Condition category
Circulatory System
Date applied
11/02/2019
Date assigned
19/02/2019
Last edited
19/02/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Impairment of mental (cognitive) processing is a common finding in patients with stroke, regardless of severity, and it has an important impact on quality of life. This is a pilot study to investigate the effects of N-Pep-12 treatment on the recovery of patients with post-stroke cognitive impairment. N-Pep-12 is a proprietary, peptide-based nutritional supplement that has been shown to exert neuroprotective and pro-cognitive effects in experimental studies as well as in earlier clinical studies in patients suffering from age-related cognitive deficits.

Who can participate?
Adults between 18 and 80 years with supratentorial ischemic stroke onset 30-120 days prior to screening.

What does the study involve?
Participants are invited to join this study at 30-120 days post stroke onset. After informing patients about study procedures, benefits and potential risks, they sign a consent form. All participants included in the study must pass the screening criteria and baseline evaluations. Individuals are then allocated to one of two groups. The first group is administered N-Pep-12 (90 mg) capsules, once per day, oral, for 90 days, while the second group doesn't get any treatment.

What are the possible benefits and risks of participating?
Potential benefit of N-Pep-12 administration is the improved cognitive function and brain recovery in patients with post-stroke cognitive impairment. The main risk for patients is developing adverse events (AE). Their severity and the causality to study medication is carefully assessed in order to establish a detailed safety profile of the intervention.

Where is the study run from?
The N-PEP-12 is a single centre trial run from Cluj-Napoca, Romania.

When has the study started and how long is it expected to run for?
April 2016 to April 2019

Who is funding the study?
The Society for the Study of Neuroprotection and Neuroplasticity (SSNN) (Romania)

Who is the main contact?
1. Prof. Dr. Dafin Fior Muresanu, dafinm@ssnn.ro
2. Stefan Strilciuc, MPH, stefan.strilciuc@ssnn.ro

Trial website

Contact information

Type

Scientific

Primary contact

Prof Dafin Muresanu

ORCID ID

http://orcid.org/0000-0002-9536-1153

Contact details

No. 37 Mircea Eliade Street
Cluj-Napoca
400364
Romania
+40740066761
dafinm@ssnn.ro

Type

Public

Additional contact

Mr Stefan Strilciuc

ORCID ID

http://orcid.org/0000-0001-6112-0223

Contact details

No. 37 Mircea Eliade street
Cluj-Napoca
400364
Romania
+40740066761
stefan.strilciuc@ssnn.ro

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Combined Neuropsychological, Neurophysiological and Psychophysiological Assessment of the Effects of N-Pep-12 on Neurorecovery in Patients after Ischemic Stroke

Acronym

N-Pep-12

Study hypothesis

The study assesses the therapeutic effect and the safety of a single daily dose of 90 mg of N-Pep-12 in supporting neurorecovery in comparison to a control group of patients after stroke

Ethics approval

Approved 10/12/2015, Ethics Committee of the Iuliu Hatieganu University of Medicine and Pharmacy (8 Babeş Street, 400012 Cluj-Napoca, Romania; +40-264-597-256; contact@umfcluj.ro), ref: 507/10.12.2015. Amended twice refs: 82/24.03.2016;104/12.02.2018

Study design

Exploratory, prospective, randomized, single-blinded, controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Supratentorial, radiologically confirmed ischemic stroke with the onset 30-120 days prior to screening

Intervention

The synopsis of the study is organised in 3 visits:
Visit 1 – Screening / Baseline
Visit 2 – Efficacy / Safety - Day 30
Visit 3 – Efficacy / Safety - Day 90

No follow-up was performed after the 90-day evaluation. The study arms were administered the following treatment courses:
1. Treatment Group:
N-Pep-12 (90 mg) capsules 1/ day oral for 90 days
2. Reference Group

Randomisation, Blinding and Unblinding
This is a single-blinded study. Communication is forbidden between assessments and the person who gives the treatment.
Patients meeting the inclusion and exclusion criteria will be randomly assigned to receive either active treatment or control treatment based on the time of their enrollment in the study. Randomisation was performed 2:1 (2 -intervention, 1 -placebo). The first two patients enrolled will receive active treatment, the third patient will receive placebo. This allocation scheme shall be continued until 120 patients have been enrolled.

Intervention type

Drug

Phase

Phase IV

Drug names

N-PEP-12

Primary outcome measure

1. Cognitive function assessed using Montreal Cognitive Assessment (MoCA) (Nasreddine, 2005) at days 0, 30, 90
2. Emotional status assessed using Hospital Anxiety and Depression Scale (Zigmond, 1983) at days 0, 30, 90
3. Cognitive function assessed using Digit Span (Wechsler adult intelligence scale – third edition (Wechsler, 1997) at days 0, 30, 90
4. Cognitive function assessed using Color Trails Test (Posch, 2005) at days 0, 30, 90
5. Cognitive function assessed using PSI (Processing Speed Index, Wechsler adult intelligence scale – third edition) at days 0, 30, 90

Secondary outcome measures

1. Eye movements assessed using a Tobii Pro TX300 eye tracking device and analyzed using Tobii Studio software at 30, 101 and 180 days.
2. Brain electrical activity assessed using electoencephalography (EEG) and analyzed quantitatively using BrainAnalyzer software at 30, 101 and 180 days.

Overall trial start date

01/09/2015

Overall trial end date

30/04/2019

Reason abandoned (if study stopped)

Eligibility

Participant 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 stroke in the 3 months preceding index stroke
6. Age between 18 and 80 years, inclusive

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant 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.
8. Hemianopsia
9. Neglect
10. Myopia >3
11. Glaucoma

Recruitment start date

05/04/2016

Recruitment end date

30/04/2019

Locations

Countries of recruitment

Romania

Trial participating centre

RoNeuro Institute for Neurological Research and Diagnostic
No. 37 Mircea Eliade Street
Cluj-Napoca
400364
Romania

Sponsor information

Organisation

EN: The foundation for the study of neuroscience and neuroregeneration (RO: Fundatia pentru Studiul Nanoneurostiintelor si Neuroregenerarii)

Sponsor details

No. 37 Mircea Eliade Street
Cluj-Napoca
400364
Romania
+40740150076
office@ssnn.ro

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

EN: The foundation for the study of neuroscience and neuroregeneration (RO: Fundatia pentru Studiul Nanoneurostiintelor si Neuroregenerarii)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

31/12/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes