OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity

NCT02145676 | Terminated Phase 3 Results DMC

• 2 other identifiers: 191622-1272013-002346-37
• Study Type: interventional
• Target: 53
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Muscle Spasticity; Stroke

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Elbow Flexors Using a 6-Point Scale

  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.

  Baseline, Week 6

Secondary Outcomes (5)

• Change From Baseline in the MAS-B Score of Shoulder Adductors Using a 6-Point Scale

  Baseline, Week 6

• Change From Baseline in Pain on an 11-Point Scale

  Baseline, Week 6

• Change From Baseline in the Dressing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)

  Baseline, Week 6

• Change From Baseline in the Showering/Bathing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)

  Baseline, Week 6

• Change From Baseline in the Self-Care Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)

  Baseline, Week 6

Study Arms (3)

onabotulinumtoxinA 500U

EXPERIMENTAL

OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.

Biological: onabotulinumtoxinA

onabotulinumtoxinA 300U

EXPERIMENTAL

OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.

Biological: onabotulinumtoxinA

placebo (normal saline)

PLACEBO COMPARATOR

Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.

Drug: placebo (normal saline)

Interventions

onabotulinumtoxinA BIOLOGICAL

OnabotulinumtoxinA injected into predefined muscles of the study limb on Day 1.

Also known as: BOTOX®, botulinum toxin type A

onabotulinumtoxinA 300U; onabotulinumtoxinA 500U

placebo (normal saline) DRUG

Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.

placebo (normal saline)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (2)

Unknown Facility

Overland Park, Kansas, United States

Location

Unknown Facility

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Muscle Spasticity; Stroke

Interventions

Botulinum Toxins, Type A; Saline Solution

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; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: May 23, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 12, 2017
• Results First Posted: February 14, 2017

Record last verified: 2017-03

Locations

US (1); CA (1)