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

NCT ID: NCT05956509

Last Updated: 2024-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-12

Study Completion Date

2024-06-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Upper Limb Spasticity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part 1: ABBV-950 Dose A

Participants will receive ABBV-Dose A on Day 1.

Group Type EXPERIMENTAL

ABBV-950

Intervention Type BIOLOGICAL

Intramuscular (IM) Injection

Part 1: Placebo for ABBV-950 Dose A

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

Group Type PLACEBO_COMPARATOR

Placebo for ABBV-950

Intervention Type DRUG

Intramuscular (IM) Injection

Part 1: ABBV-950 Dose B

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

Group Type EXPERIMENTAL

ABBV-950

Intervention Type BIOLOGICAL

Intramuscular (IM) Injection

Part 1: Placebo for ABBV-950 Dose B

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

Group Type PLACEBO_COMPARATOR

Placebo for ABBV-950

Intervention Type DRUG

Intramuscular (IM) Injection

Part 1: ABBV-950 Dose C

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

Group Type EXPERIMENTAL

ABBV-950

Intervention Type BIOLOGICAL

Intramuscular (IM) Injection

Part 1: Placebo for ABBV-950 Dose C

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

Group Type PLACEBO_COMPARATOR

Placebo for ABBV-950

Intervention Type DRUG

Intramuscular (IM) Injection

Part 2: BOTOX Dose A

Participants will receive BOTOX Dose A on Day 1.

Group Type ACTIVE_COMPARATOR

BOTOX

Intervention Type BIOLOGICAL

Intramuscular (IM) Injection

Part 2: ABBV-950 Dose A

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

Group Type EXPERIMENTAL

ABBV-950

Intervention Type BIOLOGICAL

Intramuscular (IM) Injection

Part 2: ABBV-950 Dose B

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

Group Type EXPERIMENTAL

ABBV-950

Intervention Type BIOLOGICAL

Intramuscular (IM) Injection

Part 2: ABBV-950 Dose C

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

Group Type EXPERIMENTAL

ABBV-950

Intervention Type BIOLOGICAL

Intramuscular (IM) Injection

Part 2: Placebo for ABBV-950

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

Group Type PLACEBO_COMPARATOR

Placebo for ABBV-950

Intervention Type DRUG

Intramuscular (IM) Injection

Interventions

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ABBV-950

Intramuscular (IM) Injection

Intervention Type BIOLOGICAL

BOTOX

Intramuscular (IM) Injection

Intervention Type BIOLOGICAL

Placebo for ABBV-950

Intramuscular (IM) Injection

Intervention Type DRUG

Other Intervention Names

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Botulinum toxin type A OnabotulinumtoxinA

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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North County Neurology Associates /ID# 256333

Carlsbad, California, United States

Site Status

Rancho Los Amigos National Rehabilitation center /ID# 255335

Downey, California, United States

Site Status

Neuro Pain Medical Center /ID# 256036

Fresno, California, United States

Site Status

New England Institute for Clinical Research /ID# 255020

Stamford, Connecticut, United States

Site Status

MedStar National Rehabilitation Hospital /ID# 255630

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

Site Status

JEM Research Institute /ID# 258782

Lake Worth, Florida, United States

Site Status

Kansas Institute of Research /ID# 254998

Overland Park, Kansas, United States

Site Status

University of Missouri Hospital /ID# 255310

Columbia, Missouri, United States

Site Status

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

Dallas, Texas, United States

Site Status

Countries

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United States

Related Links

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https://www.abbvieclinicaltrials.com/study/?id=M23-499

Related Info

Other Identifiers

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M23-499

Identifier Type: -

Identifier Source: org_study_id

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