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

Sollis Therapeutics

Status and phase: Completed; Phase 3

Conditions: Lumbosacral Radiculopathy

Treatments: Other: Sham; Combination Product: Clonidine Micropellets

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03727100

STX-015-18-01

Details and patient eligibility

About

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.

Enrollment: 207 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.
7. Subject must have failed at least one conservative therapy in two different categories.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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207 participants in 2 patient groups

Clonidine Micropellets

Active Comparator group

Description:

single dose injection into the lumbar epidural space

Treatment:

Combination Product: Clonidine Micropellets

Sham Control

Sham Comparator group

Description:

non-epidural needle placement

Treatment:

Other: Sham