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CEP-37247

Phase 1

Sciatica | Small molecule | Pain |Teva Pharmaceutical Industries Limited|Last Updated: Jul 21, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment98

FDA Designations

No designations recorded

Clinical trial landscape

CEP-37247 · 1 trial · 1 indication

Phase 1 1
NCT01240876Study to Evaluate the Safety and Efficacy of Placulumab (CEP-37247) Administered by the Transforaminal Epidural Route for the Treatment of Patients With Lumbosacral Radicular Pain Associated With Disk HerniationSciatica
COMPLETED98 Analytics
PHASE1COMPLETED
Study to Evaluate the Safety and Efficacy of Placulumab (CEP-37247) Administered by the Transforaminal Epidural Route for the Treatment of Patients With Lumbosacral Radicular Pain Associated With Disk Herniation
SciaticaUnlock trial analytics

Study Endpoints

Primary Endpoints

Occurrence of adverse events compared to placebo
throughout the 28-week double-blind treatment period
Mean change in the weekly average of daily average pain intensity (API) in the affected leg on the 11-Point Numerical Rating Scale (NRS-11)
at week 4 compared with baseline

The average pain intensity over the past 24 hours on the NRS-11 will be collected daily by electronic diary.

Secondary Endpoints

Weekly average of daily leg API score as assessed by the NRS-11 from electronic diary entries
at each of the first 6 weeks
Weekly average of daily back API score as assessed by the NRS-11 from electronic diary entries
at each of the first 6 weeks
Weekly average of daily worst leg pain score as assessed by the NRS-11 from electronic diary entries
at each of the first 6 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CEP-37247EXPERIMENTAL -
Matching placeboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
CEP-37247DRUG0.5-, 1-, 3-, 6-, and 12-mg doses of CEP-37247 will be administered by the transforaminal epidural route.
PlaceboDRUGMatching placebo vials will be filled with the buffered solution for CEP-37247.
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: * Over the 4 days prior to the randomization visit, the patient has a mean score greater than or equal to 5 (of 10) for "Average Pain Over the Past 24 Hours" for the pain in the affected leg as assessed by the 11-Point Numerical Rating Scale (NRS-11) captured in the electronic d...

Countries:United StatesAustralia
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Frequently asked questions about CEP-37247

What is CEP-37247 used for?

CEP-37247 is an investigational small molecule being developed for the treatment of sciatica, specifically lumbosacral radicular pain associated with disk herniation. It is administered by the transforaminal epidural route. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes CEP-37247?

CEP-37247 is being developed by Teva Pharmaceutical Industries Limited, a company listed on the stock exchange under the ticker TEVA. The drug is an investigational small molecule intended for the treatment of sciatica and is currently in Phase 1 clinical trials.

What phase is CEP-37247 in?

CEP-37247 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial has been completed, and the drug is being studied for the treatment of sciatica, specifically lumbosacral radicular pain associated with disk herniation.

What clinical trials is CEP-37247 in?

CEP-37247 has one completed clinical trial, identified as NCT01240876. This Phase 1 study evaluated the safety and efficacy of CEP-37247, also known as placulumab, administered by the transforaminal epidural route in patients with lumbosacral radicular pain associated with disk herniation. The trial enrolled 98 participants in the United States and Australia.

Is CEP-37247 the same as placulumab?

Yes, CEP-37247 is also known as placulumab. In clinical trial NCT01240876, the study title refers to the drug as placulumab (CEP-37247), confirming that these names refer to the same investigational drug being developed for the treatment of sciatica.