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Clinical Trials/ISRCTN15764675
ISRCTN15764675
Active, Not Recruiting
Phase 4

Combined neuropsychological, neurophysiological and psychophysiological assessment of the effects of N-Pep-12 on neurorecovery in patients after ischemic stroke - N-Pep-12 Extension

The Foundation for the Study of Neuroscience and Neuroregeneration (Fundatia pentru Studiul Nanoneurostiintelor si Neuroregenerarii)0 sites107 target enrollmentApril 29, 2020
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Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
The Foundation for the Study of Neuroscience and Neuroregeneration (Fundatia pentru Studiul Nanoneurostiintelor si Neuroregenerarii)
Enrollment
107
Status
Active, Not Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 29, 2020
End Date
October 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
The Foundation for the Study of Neuroscience and Neuroregeneration (Fundatia pentru Studiul Nanoneurostiintelor si Neuroregenerarii)

Eligibility Criteria

Inclusion Criteria

  • •1\. Stroke onset 30\-120 days prior to screening
  • •2\. Stroke is ischemic in origin, supratentorial, and radiologically confirmed (CT or MRI)
  • •3\. No significant pre\-stroke disability (pre\-stroke Modified Rankin Score of 0 or 1\)
  • •4\. Goodglass and Kaplan Communication Scale Score of \> 2 at screening
  • •5\. No other radiologically confirmed stroke in the 3 months preceding index stroke
  • •6\. Age between 18 and 80 years, inclusive
  • •7\. Signed informed consent form

Exclusion Criteria

  • •1\. Pre\-existing and active major neurological disease
  • •2\. Pre\-existing and active (e.g., on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease, or dementia (the short Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) score \>3\)
  • •3\. Advanced liver, kidney, cardiac, or pulmonary disease
  • •4\. A terminal medical diagnosis consistent with survival \< 1 year
  • •5\. Major drug dependency, including alcohol (in the investigator’s judgment)
  • •6\. Injury of writing hand influencing cognitive or other outcome measures, in the investigator’s judgment
  • •7\. Females who are pregnant or lactating

Outcomes

Primary Outcomes

Not specified

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