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

NCT05956509 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: M23-499
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Upper Limb Spasticity

Keywords

Spasticity; Upper Limb Spasticity; Stroke; ABBV-950; Botulinum toxin type A

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in Clinician Global Impression of Change (CGI-C) Score

  Up to Week 6

• Change in Clinician Global Impression of Severity (CGI-S) Score

  Up to Week 6

• Percentage of Participants Achieving Wrist MAS-B Responder Status

  Up to Week 6

Study Arms (11)

Part 1: ABBV-950 Dose A

EXPERIMENTAL

Participants will receive ABBV-Dose A on Day 1.

Biological: ABBV-950

Part 1: Placebo for ABBV-950 Dose A

PLACEBO COMPARATOR

Participants will receive placebo for ABBV-950 on Day 1.

Drug: Placebo for ABBV-950

Part 1: ABBV-950 Dose B

EXPERIMENTAL

Participants will receive ABBV-950 Dose B on Day 1.

Biological: ABBV-950

Part 1: Placebo for ABBV-950 Dose B

PLACEBO COMPARATOR

Participants will receive placebo for ABBV-950 on Day 1.

Drug: Placebo for ABBV-950

Part 1: ABBV-950 Dose C

EXPERIMENTAL

Participants will receive ABBV-950 Dose C on Day 1.

Biological: ABBV-950

Part 1: Placebo for ABBV-950 Dose C

PLACEBO COMPARATOR

Participants will receive placebo for ABBV-950 on Day 1.

Drug: Placebo for ABBV-950

Part 2: BOTOX Dose A

ACTIVE COMPARATOR

Participants will receive BOTOX Dose A on Day 1.

Biological: BOTOX

Part 2: ABBV-950 Dose A

EXPERIMENTAL

Participants will receive ABBV-950 Dose A on Day 1.

Biological: ABBV-950

Part 2: ABBV-950 Dose B

EXPERIMENTAL

Participants will receive ABBV-950 Dose B on Day 1.

Biological: ABBV-950

Part 2: ABBV-950 Dose C

EXPERIMENTAL

Participants will receive ABBV-950 Dose C on Day 1.

Biological: ABBV-950

Part 2: Placebo for ABBV-950

PLACEBO COMPARATOR

Participants will receive placebo for ABBV-950 on Day 1.

Drug: Placebo for ABBV-950

Interventions

ABBV-950 BIOLOGICAL

Intramuscular (IM) Injection

Also known as: Botulinum toxin type A

Part 1: ABBV-950 Dose A; Part 1: ABBV-950 Dose B; Part 1: ABBV-950 Dose C; Part 2: ABBV-950 Dose A; Part 2: ABBV-950 Dose B; Part 2: ABBV-950 Dose C

BOTOX BIOLOGICAL

Intramuscular (IM) Injection

Also known as: OnabotulinumtoxinA

Part 2: BOTOX Dose A

Placebo for ABBV-950 DRUG

Intramuscular (IM) Injection

Part 1: Placebo for ABBV-950 Dose A; Part 1: Placebo for ABBV-950 Dose B; Part 1: Placebo for ABBV-950 Dose C; Part 2: Placebo for ABBV-950

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (9)

North County Neurology Associates /ID# 256333

Carlsbad, California, 92011-4213, United States

Location

Rancho Los Amigos National Rehabilitation center /ID# 255335

Downey, California, 90242, United States

Location

Neuro Pain Medical Center /ID# 256036

Fresno, California, 93710-5473, United States

Location

New England Institute for Clinical Research /ID# 255020

Stamford, Connecticut, 06905, United States

Location

MedStar National Rehabilitation Hospital /ID# 255630

Washington D.C., District of Columbia, 20010, United States

Location

JEM Research Institute /ID# 258782

Lake Worth, Florida, 33462-1141, United States

Location

Kansas Institute of Research /ID# 254998

Overland Park, Kansas, 66211-1363, United States

Location

University of Missouri Hospital /ID# 255310

Columbia, Missouri, 65212, United States

Location

Ut Southwestern Medical Center /Parkland Health and Hospital System /Id# 255328

Dallas, Texas, 75235-7709, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Muscle Spasticity; Stroke

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: July 21, 2023
• Study Start: January 12, 2024
• Primary Completion: June 2, 2024
• Study Completion: June 2, 2024
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

US (9)