Spasticity Registry Evaluating Epidemiology, Treatment Patterns and Clinical Needs (STRETCh)

November 2, 2015 updated by: Allergan
This study will examine the epidemiology (incidence and control of a disease), burden, clinical need, and treatment patterns of spasticity in patients with a diagnosis of Cerebral Palsy (CP), Multiple Sclerosis (MS), Stroke, Spinal Cord Injury (SCI), or Traumatic Brain Injury (TBI).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a diagnosis of CP, MS, Stroke, SCI, or TBI in clinical practice evaluated for spasticity.

Description

Inclusion Criteria:

-Diagnosis of Cerebral Palsy (CP), Multiple Sclerosis (MS), Stroke, Spinal Cord Injury (SCI), or Traumatic Brain Injury (TBI) for a minimum of 3 months

Exclusion Criteria:

-Participation in a spasticity clinical trial in the past 5 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All Participants
Patients with a diagnosis of CP, MS, Stroke, SCI, or TBI will be evaluated for spasticity by their healthcare provider. Patients diagnosed with spasticity requiring treatment will be enrolled in the study. There is no intervention administered in this study.
Other: No Intervention
There is no intervention administered in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Investigator Assessment of Spasticity Severity using a 5-Point Scale
Time Frame: Day 1
Day 1
Percentage of Participants with Spasticity not Receiving Treatment
Time Frame: Day 1
Day 1
Spasticity Symptom Assessment Score using a 21-item Questionnaire
Time Frame: Day 1
Day 1
Spasticity Impact Assessment Score using a 32-item Questionnaire
Time Frame: Day 1
Day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with Spasticity Receiving Treatment
Time Frame: Day 1
Day 1
Referral Patterns for Spasticity Management
Time Frame: Day 1
Day 1
Spasticity Screening Tool Score using a 13-item Questionnaire
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

August 1, 2015

Study Registration Dates

First Submitted

May 21, 2014

First Submitted That Met QC Criteria

May 22, 2014

First Posted (Estimate)

May 23, 2014

Study Record Updates

Last Update Posted (Estimate)

November 3, 2015

Last Update Submitted That Met QC Criteria

November 2, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPI-SPAS-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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