NCT05614648 (SERENITY CM) is a Phase 3 clinical trial of Clonidine Micropellets in Lumbosacral Radiculopathy, sponsored by Sollis Therapeutics, Inc..

Who is sponsoring NCT05614648?

NCT05614648 is sponsored by Sollis Therapeutics, Inc..

What drugs are being tested in NCT05614648?

Interventions in NCT05614648: Clonidine Micropellets, Tuohy epidural needle.

What condition does NCT05614648 study?

NCT05614648 studies Lumbosacral Radiculopathy.

Is NCT05614648 still recruiting?

NCT05614648 is currently terminated. Last updated 25 April 2024.

Last reviewed 2024-04-25 · How we verify

NCT05614648: SERENITY CM

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Sciatica Epidural Radiculopathy Experimental New Interventional TherapY Clonidine Micropellet

Terminated Phase 3 Last updated 25 April 2024

What this trial tests

Phase 3 trial testing Clonidine Micropellets in Lumbosacral Radiculopathy in 17 participants. Terminated before completion.

Timeline

19 June 2023

Primary endpoint
18 March 2024

30 March 2024

Quick facts

Lead sponsor	Sollis Therapeutics, Inc.
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	17
Start date	19 June 2023
Primary completion	18 March 2024
Estimated completion	30 March 2024
Sites	30 locations across United States

Drugs / interventions tested

Clonidine Micropellets — full drug profile →
Tuohy epidural needle

Conditions studied

Lumbosacral Radiculopathy — all drugs for Lumbosacral Radiculopathy →

Sponsor

Sollis Therapeutics, Inc. — full company profile →

Who can join

Adults 18 to 70, any sex, with Lumbosacral Radiculopathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Clonidine Micropellets

Trials testing the same drug.

NCT03727100 — Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults · Phase 3 · completed

Other recruiting trials for Lumbosacral Radiculopathy

Currently open trials in the same condition.

NCT07498140 — Procedural Framing and Epidural Steroid Injection Outcomes · NA · recruiting
NCT07264270 — Study to Evaluate Safety of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy · Phase 1 · recruiting
NCT05613569 — A Long-term, 3-Year, Follow-up Study for Patients Completing the KS-GIG-001-01 Study · active not recruiting

Other Sollis Therapeutics, Inc. trials

Trials by the same sponsor.

NCT03776318 — Long-Term Follow-up Safety of Clonidine Micropellets · completed
NCT03727100 — Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05614648 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sollis Therapeutics, Inc.
Last refreshed: 25 April 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05614648.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing