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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03776318
Recruitment Status : Enrolling by invitation
First Posted : December 14, 2018
Last Update Posted : December 13, 2019
Sponsor:
Information provided by (Responsible Party):
Sollis Therapeutics, Inc.

Study Description
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Brief Summary:
Long-term follow-up study to evaluate the safety of clonidine micropellets up to 12 months post injection.

Condition or disease Intervention/treatment
Lumbosacral Radiculopathy Drug: Long-Term Safety Follow-up

Study Design
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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Actual Study Start Date : November 15, 2018
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety
Drug Information available for: Clonidine

Groups and Cohorts
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Group/Cohort Intervention/treatment
Safety Group
STX-015-18-01 Clonidine Micropellet long-term safety follow-up
 Drug: Long-Term Safety Follow-up
STX-015-18-01 long-term safety follow-up
Sham Control
STX-015-18-01 Sham control long-term safety follow-up
 Drug: Long-Term Safety Follow-up
STX-015-18-01 long-term safety follow-up


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Comprised of the first 100 subjects who completed all STX-015-18-01 study-related activities, age 18-70, male/female, reconfirmed eligible and signed informed consent.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03776318


Locations
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Sponsors and Collaborators
Sollis Therapeutics, Inc.
Investigators
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Principal Investigator: Christopher Gilligan, MD Brigham and Women's Hospital
More Information
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Responsible Party: Sollis Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03776318    
Other Study ID Numbers: STX-015-18-02
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases