Multiple Sclerosis Clinical Trial
Official title:
A Prospective, Open Label, Single Center Study of Patients With Multiple Sclerosis With Lower Extremity Spasticity Who Are Treated With Dysport
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.
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
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05528666 -
Risk Perception in Multiple Sclerosis
|
||
| Completed |
NCT03608527 -
Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis
|
N/A | |
| Recruiting |
NCT05532943 -
Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis
|
Phase 1/Phase 2 | |
| Completed |
NCT02486640 -
Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
|
||
| Completed |
NCT01324232 -
Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis
|
Phase 2 | |
| Completed |
NCT04546698 -
5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
|
||
| Active, not recruiting |
NCT04380220 -
Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
|
||
| Completed |
NCT02835677 -
Integrating Caregiver Support Into MS Care
|
N/A | |
| Completed |
NCT03686826 -
Feasibility and Reliability of Multimodal Evoked Potentials
|
||
| Recruiting |
NCT05964829 -
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
|
N/A | |
| Withdrawn |
NCT06021561 -
Orofacial Pain in Multiple Sclerosis
|
||
| Completed |
NCT03653585 -
Cortical Lesions in Patients With Multiple Sclerosis
|
||
| Recruiting |
NCT04798651 -
Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis
|
N/A | |
| Active, not recruiting |
NCT05054140 -
Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis
|
Phase 2 | |
| Completed |
NCT05447143 -
Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis
|
N/A | |
| Recruiting |
NCT06195644 -
Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients
|
Phase 1 | |
| Completed |
NCT04147052 -
iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis
|
N/A | |
| Completed |
NCT03591809 -
Combined Exercise Training in Patients With Multiple Sclerosis
|
N/A | |
| Completed |
NCT03594357 -
Cognitive Functions in Patients With Multiple Sclerosis
|
||
| Completed |
NCT03269175 -
BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies
|
Phase 4 |