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Completed

NCT Number: NCT03776318

Long-Term Follow-up Safety of Clonidine Micropellets

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

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Key information

Conditions

Lumbosacral Radiculopathy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sollis Clinical Study Site 36, Mobile, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Long-Term Safety Follow-up

Drug

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

Primary outcomes

  1. Change in Average and Worst NRS from Day 60 post injection to 12 months post injection

    Time frame: 10 months from completing Day 60 of the STX-015-18-01 study

    Difference in NRS pain scores from Day 60 of STX-015-18-01 to month 12 post injection

Secondary outcomes

  1. Incidence of Surgeries

    Time frame: 12 months from day of injection

    Difference in incidence of surgery, invasive treatment, and prescription medications due to radicular leg pain from Day 30 post injection to month 12 post injection from a cohort of subjects completing STX-015-18-01.

  2. Incidence of Invasive treatment received

    Time frame: 12 months from day of injection

    Difference in incidence of invasive treatment due to radicular leg pain from Day 30 post injection to month 12 post injection from a cohort of subjects completing STX-015-18-01

  3. Number of Prescription medications taken

    Time frame: 12 months from day of injection

    Difference in incidence of invasive treatment due to radicular leg pain from Day 30 post injection to month 12 post injection from a cohort of subjects completing STX-015-18-01

Sponsors and collaborators

Lead sponsor

Sollis Therapeutics, Inc.

Industry

Registry information

Official study title

A Multicenter, Randomized, Follow-up Study to Evaluate the Long-Term Safety of Clonidine Micropellets for the Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults

Acronym: RePRIEVE-CM-LT

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 14, 2018
Registry last updated
Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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