A Research Study to Characterize the Pharmacodynamics and Safety of Repeat Dose SP-102

NCT03613662 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2022-01-13

Study results available
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Summary

This is an open-label, single-arm, repeat dose study to characterize the pharmacodynamics and safety/tolerability of SP-102 administered by epidural injection.

Conditions

  • Lumbosacral Radicular Pain

Interventions

DRUG

SP-102

Injection

Sponsors & Collaborators

  • Worldwide Clinical Trials

    collaborator OTHER
  • Scilex Pharmaceuticals, Inc.

    collaborator INDUSTRY
  • Semnur Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Dmitri Lissin, MD · Scilex Pharmaceuticals, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-13
Primary Completion
2019-03-15
Completion
2019-03-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03613662 on ClinicalTrials.gov