Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06437626
Status:
COMPLETED
Last Update Posted:
2024-05-31
First Post:
2024-05-24
Brief Title:
The Study of Efficacy and Safety of Mexidol in Stroke Therapy MIR
Sponsor:
Pharmasoft
Organization:
Pharmasoft
Study Overview
Official Title:
Prospective International Multicenter Randomized Double-blind Placebo-controlled Parallel-group Study of the Efficacy and Safety of Mexidol in Sequential Treatment of Patients in the Acute and Early Recovery Periods of Ischemic Stroke
Status:
COMPLETED
Status Verified Date:
2024-09
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:
MIR
Brief Summary:
The main purpose of the clinical trial is to assess efficacy and safety of Mexidol in sequential treatment solution for intravenous and intramuscular administration 50 mgml film-coated tablets 250 mg of patients in the acute and early recovery periods of ischemic stroke
Detailed Description:
As the main purpose of the clinical study is to evaluate safety and efficacy of a neuroprotector Mexidol it was crucial to develop strict protocol requirements that would help to avoid the challenges of estimation of neuroprotective effect for stroke therapy The current treatment options for stroke are still limited and do not take into account rehabilitation period and patients further quality of life
As per protocol requirements 313 participants were screened 304 participants met all comprehensive eligibility criteria 24 participants dropped out during the clinical trial period The Modified Rankin Scale mRS was selected as the most representative primary outcome measuring tool due to the adequate representation of functional outcome Additionally the neuroprotective efficacy of Mexidol was assessed for its ability to reduce stroke-related neurologic deficit and mood disorder symptoms cognitive impairment and to improve mobility after stroke
As per protocol requirements 313 participants were screened 304 participants met all comprehensive eligibility criteria 24 participants dropped out during the clinical trial period The Modified Rankin Scale mRS was selected as the most representative primary outcome measuring tool due to the adequate representation of functional outcome Additionally the neuroprotective efficacy of Mexidol was assessed for its ability to reduce stroke-related neurologic deficit and mood disorder symptoms cognitive impairment and to improve mobility after stroke
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PHS-APIS-004-MEX-SOL-TAB | OTHER | Ministry of Health Russian Federation | None |