A Pilot Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368, a FAAH/MAGL Inhibitor, in Participants With Post-Stroke Spasticity (The STIPS Study)
NCT07704840 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2026-07-29
Summary
The goal of this clinical trial is to learn if the drug BMS-986368 works to treat post stroke spasticity in adults who have had a stroke. BMS-986368 is a designed to increase natural compounds in the body that may help calm nerves that cause muscles to be tight or spasm. The study will also learn about the safety of drug BMS-986368
Conditions
- Post-Stroke Spasticity
Interventions
- DRUG
-
Administration of BMS-986368
Administration of BMS-986368. Specified dose on specified days
- DRUG
-
Interventions: Drug: Placebo
Sponsors & Collaborators
- collaborator INDUSTRY
-
Alberto Esquenazi
lead OTHER
Principal Investigators
-
Alberto Esquenazi, MD · Thomas Jefferson University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-31
- Primary Completion
- 2027-06-30
- Completion
- 2027-08-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Comparative Efficacy of Three Preparations of Botox-A in Treating Spasticity
NCT00178646 ·Status: COMPLETED ·Phase: PHASE4
-
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Chinese Subjects With Post-stroke Upper Limb Spasticity
NCT01153815 ·Status: COMPLETED ·Phase: PHASE3
-
Study of the Effects on Motor Recovery of Early Post-stroke Spasticity Treatment
NCT02462317 ·Status: COMPLETED ·Phase: PHASE4
-
Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury
NCT03992404 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Study of Intramuscular Injections of ABBV-950 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Upper Limb Spasticity
NCT05956509 ·Status: TERMINATED ·Phase: PHASE1
-
OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity
NCT02145676 ·Status: TERMINATED ·Phase: PHASE3
-
BTX-A and Mirror Therapy for Chronic Stroke Spasticity
NCT07331844 ·Status: COMPLETED ·Phase: NA
-
Phase III Study of Botulax® to Treat Post Stroke Upper Limb Spasticity
NCT01915459 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of SPARC0921 in Subjects With Spasticity
NCT01457352 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Responsiveness of Seven Functional Tasks in Patients With Poststroke Upper Limb Spasticity With Botulinum Toxin Type A Treatment
NCT00651690 ·Status: COMPLETED ·Phase: PHASE2
-
Dry Needling and Botulinum Toxin in the Management of Poststroke Spasticity
NCT03747900 ·Status: COMPLETED ·Phase: NA
-
BOTOX® Economic Spasticity Trial (BEST)
NCT00549783 ·Status: COMPLETED ·Phase: PHASE4
-
Botox vs. Baclofen for Upper Limb Spasticity
NCT00280280 ·Status: TERMINATED ·Phase: PHASE1
-
Safety Study of Botulinum Toxin Type A in Post-Upper Limb Stroke Patients With Reduced Lung Function
NCT00076687 ·Status: COMPLETED ·Phase: PHASE2
-
Early Use of Botulinum Toxin in Spasticity Post Stroke.
NCT01882556 ·Status: COMPLETED ·Phase: PHASE2
-
Study of a New Generation Botulinum Toxin A2NTX to Treat Spasticity After Stroke
NCT01910363 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
The Effect of Ultrasound-Guided Botulinum Toxin Injections on Pain, Functionality, Spasticity, and Range of Motion in Patients With Post-Stroke Upper Extremity Spasticity
NCT05887479 ·Status: WITHDRAWN ·Phase: PHASE4
-
Comparison of Safety and Efficacy of Tizanidine Hydrochloride Capsules Versus Zanaflex® (Tizanidine Hydrochloride Tablets) Taken While in the Fed State (Just After a Meal) and in the Fasted State (Before a Meal) in Patients With Moderate to Severe Spasticity.
NCT00047580 ·Status: COMPLETED ·Phase: PHASE3
-
BOTOX® Versus Zanaflex® for the Treatment of Post-Stroke or Traumatic Brain Injury Upper Limb Spasticity
NCT00430196 ·Status: COMPLETED ·Phase: PHASE4
-
A Multicenter, Open-label, Single Dose Study of the Safety and Efficacy of GSK1358820 (Botulinum Toxin Type A) in Chinese Subjects With Post-stroke Focal Upper Limb Spasticity
NCT01205451 ·Status: COMPLETED ·Phase: PHASE3
-
Phenol and Botulinum Toxin vs Botulinum Toxin Alone for Post-Stroke Upper-Limb Spasticity
NCT07440173 ·Status: NOT_YET_RECRUITING ·Phase: PHASE4
-
Botulinim Toxin Type A Injections by Different Guidance in Stroke Patients With Spasticity on Lower Extremities
NCT02469948 ·Status: UNKNOWN ·Phase: PHASE3
-
Efficiency of Botulinum Toxin Injection for Spastic Equinovarus Foot in Post Stroke Hemiparetic Patients
NCT03405948 ·Status: COMPLETED ·Phase: NA
-
Randomized DB Controlled Trial of Botulinum Toxin A in Hemiplegic Shoulder Pain and Spasticity
NCT00661089 ·Status: COMPLETED ·Phase: NA
-
The Impact of Botox® During Robotic Rehabilitation of the Wrist Following Stroke
NCT01088230 ·Status: COMPLETED ·Phase: PHASE1/PHASE2