Comprehensive Reparative Therapy in Ischemic Stroke COMplex Repair in

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02581371
Study type	Interventional
Source	Clinical Institute of the Brain, Russia
Contact	Andrey Avgustovich Belkin, Prof.,MD,PhD
Phone	(343) 311-3381
Email	clinic@neuro-clinic.ru
Status	Recruiting
Phase	Phase 4
Start date	February 2015
Completion date	February 2017

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms