Trial · Interventional
Status unknownPhase 4Registry dataComprehensive Reparative Therapy in Ischemic Stroke COMplex Repair in Ischemic Stroke-Arm
Overview
- Status
- Status unknown
- Phase
- Phase 4
- Enrollment
- 30 participants (estimated)
- Sponsor
- Clinical Institute of the Brain, Russia · Other
- Design
- Randomized · Double masking
- Countries
1 country
Russia
- Start
- Feb 2015
- Primary completion
- Feb 2017 (estimated)
- Completion
- Feb 2017 (estimated)
- First posted
- 21 Oct 2015 (estimated)
- Last update posted
- 21 Oct 2015 (estimated)
- Conditions
- Ischemic Stroke
Timeline
1 trial
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
Comprehensive Reparative Therapy in Ischemic Stroke COMplex Repair in Ischemic Stroke-Arm
NCT02581371Feb 2015 to est. Feb 2017
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Cerebrolysin infusionDrug
- Placebo infusionOther
Arms2
Experimental
Cerebrolysin infusion
Cerebrolysin, solution for injection, 10 ml vials. 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
Placebo comparator
Placebo infusion
Sodium chloride 0.9%, solution for infusion, 100 ml. Two 10-day courses of 100 ml of sodium chloride 0.9% iv slowly drip daily, separated with a 7-day interval.
Primary outcomes1
Outcomes the sponsor listed as primary.
Overall dynamics of the hand function assessed by the Frenchay Arm Test
Time frame · 6 months
Registry description
Visit 5 data comparison with Visit 0 data
Secondary outcomes(10)
Dynamics of the hand function assessed by the Frenchay Arm Test
Time frame · 6 months
Registry description
Visits 2,3,4 data comparison with Visit 0 data
Dynamics of the grades on the NIHSS scale
Time frame · 6 months
Registry description
Visits 2,3,4,5 data comparison with Visit 0 data
Dynamics of the grades on the modified Rankin scale
Time frame · 6 months
Registry description
Visits 2,3,4,5 data comparison with Visit 0 data
Dynamics of the Barthel index changes
Time frame · 6 months
Registry description
Visits 2,3,4,5 data comparison with Visit 0 data
Dynamics of the cerebral infarction volume decrease according the 3D MRI data
Time frame · 6 months
Dynamics of the hemispheres cortex topology of palms motor centers according to navigated transcranial stimulation of the brain (NBS)
Time frame · 6 months
Registry description
Visit 4, 5 data comparison with Visit 3 data
Dynamics of motor response threshold based on the results of navigated transcranial stimulation of the brain (NBS)
Time frame · 6 months
Dynamics of the amplitude of motor responses
Time frame · 6 months
Dynamics of the latency of motor responses
Time frame · 6 months
Frequency, nature and severity of adverse events.
Time frame · 6 months
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 45 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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