Study of Intramuscular Injections of ABBV-950 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Upper Limb Spasticity
Public ClinicalTrials.gov record NCT05956509. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Efficacy, and Tolerability of ABBV-950 for the Treatment of Upper Limb Spasticity in Adult Post-Stroke Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Spasticity is often observed as muscle tightness and stiffness in the upper and/or lower limbs. Upper limb spasticity can interfere with joint movement and its severity can range from mild to severe. Common causes of spasticity include cerebral palsy, traumatic brain injury, multiple sclerosis, spinal cord injury, and stroke. This study will assess how safe and effective ABBV-950 is in treating upper limb spasticity in adult post-stroke participants. Adverse events and change in symptoms will be assessed. ABBV-950 in an investigational drug being developed for treating spasticity. This study is conducted in 2 parts. In Part 1, participants are assigned to receive different doses of ABBV-950 or placebo. There is 1 in 4 chance that participants will be assigned to receive placebo. In Part 2, participants will be randomly assigned to receive BOTOX, ABBV-950, or placebo. There is 1 in 5 chance for participants to receive placebo. Approximately 297 adult post-stroke participants with upper limb spasticity will be enrolled at approximately 50 sites in the United States. In Part 1, participants will receive intramuscular (IM) injections of ABBV-950 or placebo on Day 1. In Part 2, participants will receive IM injections of BOTOX, ABBV-950, or placebo on Day 1. All participants will be followed for 24 weeks. There may be higher treatment burden for participants in this trial compared to the standard of care. Participants will attend regular clinic visits during the study. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
Study identification
- NCT ID
- NCT05956509
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 1 participant
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 11, 2024
- Primary completion
- Jun 1, 2024
- Completion
- Jun 1, 2024
- Last update posted
- Jun 30, 2024
2024
United States locations
- U.S. sites
- 9
- U.S. states
- 7
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| North County Neurology Associates /ID# 256333 | Carlsbad | California | 92011-4213 | — |
| Rancho Los Amigos National Rehabilitation center /ID# 255335 | Downey | California | 90242 | — |
| Neuro Pain Medical Center /ID# 256036 | Fresno | California | 93710-5473 | — |
| New England Institute for Clinical Research /ID# 255020 | Stamford | Connecticut | 06905 | — |
| MedStar National Rehabilitation Hospital /ID# 255630 | Washington D.C. | District of Columbia | 20010 | — |
| JEM Research Institute /ID# 258782 | Lake Worth | Florida | 33462-1141 | — |
| Kansas Institute of Research /ID# 254998 | Overland Park | Kansas | 66211-1363 | — |
| University of Missouri Hospital /ID# 255310 | Columbia | Missouri | 65212 | — |
| Ut Southwestern Medical Center /Parkland Health and Hospital System /Id# 255328 | Dallas | Texas | 75235-7709 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05956509, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 30, 2024 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05956509 live on ClinicalTrials.gov.