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Trial record 7 of 2651 for:    ( Map: Idaho, United States )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03613662
Recruitment Status : Completed
First Posted : August 3, 2018
Last Update Posted : March 20, 2019
Sponsor:
Collaborator:
Worldwide Clinical Trials
Information provided by (Responsible Party):
Scilex Pharmaceuticals, Inc. ( Semnur Pharmaceuticals, Inc. )

Brief 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.

Condition or disease Intervention/treatment Phase
Lumbosacral Radicular Pain Drug: SP-102 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Single-arm Study to Characterize the Pharmacodynamics and Safety of Repeat Dose SP-102 Administered by Epidural Injection in Subjects With Lumbosacral Radiculopathy
Actual Study Start Date : July 13, 2018
Actual Primary Completion Date : March 15, 2019
Actual Study Completion Date : March 15, 2019

Arm Intervention/treatment
Experimental: SP-102
SP-102
Drug: SP-102
Injection




Primary Outcome Measures :
  1. Change in plasma cortisol in mcg/dL [ Time Frame: Baseline, 12 Weeks ]
  2. Change of white blood cell counts in 10^3/mcL [ Time Frame: Baseline, 12 Weeks ]
  3. Change in blood glucose in mg/dL [ Time Frame: Baseline, 12 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Able and willing to read, write, and understand the English language and provide English language written informed consent prior to beginning any study procedures.
  • Age 18 to 70 years (inclusive) at the Screening Visit.
  • A diagnosis of lumbosacral radicular pain (sciatica).
  • Agrees to follow study-specific medication requirements.
  • If sexually active and a female of child-bearing potential or a male capable of bearing a child, agrees to use an effective method of birth control during the study.
  • Has reviewed all study specific materials and has, in the opinion of the Investigator, the abilities to understand and appropriately complete all study procedures.

Main Exclusion Criteria:

  • Has radiologic evidence of a condition that would compromise study outcomes.
  • Has ever had lumbosacral back surgery or plans to undergo spine surgical intervention while in the study.
  • Has been diagnosed with insulin dependent diabetes mellitus.
  • Presence of any other disorder, condition or circumstance (including secondary gain) that, in the opinion of the Investigator, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments.
  • Use of any investigational drug and/or device within 30 days, or is scheduled to receive an investigational drug other than blinded study drug during this study.
  • Has a body mass index ≥40 kg/m2.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03613662


Locations
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United States, Idaho
Semnur Research Site 1
Boise, Idaho, United States, 83713
Sponsors and Collaborators
Semnur Pharmaceuticals, Inc.
Worldwide Clinical Trials
Investigators
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Study Director: Dmitri Lissin, MD Semnur Pharmaceuticals, Inc.

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Responsible Party: Semnur Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03613662     History of Changes
Other Study ID Numbers: SP-102-03
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Scilex Pharmaceuticals, Inc. ( Semnur Pharmaceuticals, Inc. ):
lumbosacral radicular pain
sciatica
leg pain