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Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults (RePRIEVE-CM)

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ClinicalTrials.gov Identifier: NCT03727100
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : December 4, 2018
Sponsor:
Collaborator:
Lotus Clinical Research, LLC
Information provided by (Responsible Party):
Sollis Therapeutics, Inc.

Brief Summary:
This study will evaluate the safety and effectiveness of a new pain medication in development, clonidine micropellet. Participants will receive a single injection of either clonidine micropellet or sham injection for the treatment of low back and leg pain from sciatica.

Condition or disease Intervention/treatment Phase
Lumbosacral Radiculopathy Combination Product: Clonidine Micropellets Other: Sham Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Clonidine Micropellet vs Sham-Control
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Double-Blinded
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Randomized, Double-Blinded, Sham-Control Study to Evaluate the Efficacy and Safety of Clonidine Micropellets for the Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults
Actual Study Start Date : October 16, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Clonidine Micropellets
single dose injection into the lumbar epidural space
Combination Product: Clonidine Micropellets
Injection

Sham Comparator: Sham Control
non-epidural needle placement
Other: Sham
Injection




Primary Outcome Measures :
  1. Pain Intensity Difference (PID) for the average pain Numeric Rating Scale (NRS) from baseline to D30 in radicular leg pain [ Time Frame: Baseline to day 30 ]
    Difference in average pain score, using a scale of 0-10 with 0 no pain and 10 worst possible pain, from baseline to day 30.


Secondary Outcome Measures :
  1. Change in Oswestry Disability Index (ODI) score [ Time Frame: Baseline to day 30 ]
    6 categories of 10 question, each question is scored from 0-5 (minimum to maximum). The scores range from 0-100% with lower scores meaning less disability.

  2. Change in Numeric Rating Scale (NRS) leg pain 24 hrs post injection. [ Time Frame: 1 day post injection ]
    Difference in average pain score, using a scale of 0-10 with 0 no pain and 10 worst possible pain, from injection to 24 hrs post injection.

  3. Difference in Rescue medication consumption [ Time Frame: Baseline to day 30 ]
    Consumption from baseline through day 30

  4. Percent of subjects with significant improvement in pain [ Time Frame: Baseline to day 30 ]
    50 percent improvement in pain from baseline to day 30



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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:

  1. Be between 18 and 70 years of age (inclusive) at time the Informed Consent Form (ICF) is signed.
  2. Diagnosis of unilateral radicular leg pain.
  3. Women of childbearing potential must have a negative pregnancy test at Screening and within 24 hours prior to procedure and commit to adequate birth control during the the study.
  4. Understands the purpose and any risks associated with the procedure required for the study and is willing to participate in the study.
  5. Agrees to follow study-specific medication requirements.
  6. Be able to read, write, understand, and complete study-related tasks, and adequately communicate in English.

Main Exclusion Criteria:

  1. Medical condition or radiographic evidence that, in the Investigator's opinion, could adversely impact study outcomes.
  2. Received an lumbar epidural steroid injection, nerve block or similar procedure during the 4 weeks prior to Screening.
  3. Female subjects who are pregnant or breastfeeding.
  4. History of lumbar surgery.

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): NCT03727100


Contacts
Contact: Clinical Research Lead 859-552-5973 kay@sollistx.com

Locations
United States, California
Sollis Clinical Study Site 28 Recruiting
Santa Rosa, California, United States, 95401
Contact: Leny Engman       leny.engman@summitpainalliance.com   
Principal Investigator: Michael Yang, MD         
United States, District of Columbia
Sollis Clinical Study Site 30 Recruiting
Washington, District of Columbia, United States, 22205
Contact: Sidrah Sheikh       ssheikh@isppcenter.com   
Principal Investigator: Mehul Desai, MD         
United States, Illinois
Sollis Clinical Study Site 12 Recruiting
Bloomington, Illinois, United States, 61704
Contact: Katie Mahnke, CRC       kmahnke@milleniumpaincenter.com   
Principal Investigator: Ramsin Benyamin, MD         
Sollis Clinical Study Site 13 Recruiting
Chicago, Illinois, United States, 60657
Contact: Ivana Knezevic       drivanaknezevic@gmail.com   
Principal Investigator: Kenneth Candido, MD         
United States, Kentucky
Sollis Clinical Study Site 10 Recruiting
Edgewood, Kentucky, United States, 41017
Contact: Holly Dickens       hollydickens@otrimed.com   
Principal Investigator: Pragya Gupta, MD         
United States, New Jersey
Sollis Clinical Study Site 17 Active, not recruiting
Shrewsbury, New Jersey, United States, 60657
United States, Oklahoma
Sollis Clinical Study Site 19 Recruiting
Edmond, Oklahoma, United States, 73013
Contact: Jennifer Witherby, RN BSN COO       jw@clinrad.org   
Principal Investigator: Douglas Beall, MD         
United States, Texas
Sollis Clinical Study Site 22 Not yet recruiting
San Antonio, Texas, United States, 78229
Contact: Lisa Rodriguez       lisa@endeavorct.com   
Principal Investigator: Richard Pollak, MD         
Sollis Clinical Study Site 20 Recruiting
Tyler, Texas, United States, 75701
Contact: Jeanetta Patterson, RN BA       jeanettap@psctyler.com   
Principal Investigator: Aaron Calodney, MD         
United States, West Virginia
Sollis Clinical Study Site 23 Recruiting
Morgantown, West Virginia, United States, 26505
Contact: Anne Bolyard, EdD CRA CPRA       aebolyard@hsd.wvu.edu   
Principal Investigator: Richard M Vaglienti, MD         
Sponsors and Collaborators
Sollis Therapeutics, Inc.
Lotus Clinical Research, LLC
Investigators
Principal Investigator: Christopher Gilligan, MD Brigham and Women's Hospital

Responsible Party: Sollis Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03727100     History of Changes
Other Study ID Numbers: STX-015-18-01
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Clonidine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action