Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT03585569
Status:
UNKNOWN
Last Update Posted:
2018-07-13
First Post:
2018-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
" Treating MS Patients With Lower Extremity Spasticity Using Dysport"
Sponsor:
Neurology Center of New England P.C.
Organization:
Study Overview
Official Title:
A Prospective, Open Label, Single Center Study of Patients With Multiple Sclerosis With Lower Extremity Spasticity Who Are Treated With Dysport
Status:
UNKNOWN
Status Verified Date:
2018-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether Dysport® (abobotulinumtoxinA) injections for lower extremity spasticity showed a significant reduction of lower extremity spasticity after being injected with Dysport® (abobotulinumtoxinA) in patients with MS.
Detailed Description:
Primary Objective To evaluate the effect of Dysport® (abobotulinumtoxin A) on lower extremity spasticity (soleus, gastrocnemius, lateral gastrocnemius, medial gastrocnemius, flexor digitorum longus, flexor halluces longus, rectus femorus, vastus lateralis, lateral hamstrings, medial hamstrings, adductor magnus, adductor longus, adductor brevis, triceps surae, tibialis posterior or anterior tibialis).
Other Objectives
* To explore the effect of Dysport® on improvement in walking ability in patients with MS
* To explore the effect of Dysport® on quality of (QoL) in patients with MS. Primary Endpoint Absolute change from baseline in Modified Ashworth Scale (MAS) through 20 weeks of treatment.
Other Endpoints
* Change from baseline in MAS scores at Weeks 12, 16, and 20.
* Change from baseline on QoL based on patient reported outcome (PRO) measures on the MSWS-12, MSIS 29, pain scales (0-10 pain scale) the MSSS-88, and the Penn spasm frequency scale through 20 weeks of treatment.
* Change from baseline on the time 25 foot walk (T25FW) test with timed up and go (TUG) through 20 weeks of treatment.
* Change from baseline on expanded disability status scale (EDSS) score at Weeks 12, 16, 20.
* Change from baseline in speed, cadence, general symmetry, propulsion, stride length, T25FW, TUG using GWALK device for gait assessments through 20 weeks.
* Adverse events over 20 weeks
* Serious adverse events over 20 weeks
Other Objectives
* To explore the effect of Dysport® on improvement in walking ability in patients with MS
* To explore the effect of Dysport® on quality of (QoL) in patients with MS. Primary Endpoint Absolute change from baseline in Modified Ashworth Scale (MAS) through 20 weeks of treatment.
Other Endpoints
* Change from baseline in MAS scores at Weeks 12, 16, and 20.
* Change from baseline on QoL based on patient reported outcome (PRO) measures on the MSWS-12, MSIS 29, pain scales (0-10 pain scale) the MSSS-88, and the Penn spasm frequency scale through 20 weeks of treatment.
* Change from baseline on the time 25 foot walk (T25FW) test with timed up and go (TUG) through 20 weeks of treatment.
* Change from baseline on expanded disability status scale (EDSS) score at Weeks 12, 16, 20.
* Change from baseline in speed, cadence, general symmetry, propulsion, stride length, T25FW, TUG using GWALK device for gait assessments through 20 weeks.
* Adverse events over 20 weeks
* Serious adverse events over 20 weeks
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: