NCT02145650

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

November 3, 2015

Status Verified

November 1, 2015

Enrollment Period

1.3 years

First QC Date

May 21, 2014

Last Update Submit

November 2, 2015

Conditions

Muscle Spasticity

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • 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

Study Arms (1)

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

Interventions

No InterventionOTHER

There is no intervention administered in this study.

All Participants

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Toms River, New Jersey, United States

Location

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2014

First Posted

May 23, 2014

Study Start

May 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

November 3, 2015

Record last verified: 2015-11

Locations

US(1)