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TPM

Phase 1

Epilepsy | Small molecule | Neurology |Supernus Pharmaceuticals, Inc.|Trials Updated: Jun 2, 2016

TPM target and mechanism

ModalitySmall molecule

Also known as TPM XR

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

TPM clinical trials

TPM · 1 trial · 1 indication

Phase 1 1
NCT01284530Evaluation of the Pharmacokinetics, Safety, and Tolerability of TPM XR as Adjunctive Therapy in Pediatric Subjects With EpilepsyEpilepsy
COMPLETED30 Analytics
PHASE1COMPLETED
Evaluation of the Pharmacokinetics, Safety, and Tolerability of TPM XR as Adjunctive Therapy in Pediatric Subjects With Epilepsy
EpilepsyUnlock trial analytics

Study Endpoints

Primary Endpoints

steady-state pharmacokinetics (PK) of TPM XR and to assess the safety and tolerability
14 days

Relating to repeated oral dosing

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Conversion-25EXPERIMENTAL25 mg
Conversion-50EXPERIMENTAL50 mg
Conversion-100EXPERIMENTAL100 mg
Conversion-200EXPERIMENTAL200 mg

Interventions

NameTypeDescription
TPM XRDRUGEquivalent TDD in XR form, QD, Day 1-14
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Eligibility Criteria

Age Range4 Years to 17 Years
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: 1. Able to provide written IAF, as appropriate, with written informed permission (including ICF where required by regional laws or regulations) from the parent or LAR. 2. Male or female aged 4 to 17 years, inclusive, with a current diagnosis of partial onset or primary generaliz...

Countries:United States
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Frequently asked questions about TPM

What is TPM used for?

TPM is being studied as an adjunctive therapy for epilepsy, meaning it is added to existing seizure treatment rather than used alone. The clinical work on record is in pediatric patients with epilepsy, ages 4 years and older, in the United States. It is an investigational small molecule and is not established as an approved treatment.

Who is developing TPM?

TPM is being developed by Supernus Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker SUPN. The company is the sponsor behind the clinical program evaluating TPM XR as adjunctive therapy in pediatric epilepsy.

What phase is TPM in?

TPM is in Phase 1 clinical development. Its single recorded trial is a Phase 1 study, and no later-phase trials are on record. Because the program remains at this early stage, TPM is investigational and has not been shown to be approved for any indication.

What clinical trials is TPM in?

TPM has been studied in one clinical trial, NCT01284530, titled Evaluation of the Pharmacokinetics, Safety, and Tolerability of TPM XR as Adjunctive Therapy in Pediatric Subjects With Epilepsy. That Phase 1 trial enrolled 30 participants in the United States, used a controlled and randomized design, and is now completed.

Is TPM the same as TPM XR?

Yes, TPM XR is an alternative name for TPM. The two names refer to the same Supernus Pharmaceuticals asset, and the completed Phase 1 pediatric epilepsy trial is listed under the TPM XR name. Readers searching either term are looking at the same investigational program.

What is TPM XR used for in epilepsy?

TPM XR is being evaluated as adjunctive therapy in pediatric patients with epilepsy, added alongside their existing antiseizure treatment. The completed Phase 1 trial assessed pharmacokinetics, safety, and tolerability in 30 participants aged 4 years and older. It is an investigational small molecule and is not an established epilepsy treatment.