The Effects of Early and Late Injection of Botulinum Toxin Type A on Upper Limb Function in Patients With Stroke

NCT02580838 | Unknown Phase 3 DMC

• 1 other identifier: B-BR-102-032
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine whether early use of OnabotulinumtoxinA is more effective to improve functional outcomes of upper limb in patients with stroke.

Conditions

Stroke

Keywords

Stroke; Spasticity; OnabotulinumtoxinA

Outcome Measures

Primary Outcomes (1)

• Modified Ashworth Scale

  change from baseline Modified Ashworth Scale at 4 weeks

Study Arms (3)

early OnabotulinumtoxinA group

EXPERIMENTAL

OnabotulinumtoxinA will be injected immediately when spasticity develop in early OnabotulinumtoxinA group.

Drug: OnabotulinumtoxinA

late OnabotulinumtoxinA group

ACTIVE COMPARATOR

OnabotulinumtoxinA will be injected at 6 months after emergence of spasticity in late OnabotulinumtoxinA group.

Drug: OnabotulinumtoxinA

no OnabotulinumtoxinA group

NO INTERVENTION

OnabotulinumtoxinA will not be injected for this group.

Interventions

OnabotulinumtoxinA DRUG

Early OnabotulinumtoxinA group will receive OnabotulinumtoxinA injection when their spasticity develop, late OnabotulinumtoxinA group will have injection at 6 months after emergence of spasticity, the third group will not have OnabotulinumtoxinA intervention.

Also known as: Botox

early OnabotulinumtoxinA group; late OnabotulinumtoxinA group

Eligibility Criteria

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

You may qualify if:

• stroke affecting one body side
• spasticity develops after stroke

You may not qualify if:

• musculoskeletal conditions that affected upper limb function prior to stroke
• concurrent use of anti-spasticity medications
• patients with neuromuscular junction or myopathic disorders such as myasthenia gravis or others
• patients with a known allergy to any onabotulinumtoxinA or to any of the excipients of onabotulinumtoxinA (such as human serum albumin)
• patients who are pregnant or may become pregnant at the time of the proposed injection

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital

Tainan, 138, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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

Study Officials

• Richard Lin

  Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Lin

CONTACT

886-6-2353535; richelin@mail.ncku.edu.tw

Richard Lin

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2015
• First Posted: October 20, 2015
• Study Start: August 1, 2015
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2025
• Last Updated: September 30, 2022

Record last verified: 2015-10

Locations

TW (1)