Observational Study of Botox® Treatment for Patients With Upper Limb Adult Spasticity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01387074
First received: June 30, 2011
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

This is a prospective, non-interventional, observational study to collect data on the use of botulinum toxin Type A in a routine setting in patients with upper limb adult spasticity.


Condition Intervention
Muscle Spasticity
Biological: botulinum toxin Type A

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Non-interventional, Observational Study of Botox® Treatment for Patients With Upper Limb Adult Spasticity

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The MAS assessed the degree of muscle tone during movement of the elbow compared to normal muscle tone using a 6-point scale where: 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 part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.

  • Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    The MAS assessed the degree of muscle tone during movement of the elbow compared to normal muscle tone using a 6-point scale where: 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 part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.

  • Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The MAS assessed the degree of muscle tone during movement of the wrist compared to normal muscle tone using a 6-point scale where: 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 part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.

  • Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    The MAS assessed the degree of muscle tone during movement of the wrist compared to normal muscle tone using a 6-point scale where: 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 part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.

  • Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The MAS assessed the degree of muscle tone during movement of the fingers compared to normal muscle tone using a 6-point scale where: 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 part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.

  • Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    The MAS assessed the degree of muscle tone during movement of the fingers compared to normal muscle tone using a 6-point scale where: 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 part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.

  • Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The MAS assessed the degree of muscle tone during movement of the thumb compared to normal muscle tone using a 6-point scale where: 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 part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.

  • Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    The MAS assessed the degree of muscle tone during movement of the thumb compared to normal muscle tone using a 6-point scale where: 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 part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.


Enrollment: 108
Study Start Date: June 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
botulinum toxin Type A
Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
Biological: botulinum toxin Type A
Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
Other Name: BOTOX®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients with upper limb spasticity following stroke who are eligible to receive botulinum toxin Type A treatment

Criteria

Inclusion Criteria:

  • Adult patients with upper limb spasticity following a stroke
  • Eligible to receive botulinum toxin Type A
  • No previous botulinum toxin Type A therapy

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01387074

Locations
Germany
Itzehoe, Schleswig-Holstein, Germany
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01387074     History of Changes
Other Study ID Numbers: MAF/AGN/NS/SPA/018
Study First Received: June 30, 2011
Results First Received: December 13, 2013
Last Updated: December 13, 2013
Health Authority: Germany: German Federal Institute for Drugs and Medicinal Devices (BfArM)

Additional relevant MeSH terms:
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014