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Retrospective Study of Patients With Spasticity in the Spanish Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01383681
Recruitment Status : Completed
First Posted : June 28, 2011
Results First Posted : November 14, 2013
Last Update Posted : November 14, 2013
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
This is a retrospective study of patients with spasticity in the Spanish population.

Condition or disease Intervention/treatment
Muscle Spasticity Other: No treatment

Study Design
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Study Type : Observational
Actual Enrollment : 235 participants
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
Study Start Date : February 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012
Groups and Cohorts
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Group/Cohort Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Physician Assessment of Spasticity [ Time Frame: Baseline ]
    The physician assessed spasticity as per local standard practice. Not enough data was collected for analysis of this outcome measure.

  2. Physician Assessment of Spasticity [ Time Frame: Month 12 ]
    The physician assessed spasticity as per local standard practice. Not enough data was collected for analysis of this outcome measure.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01383681


Locations
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Spain
Mataro, Barcelona, Spain
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01383681    
Other Study ID Numbers: MAF/AGN/NS/SPA/019
First Posted: June 28, 2011    Key Record Dates
Results First Posted: November 14, 2013
Last Update Posted: November 14, 2013
Last Verified: September 2013
Additional relevant MeSH terms:
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Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
 Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases