and not double-blind.

Is topiramate oral liquid formulation the same as topiramate sprinkle formulation?

No, topiramate oral liquid formulation and topiramate sprinkle formulation are different dosage forms. The liquid formulation is an investigational oral liquid, while the sprinkle formulation is a marketed capsule that can be sprinkled on food. Both contain topiramate and are developed by Johnson & Johnson.