Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 70
Updated:3/21/2019
Start Date:October 16, 2018
End Date:August 1, 2019
Contact:Clinical Research Lead
Email:kay@sollistx.com
Phone:859-552-5973

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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

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.


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.
We found this trial at
25
sites
Morgantown, West Virginia 26505
Principal Investigator: Richard M Vaglienti, MD
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Morgantown, WV
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Albany, New York 12208
Principal Investigator: Charles Argoff, MD
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from
Albany, NY
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Bloomington, Illinois 61704
Principal Investigator: Ramsin Benyamin, MD
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from
Bloomington, IL
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Boston, Massachusetts 02115
Principal Investigator: Robert J Yong, MD
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from
Boston, MA
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Brookline, Massachusetts 02445
Principal Investigator: Jatinder Gill, MD
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from
Brookline, MA
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Chicago, Illinois 60657
Principal Investigator: Kenneth Candido, MD
Phone: 773-296-7937
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from
Chicago, IL
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Cleveland, Ohio 44195
Principal Investigator: Shrif Costandi, MD
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from
Cleveland, OH
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Dallas, Texas 75240
Principal Investigator: Muhammad Zulqarnain, MS
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from
Dallas, TX
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Edgewood, Kentucky 41017
Principal Investigator: Pragya Gupta, MD
Phone: 859-757-1359
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from
Edgewood, KY
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Edmond, Oklahoma 73013
Principal Investigator: Douglas Beall, MD
Phone: 405-601-2325
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from
Edmond, OK
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Fort Lauderdale, Florida 33316
Principal Investigator: Kevin Shrock, MD
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from
Fort Lauderdale, FL
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Houston, Texas 77004
Principal Investigator: Daneshvari R Solanki, MD
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from
Houston, TX
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Kansas City, Kansas 66160
Principal Investigator: Dawood Sayed, MD
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from
Kansas City, KS
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Madison, Wisconsin 53792
Principal Investigator: Alaa Abd-Elsayed, MD
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from
Madison, WI
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Miami, Florida 33135
Principal Investigator: Jesse Shaw, MD
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from
Miami, FL
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Mobile, Alabama 36605
Principal Investigator: Christopher Lambert, MD
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from
Mobile, AL
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Overland Park, Kansas 66210
Principal Investigator: Mayank Gupta, MD
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from
Overland Park, KS
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Phoenix, Arizona 85018
Principal Investigator: Matthew Doust, MD
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from
Phoenix, AZ
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San Antonio, Texas 78229
Principal Investigator: Richard Pollak, MD
Phone: 210-949-0807
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San Antonio, TX
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Santa Rosa, California 95401
Principal Investigator: Michael Yang, MD
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from
Santa Rosa, CA
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Scottsdale, Arizona 85258
Principal Investigator: Tory McJunkin, MD
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from
Scottsdale, AZ
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Shrewsbury, New Jersey 60657
Principal Investigator: Sean Li, MD
Phone: 732-930-2423
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from
Shrewsbury, NJ
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Tyler, Texas 75701
Principal Investigator: Aaron Calodney, MD
Phone: 903-531-0566
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Tyler, TX
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Washington, District of Columbia 22205
Principal Investigator: Mehul Desai, MD
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from
Washington,
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Winston-Salem, North Carolina 27103
Principal Investigator: Leonardo Kapural, MD, PhD
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from
Winston-Salem, NC
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