OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity

• ClinicalTrials.gov Identifier: NCT02145676
• Recruitment Status: Terminated
• First Posted: May 23, 2014
• Results First Posted: February 14, 2017
• Last Update Posted: April 12, 2017
• Sponsor: Allergan
• Information provided by (Responsible Party): Allergan

Study Description

Brief Summary:

This is a safety and efficacy study of onabotulinumtoxinA in poststroke patients with upper limb spasticity.

Condition or disease	Intervention/treatment	Phase
Muscle Spasticity; Stroke	Biological: onabotulinumtoxinA; Drug: placebo (normal saline)	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 53 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Study Start Date: May 2014
• Actual Primary Completion Date: December 2015
• Actual Study Completion Date: December 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: onabotulinumtoxinA 500U; OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.	Biological: onabotulinumtoxinA; OnabotulinumtoxinA injected into predefined muscles of the study limb on Day 1.; Other Names: BOTOX®; botulinum toxin type A
Experimental: onabotulinumtoxinA 300U; OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.	Biological: onabotulinumtoxinA; OnabotulinumtoxinA injected into predefined muscles of the study limb on Day 1.; Other Names: BOTOX®; botulinum toxin type A
Placebo Comparator: placebo (normal saline); Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.	Drug: placebo (normal saline); Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Elbow Flexors Using a 6-Point Scale [ Time Frame: Baseline, Week 6 ]
   The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the elbow flexors by passively moving the elbow flexor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.

Secondary Outcome Measures :

1. Change From Baseline in the MAS-B Score of Shoulder Adductors Using a 6-Point Scale [ Time Frame: Baseline, Week 6 ]
   The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the shoulder adductors by passively moving the shoulder adductor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
2. Change From Baseline in Pain on an 11-Point Scale [ Time Frame: Baseline, Week 6 ]
   The patient is asked to select a number that best describes his/her pain in the treated areas of the study limb on an 11-point scale from 0 = "no pain" to 10 = "pain as bad as can be imagined". Patients are instructed to recall their average pain in the study limb during the 48-hour period prior to the visit. Patients with a baseline pain score >0 are included in the analyses. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
3. Change From Baseline in the Dressing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL) [ Time Frame: Baseline, Week 6 ]
   The SIA-UL asks the patient to assess the impact of upper limb spasticity in his/her daily life on a 19-item scale. The scale covers impacts on activities of dressing, showering/bathing, and self-care. The SIA score ranged from 0 (not at all difficult) to 4 (extremely difficult) for each question. The dressing domain was calculated based on the average of 2 questions.
4. Change From Baseline in the Showering/Bathing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL) [ Time Frame: Baseline, Week 6 ]
   The SIA-UL asks the patient to assess the impact of upper limb spasticity his/her daily life on a 19-item scale. The scale covers impacts on activities of dressing, showering/bathing, and self-care. The SIA score ranged from 0 (not at all difficult) to 4 (extremely difficult) for each question. The showering/bathing domain was based on a single question.
5. Change From Baseline in the Self-Care Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL) [ Time Frame: Baseline, Week 6 ]
   The SIA-UL asks the patient to assess the impact of upper limb spasticity in his/her daily life on a 19-item scale. The scale covers impacts on activities of dressing, showering/bathing, and self-care. The SIA score ranged from 0 (not at all difficult) to 4 (extremely difficult) for each question. The self-care domain was calculated based on the average of 4 questions.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Upper limb spasticity in the elbow and shoulder due to stroke, with the most recent stroke at least 3 months ago

Exclusion Criteria:

• Spasticity in the non-study upper limb that requires treatment
• Presence of fixed contractures in of the study muscles in elbow or shoulder
• Profound atrophy of muscles to be injected
• 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, use of casting or dynamic splinting or constraint-induced movement therapy (CIMT) for the study limb within 3 months
• Ultrasound therapy, electrical stimulation, or acupuncture in the study limb within 1 month
• Condition other than stroke contributing to upper limb spasticity
• Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, and/or amyotrophic lateral sclerosis

Contacts and Locations

Locations

United States, Kansas

Overland Park, Kansas, United States

Canada, Quebec

Montreal, Quebec, Canada

Sponsors and Collaborators

Allergan

Investigators

• Study Director: Medical Director; Allergan

More Information

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT02145676
• Other Study ID Numbers: 191622-127; 2013-002346-37 ( EudraCT Number )
• First Posted: May 23, 2014
• Results First Posted: February 14, 2017
• Last Update Posted: April 12, 2017
• Last Verified: March 2017

Additional relevant MeSH terms:

Muscle Spasticity; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; Acetylcholine Release Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Neuromuscular Agents; Peripheral Nervous System Agents