NCT02581371

Comprehensive Reparative Therapy in Ischemic Stroke COMplex Repair in Ischemic Stroke-Arm

Randomized, Double-blind, Placebo-controlled Study of the Effect of Cerebrolysin® (EVER Neuro Pharma GmbH, Austria) at the Level of Paresis of the Upper Limb When Used in Complex Therapy of Acute Ischemic Stroke

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Clinical Institute of the Brain, Russia · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of the present clinical phase IV study is to estimate the influence of Cerebrolysin in combination with standard therapy on the dynamics of recovery of the paretic upper limb in patients with acute ischemic stroke. Each patient participates in the study for 176-190 days (approximately 6 months). The estimated duration of the study is 2 years.

Detailed description

Rehabilitation programs and drug therapy in a stroke aimed, primarily, to the stimulation of the processes of neuroplasticity. After the screening procedures the eligible patients get randomized in 1 of the 2 groups: either the group of a standard therapy in combination with Cerebrolysin infusions, or the group of a standard therapy in combination with placebo infusions. The therapy consists of the 3 consecutive periods: 1. st - 10 days of daily infusions of Cerebrolysin / placebo; 2. nd - 7 days break; 3. d - 10 days of daily infusions of Cerebrolysin / placebo. All participants will attend 7 Visits of the study (Visits 0, 1-6) at 2 sites respectively: 1. st - clinical center #1 - Sverdlovsk Regional Clinical Hospital #1, Ekaterinburg 2. nd - clinical center #2 - Clinical Institute of Brain, Ekaterinburg. Patients will be transferred from the 1st site to the 2nd one at the moment of time between Visit 2 and Visit 3. Patients will undergo traditional laboratory and clinical examination procedures and several specific ones such as scale NIHSS, modified Rankin scale, Barthel index, hand Frenchy assessments. All hand Frenchy assessments will be videotaped for later evaluation by an authorized researcher. All participants will undergo the procedure of navigational transcranial magnetic stimulation of the brain NBS eXimia Nexstim with the use of an individual 3D brain model created on the Visit 0 MRI results basis. Neither the patient nor the doctor will know whether they receive an investigational drug or placebo.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Cerebrolysin infusion	Two 10-day courses of 50 ml of investigational drug + 50 ml of sodium chloride 0.9% iv slowly drip infusions daily, separated with a 7-day interval
OTHER	Placebo infusion	Two 10-day courses of 100 ml of sodium chloride 0.9% iv slowly drip daily, separated with a 7-day interval

Timeline

• Start date: 2015-02-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2015-10-21
• Last updated: 2015-10-21

Locations

2 sites across 1 country: Russia