Retrospective Study of Patients With Spasticity in the Spanish Population

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01383681
First received: June 27, 2011
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

This is a retrospective study of patients with spasticity in the Spanish population.


Condition Intervention
Muscle Spasticity
Other: No treatment

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Observational Study To Establish The Methodology Used In The Evaluation, Treatment And Assessment Of Progression Of Spasticity In The Spanish Population

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Physician Assessment of Spasticity [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The physician assessed spasticity as per local standard practice. Not enough data was collected for analysis of this outcome measure.

  • Physician Assessment of Spasticity [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    The physician assessed spasticity as per local standard practice. Not enough data was collected for analysis of this outcome measure.


Enrollment: 235
Study Start Date: February 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
All Participants
This was a retrospective chart review in patients with spasticity in the Spanish population. There was no treatment in this study.
Other: No treatment
There was no treatment in this study.

  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

Patients with diagnosis of spasticity are selected from rehabilitation departments within the Spanish health system.

Criteria

Inclusion Criteria:

  • Diagnosis of spasticity

Exclusion Criteria:

  • Current enrollment in a clinical trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01383681

Locations
Spain
Mataro, Barcelona, Spain
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01383681     History of Changes
Other Study ID Numbers: MAF/AGN/NS/SPA/019
Study First Received: June 27, 2011
Results First Received: September 9, 2013
Last Updated: September 9, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014