Spasticity Registry Evaluating Epidemiology, Treatment Patterns and Clinical Needs

Withdrawn

• Conditions: Muscle Spasticity

• Registration Number: NCT02145650
• Lead Sponsor: Allergan

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-05-22
• Study First Posted: 2014-05-23
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants with Spasticity Receiving Treatment	Day 1
Referral Patterns for Spasticity Management	Day 1
Spasticity Screening Tool Score using a 13-item Questionnaire	Day 1