Safety and Efficacy of XT-150 for Treatment of Neuropathic Pain
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Neuropathic Pain
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Dose escalation by cohort following safety reviewsMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Placebo and active drug are identical in appearance. Randomization will be provided to an unblinded pharmacist. Dosing and clinical assessments will be blinded.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
XT-150 has been safe and well tolerated in clinical studies of intra-articular knee injections for osteoarthritis. This is the initial study of XT-150 for treatment of neuropathic pain. For this indication XT-150 must be administered by intrathecal injection. Doses used in the osteoarthritis studies...
XT-150 has been safe and well tolerated in clinical studies of intra-articular knee injections for osteoarthritis. This is the initial study of XT-150 for treatment of neuropathic pain. For this indication XT-150 must be administered by intrathecal injection. Doses used in the osteoarthritis studies will be studied for neuropathic pain. Upon safety reviews, doses will be increased by cohorts. The study is placebo controlled and blinded.
Tracking Information
- NCT #
- NCT04466410
- Collaborators
- Not Provided
- Investigators
- Study Director: Stephen Collins, MD/PhD Xalud Therapeutics, Inc.
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