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COMPLETED Phase 1

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

NCT01240876 · View on ClinicalTrials.gov ↗

Study Summary

The primary objective of the study is to evaluate the safety and efficacy of CEP-37247 compared with placebo as assessed by the occurrence of adverse events, and the mean change in average pain intensity (API) in the affected leg.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG CEP-37247

Study Locations (20)

California

  • Teva Investigational Site 22 — La Mesa
  • Teva Investigational Site 18 — Laguna Hills
  • Teva Investigational Site 19 — Pasadena
  • Teva Investigational Site 2 — Pasadena

South Carolina

  • Teva Investigational Site 1 — Greenville
  • Teva Investigational Site 11 — North Charleston
  • Teva Investigational Site 6 — Spartanburg

Florida

  • Teva Investigational Site 14 — Orlando
  • Teva Investigational Site 5 — Sarasota

Georgia

  • Teva Investigational Site 10 — Marietta
  • Teva Investigational Site 13 — Marietta

Utah

  • Teva Investigational Site 4 — Orem
  • Teva Investigational Site 3 — Salt Lake City

Illinois

  • Teva Investigational Site 9 — Bloomington

Kansas

  • Teva Investigational Site 15 — Overland Park

Louisiana

  • Teva Investigational Site 8 — Shreveport

Trial Details

FieldValue
Enrollment Target 98 participants
Start Date 2011-01
Est. Completion 2013-04
Phase Phase 1

Sponsor

Cephalon

17 total trials

Interested in This Trial?

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01240876

The ClinicalTrials.gov registry entry for NCT01240876 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cephalon, which has 17 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Sciatica appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01240876 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, South Carolina, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01240876 about?

NCT01240876 is a clinical study titled "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". The primary objective of the study is to evaluate the safety and efficacy of CEP-37247 compared with placebo as assessed by the occurrence of adverse events, and the mean change in average pain intensity (API) in the affected leg.

What is the current status of trial NCT01240876?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 98 participants. The study started on 2011-01. Estimated completion is 2013-04.

What conditions does trial NCT01240876 study?

This clinical trial studies the following conditions: Sciatica. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01240876?

The interventions under investigation include: Placebo (DRUG), CEP-37247 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01240876?

This trial is sponsored by Cephalon, which has 17 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01240876 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial