Study of Intramuscular Injections of ABBV-950 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Upper Limb Spasticity

Upper Limb Spasticity Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05956509
• Other study ID #: M23-499
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: January 12, 2024
• Est. completion date: November 16, 2026

Study information

• Verified date: April 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 297
• Est. completion date: November 16, 2026
• Est. primary completion date: November 16, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosis of upper limb spasticity due to stroke, with most recent stroke occurring at least 12 weeks prior to the Screening visit.
• Modified Ashworth Scale-Bohannon (MAS-B) score of >= 3 in the wrist flexors, and a score of >= 1+ in the finger flexors and MAS-B score of >= 2 elbow flexors at both Screening and Visit 2 (Baseline).

Exclusion Criteria:

• Additional strokes in the 12 weeks preceding the most recent stroke and in the opinion of the investigator, is not at significant risk of experiencing another stroke during the study period.
• Spasticity in the contralateral upper limb that requires treatment.
• Presence of fixed contractures in muscles of wrist, elbow, fingers.
• Botulinum toxin treatment of any serotype in the 20 weeks prior to Day for upper limb spasticity and in the 12 weeks prior to Day 1 for any indication other than upper limb spasticity.
• Previous surgical intervention, nerve block, or muscle block for the treatment of spasticity in the study limb in the last 12 months.
• Injection of corticosteroids or anesthetics in the study limb within 12 weeks.
• Casting of the upper limbs within 12 weeks.
• Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, and/or amyotrophic lateral sclerosis.

Related Conditions & MeSH terms

• Muscle Spasticity
• Upper Limb Spasticity

Intervention

Biological:
• ABBV-950
Intramuscular (IM) Injection
• BOTOX
Intramuscular (IM) Injection

Drug:
• Placebo for ABBV-950
Intramuscular (IM) Injection

Locations

Country	Name	City	State
United States	North County Neurology Associates /ID# 256333	Carlsbad	California
United States	University of Missouri Hospital /ID# 255310	Columbia	Missouri
United States	Rancho Los Amigos National Rehabilitation center /ID# 255335	Downey	California
United States	Neuro Pain Medical Center /ID# 256036	Fresno	California
United States	JEM Research Institute /ID# 258782	Lake Worth	Florida
United States	Kansas Institute of Research /ID# 254998	Overland Park	Kansas
United States	New England Institute for Clinical Research /ID# 255020	Stamford	Connecticut
United States	MedStar National Rehabilitation Hospital /ID# 255630	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Wrist Modified Ashworth Scale-Bohannon (MAS-B)	MAS-B measures muscle tone based on grading the resistance encountered in a specific muscle group by means of passively moving a limb through its range of motion at a study-specified velocity. Score ranges from 0 (No increase in muscle tone) through 4 (Affected part(s) rigid in flexion or extension).	Up to Week 6
Primary	Number of Participants Experiencing Adverse Events	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.	Up to Week 24
Secondary	Change in Clinician Global Impression of Change (CGI-C) Score	CGI-C is a 9-point rating scale used to measure the clinician's impression of overall treatment response since the first dose of study intervention. CGI-C scores range from -4 = very marked worsening to +4 = very marked improvement.	Up to Week 6
Secondary	Change in Clinician Global Impression of Severity (CGI-S) Score	CGI-S is a 5-point rating scale used to measure the clinician's or trained personnel's impression of the current severity of the participant's upper limb spasticity. Scores range from 0 = no spasticity to 4 = very severe.	Up to Week 6
Secondary	Percentage of Participants Achieving Wrist MAS-B Responder Status	MAS-B measures muscle tone based on grading the resistance encountered in a specific muscle group by means of passively moving a limb through its range of motion at a study-specified velocity. Score ranges from 0 (No increase in muscle tone) through 4 (Affected part(s) rigid in flexion or extension). Responder is defined as participant with >= 1 grade improvement from baseline.	Up to Week 6

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