Upper Limb Spasticity
Conditions
Keywords
Spasticity, Upper Limb Spasticity, Stroke, ABBV-950, Botulinum toxin type A
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.
Interventions
BIOLOGICALABBV-950
Intramuscular (IM) Injection
BIOLOGICALBOTOX
Intramuscular (IM) Injection
DRUGPlacebo for ABBV-950
Intramuscular (IM) Injection
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Wrist Modified Ashworth Scale-Bohannon (MAS-B) | Up to Week 6 | 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). |
| Number of Participants Experiencing Adverse Events | Up to Week 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinician Global Impression of Change (CGI-C) Score | Up to Week 6 | 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. |
| Change in Clinician Global Impression of Severity (CGI-S) Score | Up to Week 6 | 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. |
| Percentage of Participants Achieving Wrist MAS-B Responder Status | Up to Week 6 | 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. |
Countries
United States
Outcome results
None listed