Clinical trial NCT05956509: Study of Intramuscular Injections of ABBV-950 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Upper Limb Spasticity
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Upper Limb Spasticity
Keywords: Spasticity
Upper Limb Spasticity
Stroke
ABBV-950
Botulinum toxin type A
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-07-21
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Wrist Modified Ashworth Scale-Bohannon (MAS-B)
timeFrame: Up to Week 6
measure: Number of Participants Experiencing Adverse Events
timeFrame: Up to Week 24
Secondary outcomes:
measure: Change in Clinician Global Impression of Change (CGI-C) Score
timeFrame: Up to Week 6
measure: Change in Clinician Global Impression of Severity (CGI-S) Score
timeFrame: Up to Week 6
measure: Percentage of Participants Achieving Wrist MAS-B Responder Status
timeFrame: Up to Week 6
Other outcomes:
Locations:
city: Carlsbad
country: United States
facility: North County Neurology Associates /ID# 256333
state: California
city: Downey
country: United States
facility: Rancho Los Amigos National Rehabilitation center /ID# 255335
state: California
city: Fresno
country: United States
facility: Neuro Pain Medical Center /ID# 256036
state: California
city: Stamford
country: United States
facility: New England Institute for Clinical Research /ID# 255020
state: Connecticut
city: Washington
country: United States
facility: MedStar National Rehabilitation Hospital /ID# 255630
state: District of Columbia
city: Lake Worth
country: United States
facility: JEM Research Institute /ID# 258782
state: Florida
city: Overland Park
country: United States
facility: Kansas Institute of Research /ID# 254998
state: Kansas
city: Columbia
country: United States
facility: University of Missouri Hospital /ID# 255310
state: Missouri
city: Dallas
country: United States
facility: Ut Southwestern Medical Center /Parkland Health and Hospital System /Id# 255328
state: Texas
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: