Long-Term Follow-up Safety of Clonidine Micropellets (RePRIEVE-CM-LT)

Sollis Therapeutics

Status: Completed

Conditions: Lumbosacral Radiculopathy

Treatments: Drug: Long-Term Safety Follow-up

Study type: Observational

Funder types: Industry

Identifiers

NCT03776318

STX-015-18-02

Details and patient eligibility

About

Long-term follow-up study to evaluate the safety of clonidine micropellets up to 12 months post injection.

Enrollment: 100 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject who have successfully completed all STX-015-18-01 study related activities, are reconfirmed to be eligible and have signed informed consent to participate.

Exclusion criteria

• Subjects who, in the opinion of the investigator, have demonstrated significant non-compliance with STX-015-18-01 study procedures.
• Subjects who were unblinded to their treatment in STX-015-18-01 study.

Trial design

100 participants in 2 patient groups

Safety Group

Description:

STX-015-18-01 Clonidine Micropellet long-term safety follow-up

Treatment:

Drug: Long-Term Safety Follow-up

Sham Control

Description:

STX-015-18-01 Sham control long-term safety follow-up

Treatment:

Drug: Long-Term Safety Follow-up