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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: April 17, 2013
Last verified: April 2013
History of Changes
  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:

MedlinePlus related topics: Botox
U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Muscle Tone as Measured by the Modified Ashworth Scale (MAS) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 112
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
Patients will receive 1 treatment of botulinum toxin Type A at a dose determined by their physician at Baseline. Patients may receive a second treatment of botulinum toxin Type A approximately 12 weeks late.
 Biological: botulinum toxin Type A
Patients will receive 1 treatment of botulinum toxin Type A at a dose determined by their physician at Baseline. Patients may receive a second treatment of botulinum toxin Type A approximately 12 weeks later.
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
Last Updated: April 17, 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 June 18, 2013