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Keppra

Phase 1

Seizure | Small molecule | Neurology |Novartis AG|Trials Updated: Mar 28, 2017

Keppra development status

Highest phase Phase 1
Registered trials 4 across 1 sponsor since Feb 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Keppra clinical trials

Keppra · 1 trial · 1 indication

Phase 1 1
NCT00946751To Demonstrate the Relative Bioavailability of Sandoz Inc. and UCB Pharma, Inc (Keppra) 750 mg Levetiracetam Tablets In Healthy Adults Volunteers Under Fasting ConditionsSeizure
COMPLETED20 Analytics
PHASE1COMPLETED
To Demonstrate the Relative Bioavailability of Sandoz Inc. and UCB Pharma, Inc (Keppra) 750 mg Levetiracetam Tablets In Healthy Adults Volunteers Under Fasting Conditions
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Study Endpoints

Primary Endpoints

Bioequivalence based on AUC and Cmax
10 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALLevetiracetam Tablets, 750 mg (Sandoz Inc.)
2ACTIVE_COMPARATORKeppra (Levetiracetam) Tablets, 750 mg (UCB Pharma, Inc)

Interventions

NameTypeDescription
Levetiracetam Tablets, 750 mg (Sandoz Inc.)DRUG -
Keppra (Levetiracetam) Tablets, 750 mg (UCB Pharma, Inc)DRUG -
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: * Positive test results for HIV or hepatitis B or C. * Treatment for drug or alcohol dependence.

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Frequently asked questions about Keppra

What is Keppra used for?

Keppra is a levetiracetam tablet formulation studied for seizure. The clinical trial referenced in this record enrolled healthy adult volunteers rather than patients with active seizure disorders, and it evaluated the 750 mg tablet under fasting conditions. Keppra is a small molecule in the neurology therapeutic area.

Who makes Keppra?

Keppra is associated with Novartis AG, which trades under the ticker NVS. The 750 mg levetiracetam tablet referenced in this record is also identified with UCB Pharma, Inc, and the bioavailability trial compared the Sandoz Inc. and UCB Pharma, Inc (Keppra) 750 mg levetiracetam tablets.

What phase is Keppra in?

Keppra is recorded at Phase 1 in this dataset. The single listed trial, NCT00946751, is a Phase 1 study that has been completed, with no active trials currently listed. The study was randomized and used an active control design.

What clinical trials is Keppra in?

Keppra is referenced in one clinical trial, NCT00946751, titled to demonstrate the relative bioavailability of Sandoz Inc. and UCB Pharma, Inc (Keppra) 750 mg levetiracetam tablets in healthy adult volunteers under fasting conditions. The trial is Phase 1, completed, randomized, active controlled, and enrolled 20 participants aged 18 years and older.

Is Keppra the same as levetiracetam?

Yes, Keppra is a brand name for levetiracetam. The record identifies the asset as Keppra (Levetiracetam) Tablets, 750 mg, from UCB Pharma, Inc. The trial title also refers to the product as 750 mg levetiracetam tablets, confirming that Keppra and levetiracetam refer to the same tablet formulation.