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

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

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 Overview

• Status: Terminated
• Conditions: Upper Limb Spasticity
• Intervention / Treatment: Biological: ABBV-950; Drug: Placebo for ABBV-950; Biological: BOTOX

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Carlsbad, California, United States, 92011-4213
      • North County Neurology Associates /ID# 256333
    • Downey, California, United States, 90242
      • Rancho Los Amigos National Rehabilitation center /ID# 255335
    • Fresno, California, United States, 93710-5473
      • Neuro Pain Medical Center /ID# 256036
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • New England Institute for Clinical Research /ID# 255020
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar National Rehabilitation Hospital /ID# 255630
  • Florida
    • Lake Worth, Florida, United States, 33462-1141
      • JEM Research Institute /ID# 258782
  • Kansas
    • Overland Park, Kansas, United States, 66211-1363
      • Kansas Institute of Research /ID# 254998
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri Hospital /ID# 255310
  • Texas
    • Dallas, Texas, United States, 75235-7709
      • Ut Southwestern Medical Center /Parkland Health and Hospital System /Id# 255328

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: ABBV-950 Dose A; Participants will receive ABBV-Dose A on Day 1.	Biological: ABBV-950; Intramuscular (IM) Injection; Other Names: Botulinum toxin type A
Placebo Comparator: Part 1: Placebo for ABBV-950 Dose A; Participants will receive placebo for ABBV-950 on Day 1.	Drug: Placebo for ABBV-950; Intramuscular (IM) Injection
Experimental: Part 1: ABBV-950 Dose B; Participants will receive ABBV-950 Dose B on Day 1.	Biological: ABBV-950; Intramuscular (IM) Injection; Other Names: Botulinum toxin type A
Placebo Comparator: Part 1: Placebo for ABBV-950 Dose B; Participants will receive placebo for ABBV-950 on Day 1.	Drug: Placebo for ABBV-950; Intramuscular (IM) Injection
Experimental: Part 1: ABBV-950 Dose C; Participants will receive ABBV-950 Dose C on Day 1.	Biological: ABBV-950; Intramuscular (IM) Injection; Other Names: Botulinum toxin type A
Placebo Comparator: Part 1: Placebo for ABBV-950 Dose C; Participants will receive placebo for ABBV-950 on Day 1.	Drug: Placebo for ABBV-950; Intramuscular (IM) Injection
Active Comparator: Part 2: BOTOX Dose A; Participants will receive BOTOX Dose A on Day 1.	Biological: BOTOX; Intramuscular (IM) Injection; Other Names: OnabotulinumtoxinA
Experimental: Part 2: ABBV-950 Dose A; Participants will receive ABBV-950 Dose A on Day 1.	Biological: ABBV-950; Intramuscular (IM) Injection; Other Names: Botulinum toxin type A
Experimental: Part 2: ABBV-950 Dose B; Participants will receive ABBV-950 Dose B on Day 1.	Biological: ABBV-950; Intramuscular (IM) Injection; Other Names: Botulinum toxin type A
Experimental: Part 2: ABBV-950 Dose C; Participants will receive ABBV-950 Dose C on Day 1.	Biological: ABBV-950; Intramuscular (IM) Injection; Other Names: Botulinum toxin type A
Placebo Comparator: Part 2: Placebo for ABBV-950; Participants will receive placebo for ABBV-950 on Day 1.	Drug: Placebo for ABBV-950; Intramuscular (IM) Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2024
• Primary Completion (Actual): June 2, 2024
• Study Completion (Actual): June 2, 2024

Study Registration Dates

• First Submitted: July 14, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Stroke; Spasticity; Botulinum toxin type A; Upper Limb Spasticity; ABBV-950
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Spasticity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: M23-499

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes