A Prospective Study of Spasticity in Individuals With Mul... | NCT01111435

Studies
A Prospective Study of Spasticity in Individuals With Multiple Sclerosis

NCT01111435

Sponsor

Fraser, Cira, Ph.D., RN, ACNS-BC

Status

Unknown status

Last Update Posted

Mar 5, 2012Estimated

Enrollment

110Estimated

Phase

Not provided

Conditions

Spasticity

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Sep 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Apr 26, 2010

First Submission Date that Met QC Criteria

Apr 26, 2010

First Posted Date

Apr 27, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2012

Last Update Posted Date

Mar 5, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Cira Fraser PhD, RN, ACNS-BC, Associate Professor, Fraser, Cira, Ph.D., RN, ACNS-BCPrincipal Investigator

Lead Sponsor

Fraser, Cira, Ph.D., RN, ACNS-BCINDIV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is expected to contribute to the body of knowledge on the benefits of individuals with MS taking glatiramer acetate (Copaxone®). If patients have less spasticity when taking glatiramer acetate (Copaxone®), they may be more likely to have an improved quality of life.

The hypotheses for this study are:

Study participants who transition from interferon therapy to glatiramer acetate (Copaxone®) for a six month period will have a decrease in spasticity.
Study participants who transition from interferon therapy to glatiramer acetate (Copaxone®) for a six month period will have a change in perceptions of the impact of spasticity on their lives.

Detailed Description

The purpose of this study is to determine if there is a change in spasticity and perceptions of the impact of spasticity in individuals with multiple sclerosis who transition from interferon to glatiramer acetate (Copaxone®).•

Potential participants meeting the criteria will be identified by Shared Solutions and informed of the study. Interested individuals will contact the investigator either by email or telephone. Enrollment will continue until there are 110 participants starting glatiramer acetate (Copaxone®).
Potential participants will be informed of the details of the study, eligibility will be confirmed, and participant's questions answered.
The two study instruments and the sociodemographic questionnaire will be emailed or mailed via UPS along with an information letter. May be returned either via email, fax or UPS mail.
At month 6 for each participant, the study instruments and sociodemographic questionnaire will be sent a second time and returned to the investigator.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

110Estimated

Label	Type	Description	Intervention Names
Individuals with Multiple Sclerosis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Multiple Sclerosis Spasticity Scale		Administered at 6 month follow-up

Secondary Outcomes

Measure	Description	Time Frame
Performance Scales (Measure of Disability)		Administered at 6 month follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Stopped interferon (beta-1a or beta-1b) within the past 30 days
About to start or started glatiramer acetate (Copaxone®) within the past 21 days.
At least 18 years of age
Has spasticity at the beginning of the study
Able to ambulate with unilateral support or without support
Understands, speaks and reads English

Exclusion Criteria:

Severe Gait Disability or Total Gait Disability

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Individuals with Multiple Sclerosis living in the community

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cira Fraser, PHD	Monmouth University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shared Solutions Call Center		Kansas City	Missouri	64131	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	Meca-Lallana, J.E., Amorin-Diaz, M., Martinez-Navarro, M.L. & Fernandez- Barreiro, A. (2008). Spasticity in multiple sclerosis: A pilot study to evaluate the efficacy of glatiramer acetate. Multiple Sclerosis, 145 (Suppl. 2), S165.

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D009122	Muscle Hypertonia
D020879	Neuromuscular Manifestations