Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 9:03 PM
Study NCT ID:
NCT07482618
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Spasticity, Neuropathic Pain, and Gait Analysis in Stroke Patients Receiving Tolperison Therapy After Botulinum Toxin Injection
Sponsor:
Ayse Guc
Organization:
Study Overview
Official Title:
Evaluation of Spasticity, Neuropathic Pain, and Gait Analysis in Stroke Patients Receiving Tolperison Therapy After Botulinum Toxin Injection: A Controlled Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
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:
Tolperison is an antispastic agent used in the treatment of spasticity. Studies on tolperison are limited, and the literature on its effectiveness against spasticity and neuropathic pain is also limited.
Detailed Description:
Botulinum toxin injection is the most commonly used antispastic agent in the treatment of regional spasticity in hemiplegia patients. Both botulinum toxin injections and oral antispastic agents are widely used. Many studies have shown that botulinum toxin injection is more effective in treating regional spasticity. Because botulinum toxin injection is more frequently preferred, the study included patients who received botulinum toxin injections. Patients receiving botulinum toxin injections benefit from the injection, but in some patients, the injection is insufficient. Additionally, oral antispastic agents such as baclofen, tizanidine, and tolperisone are also added to the treatment. Reimbursement for tolperisone for hemiplegia patients has recently begun. It is covered by the Social Security Institution (SGK), but it is not a widely used drug. The researcher will screen patients diagnosed with hemiplegia who have been initiated with daily botulinum toxin injections (+/- tolperison). Patients will be followed prospectively. Patients prescribed tolperison will be examined before receiving the medication, and post-treatment follow-ups will be evaluated using questionnaires. The aim was to observe whether tolperison makes a difference between the groups. Patients in the botulinum toxin injection group will be followed before and after the injection. The aim of this study is to examine the effectiveness of tolperison in antispasticity and neuropathic pain.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: