Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults (RePRIEVE-CM)
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|ClinicalTrials.gov Identifier: NCT03727100|
Recruitment Status : Active, not recruiting
First Posted : November 1, 2018
Last Update Posted : December 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lumbosacral Radiculopathy||Combination Product: Clonidine Micropellets Other: Sham||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||207 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Clonidine Micropellet vs Sham-Control|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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 :||December 14, 2019|
|Estimated Study Completion Date :||January 18, 2020|
Active Comparator: Clonidine Micropellets
single dose injection into the lumbar epidural space
Combination Product: Clonidine Micropellets
Sham Comparator: Sham Control
non-epidural needle placement
- 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.
- 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.
- 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.
- Difference in Rescue medication consumption [ Time Frame: Baseline to day 30 ]Consumption from baseline through day 30
- Percent of subjects with significant improvement in pain [ Time Frame: Baseline to day 30 ]50 percent improvement in pain from baseline to day 30
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
|Principal Investigator:||Christopher Gilligan, MD||Brigham and Women's Hospital|