Stroke Clinical Trial
Official title:
Phase 2/3 Adaptive Design, Randomized Double-blind Placebo-controlled Study to Evaluate the Safety and Efficacy of DM199 for the Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)
This is a Phase 2/3 study evaluating the safety and efficacy of DM199 in treating participants presenting within 24 hours of Acute Ischemic Stroke (AIS) onset for whom fibrinolytics and/or a catheter-based procedure, mechanical thrombectomy (MT), are not medically appropriate or available due to constraints of clot location, comorbidity risks, and/or time from estimated onset of stroke. The double-blinded study will be randomized, placebo controlled at up to approximately 100 sites.
This is a randomized, double-blind, placebo-controlled Phase 2/3 adaptive, multi-center study to evaluate the safety and efficacy of DM199 for the treatment of acute ischemic stroke. Participants with AIS will be randomized 1:1 to DM199 or placebo (placebo is normal saline given with the same route (IV or SC), volume and frequency as DM199), administered as a single intravenous (IV) dose followed by a subcutaneous (SC) dose within 2-12 hours of IV dose completion and then 2 times per week for three weeks (until Day 21). After dosing is complete, participants will be followed up by the investigator at approximately 30 and 90 days after their first dose. A formal interim analysis will be conducted after 144 participants complete their Day 90 assessment in Part A. The purposes of this interim analysis are to assess safety, allow early stopping of the study for futility, or continuing the study with a revised final sample size of between 240 up to 728. The futility rule will be non-binding. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
| Recruiting |
NCT03869138 -
Alternative Therapies for Improving Physical Function in Individuals With Stroke
|
N/A | |
| Completed |
NCT04101695 -
Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects
|
N/A | |
| Completed |
NCT04034069 -
Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
|
N/A | |
| Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
| Completed |
NCT00391378 -
Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
|
N/A | |
| Recruiting |
NCT06204744 -
Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial
|
N/A | |
| Active, not recruiting |
NCT06043167 -
Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
|
||
| Active, not recruiting |
NCT04535479 -
Dry Needling for Spasticity in Stroke
|
N/A | |
| Completed |
NCT03985761 -
Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke
|
N/A | |
| Recruiting |
NCT00859885 -
International PFO Consortium
|
N/A | |
| Recruiting |
NCT06034119 -
Effects of Voluntary Adjustments During Walking in Participants Post-stroke
|
N/A | |
| Completed |
NCT03622411 -
Tablet-based Aphasia Therapy in the Chronic Phase
|
N/A | |
| Completed |
NCT01662960 -
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
|
N/A | |
| Recruiting |
NCT05854485 -
Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
|
N/A | |
| Active, not recruiting |
NCT05520528 -
Impact of Group Participation on Adults With Aphasia
|
N/A | |
| Completed |
NCT03366129 -
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
|
||
| Completed |
NCT05805748 -
Serious Game Therapy in Neglect Patients
|
N/A | |
| Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
| Recruiting |
NCT05993221 -
Deconstructing Post Stroke Hemiparesis
|