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

S

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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