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OpenTrials
Completed

NCT Number: NCT03727100

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.

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Key information

Conditions

Lumbosacral Radiculopathy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sollis Clinical Study Site 36, Mobile, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria:

  • Be between 18 and 70 years of age (inclusive) at time the Informed Consent Form (ICF) is signed.
  • Diagnosis of unilateral radicular leg pain.
  • 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.
  • Understands the purpose and any risks associated with the procedure required for the study and is willing to participate in the study.
  • Agrees to follow study-specific medication requirements.
  • Be able to read, write, understand, and complete study-related tasks, and adequately communicate in English.
  • Subject must have failed at least one conservative therapy in two different categories.

Main Exclusion Criteria:

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

Treatment and study plan

Clonidine Micropellets

Combination Product

Injection

SHAM

Other

Injection

Primary outcomes

  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 60

    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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sollis Therapeutics, Inc.

Industry

Collaborators

  • Lotus Clinical Research, LLC

Registry information

Official study 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

Acronym: RePRIEVE-CM

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 1, 2018
Registry last updated
Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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