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
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: 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 August 28, 2014