Spasticity Registry Evaluating Epidemiology, Treatment Patterns and Clinical Needs

Muscle Spasticity Clinical Trial

— STRETCh  

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02145650
• Other study ID #: EPI-SPAS-001
• Status: Withdrawn
• Phase: N/A
• First received: May 21, 2014
• Last updated: November 2, 2015
• Start date: May 2014
• Est. completion date: August 2015

Study information

• Verified date: November 2015
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Muscle Spasticity

Intervention

Other:
• No Intervention
There is no intervention administered in this study.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator Assessment of Spasticity Severity using a 5-Point Scale		Day 1	No
Primary	Percentage of Participants with Spasticity not Receiving Treatment		Day 1	No
Primary	Spasticity Symptom Assessment Score using a 21-item Questionnaire		Day 1	No
Primary	Spasticity Impact Assessment Score using a 32-item Questionnaire		Day 1	No
Secondary	Percentage of Participants with Spasticity Receiving Treatment		Day 1	No
Secondary	Referral Patterns for Spasticity Management		Day 1	No
Secondary	Spasticity Screening Tool Score using a 13-item Questionnaire		Day 1	No