NCT01383681

Brief Summary

This is a retrospective study of patients with spasticity in the Spanish population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
235

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 14, 2013

Completed
Last Updated

November 14, 2013

Status Verified

September 1, 2013

Enrollment Period

1.7 years

First QC Date

June 27, 2011

Results QC Date

September 9, 2013

Last Update Submit

September 9, 2013

Conditions

Outcome Measures

Primary Outcomes (2)

  • Physician Assessment of Spasticity

    The physician assessed spasticity as per local standard practice. Not enough data was collected for analysis of this outcome measure.

    Baseline

  • Physician Assessment of Spasticity

    The physician assessed spasticity as per local standard practice. Not enough data was collected for analysis of this outcome measure.

    Month 12

Study Arms (1)

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

Interventions

There was no treatment in this study.

All Participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with diagnosis of spasticity are selected from rehabilitation departments within the Spanish health system.

You may qualify if:

  • Diagnosis of spasticity

You may not qualify if:

  • Current enrollment in a clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Mataró, Barcelona, Spain

Location

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Not enough data was collected for analysis of Physician's Assessment of Spasticity outcome measures.

Results Point of Contact

Title
Vice President Medical Affairs,
Organization
Allergan, Inc

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

June 27, 2011

First Posted

June 28, 2011

Study Start

February 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

November 14, 2013

Results First Posted

November 14, 2013

Record last verified: 2013-09

Locations