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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014