Can extended treatment with N-pep-12 improve recovery after acute ischemic stroke?

Phase 4

• Conditions: Supratentorial, radiologically confirmed ischemic stroke with the onset 30-120 days prior to screening; Circulatory System; Stroke, not specified as haemorrhage or infarction

• Registration Number: ISRCTN15764675
• Lead Sponsor: The Foundation for the Study of Neuroscience and Neuroregeneration (Fundatia pentru Studiul Nanoneurostiintelor si Neuroregenerarii)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-29
• Last Update Posted: 30 October 2023
• Study Completion: 2023-10-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 107

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified