Comparative Efficacy of Three Preparations of Botox-A in Treating Spasticity

NCT00178646 | Completed Phase 4 Results

• 1 other identifier: HSC-MS-01-103
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

Brief Summary

The study seeks to compare the effectiveness of three preparations of BOTOX-A® in treating muscle tightness and spasms in the feet and ankles of people with stroke.

Conditions

Stroke; Brain Injuries; Spasticity

Keywords

Stroke; Brain Injuries; Spasticity; Botulinum Toxins

Outcome Measures

Primary Outcomes (5)

• Spastic Hypertonia as Measured by the Ashworth Scale

  The Ashworth Scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. Score on the Ashworth scores ranges from 0-4, with 4 being the worst: 0 - No increase in muscle tone 1. \- Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 2. \- More marked increase in muscle tone through most of the range of motion, but affected limb easily flexed 3. \- Considerable increase in muscle tone, passive movement difficult 4. \- Limb in flexion or extension

  Baseline

• Spastic Hypertonia as Measured by the Ashworth Scale

  The Ashworth Scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. Score on the Ashworth scores ranges from 0-4, with 4 being the worst: 0: No increase in muscle tone 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 2. More marked increase in muscle tone through most of the range of motion, but affected limb easily flexed 3. Considerable increase in muscle tone, passive movement difficult 4. Limb in flexion or extension

  Four weeks

• Spastic Hypertonia as Measured by the Ashworth Scale

  The Ashworth Scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. Score on the Ashworth scores ranges from 0-4, with 4 being the worst: 0: No increase in muscle tone 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 2. More marked increase in muscle tone through most of the range of motion, but affected limb easily flexed 3. Considerable increase in muscle tone, passive movement difficult 4. Limb in flexion or extension

  Eight Weeks

• Spastic Hypertonia as Measured by the Ashworth Scale

  The Ashworth Scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. Score on the Ashworth scores ranges from 0-4, with 4 being the worst: 0: No increase in muscle tone 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 2. More marked increase in muscle tone through most of the range of motion, but affected limb easily flexed 3. Considerable increase in muscle tone, passive movement difficult 4. Limb in flexion or extension

  Twelve Weeks

• Spastic Hypertonia as Measured by the Ashworth Scale

  The Ashworth Scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. Score on the Ashworth scores ranges from 0-4, with 4 being the worst: 0: No increase in muscle tone 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 2. More marked increase in muscle tone through most of the range of motion, but affected limb easily flexed 3. Considerable increase in muscle tone, passive movement difficult 4. Limb in flexion or extension

  Sixteen Weeks

Secondary Outcomes (2)

• Range of Motion as Measured by Goniometry

  Baseline

• Range of Motion as Measured by Goniometry

  8 weeks

Study Arms (3)

1 - Low Volume, High Dose

EXPERIMENTAL

Botox (onabotulinumtoxinA), 150 units prepared as 100 units per 1 ml of preservative-free normal saline

Drug: Botox

2 - High Volume, High Dose

ACTIVE COMPARATOR

Botox (onabotulinumtoxinA), 150 units prepared as 50 units per 1 ml of preservative-free normal saline

Drug: Botox

3 - High Volume, Low Dose

OTHER

Botox (onabotulinumtoxinA), 75 units prepared as 25 units per 1 ml of preservative-free normal saline

Drug: Botox

Interventions

Botox DRUG

Botox 75-150 units, single treatment only

Also known as: generic name: botulinum toxin type A

1 - Low Volume, High Dose; 2 - High Volume, High Dose; 3 - High Volume, Low Dose

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Spasticity resulting from ABI (stroke, including vascular malformations, traumatic brain injury)
• Ashworth Score (resting) of at least 2 of the primary ankle plantarflexor (gastrocnemius)
• At least 12 years of age

You may not qualify if:

• Hypersensitivity or allergy to botulinum toxin
• History of myasthenia gravis or other neuromuscular disease
• Current use of aminoglycosides
• Botulinum toxin or phenol injection to study limb within six months prior to recruitment
• Current use of other spasmolytic drug, such as diazepam, baclofen, dantrolene, tizanidine
• Presence of contracture or significant muscle atrophy
• Pregnancy

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Allergan: collaborator

Study Sites (2)

Kessler Institute for Rehabiliation

West Orange, New Jersey, 07052, United States

Location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Francisco GE, Boake C, Vaughn A. Botulinum toxin in upper limb spasticity after acquired brain injury: a randomized trial comparing dilution techniques. Am J Phys Med Rehabil. 2002 May;81(5):355-63. doi: 10.1097/00002060-200205000-00007.

  PMID: 11964576 BACKGROUND

MeSH Terms

Conditions

Stroke; Brain Injuries; 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; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; 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

Results Point of Contact

• Title: Gerard E. Francisco
• Organization: UTHealth

Gerard.E.Francisco@uth.tmc.edu

7137975246

Study Officials

• Gerard E Francisco, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor and Chairman - Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: January 1, 2002
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: January 22, 2021
• Results First Posted: January 22, 2021

Record last verified: 2021-01

Locations

US (2)