Can treatment with N-PEP-12 improve recovery after acute ischemic stroke?
| ISRCTN | ISRCTN10702895 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10702895 |
- Submission date
- 11/02/2019
- Registration date
- 19/02/2019
- Last edited
- 28/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
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 September 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
Contact information
Scientific
No. 37 Mircea Eliade Street
Cluj-Napoca
400364
Romania
 ORCID ID |
0000-0002-9536-1153 |
|---|---|
| Phone | +40740066761 |
| dafinm@ssnn.ro |
Public
No. 37 Mircea Eliade street
Cluj-Napoca
400364
Romania
| ORCID ID |
0000-0001-6112-0223 |
|---|---|
| Phone | +40740066761 |
| stefan.strilciuc@ssnn.ro |
Study information
| Study design | Exploratory, prospective, randomized, single-blinded, controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Combined Neuropsychological, Neurophysiological and Psychophysiological Assessment of the Effects of N-Pep-12 on Neurorecovery in Patients after Ischemic Stroke |
| Study 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(s) | 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 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | 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 | Current secondary outcome measures as of 02/04/2020: 1. Eye movements assessed using a Tobii Pro TX300 eye tracking device and analyzed using Tobii Studio software at days 0, 30, 90 2. Brain electrical activity assessed using electoencephalography (EEG) and analyzed quantitatively using BrainAnalyzer software at days 0, 30, 90 _____ Previous 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 study start date | 01/09/2015 |
| Overall study end date | 26/10/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 |
| Total final enrolment | 121 |
| 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 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 | 26/07/2019 |
Locations
Countries of recruitment
- Romania
Study participating centre
Cluj-Napoca
400364
Romania
Sponsor information
Research organisation
No. 37 Mircea Eliade Street
Cluj-Napoca
400364
Romania
| Phone | +40740150076 |
|---|---|
| office@ssnn.ro |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 31/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 02/10/2020 | 02/12/2020 | Yes | No |
| Results article | 01/06/2021 | 28/06/2021 | Yes | No | |
| Other publications | Correlating Eye-Tracking Fixation Metrics and Neuropsychological Assessment after Ischemic Stroke | 25/07/2023 | 05/03/2024 | Yes | No |
| Protocol file | version 2.0 | 17/01/2018 | 28/06/2024 | No | No |
Additional files
Editorial Notes
28/06/2024: Uploaded protocol (not peer-reviewed) as an additional file.
05/03/2024: Publication reference added.
28/06/2021: Publication reference added.
02/12/2020: Publication reference added.
02/04/2020: The secondary outcome measures were changed.
30/07/2019: The following changes were made to the trial record:
1. The overall end date was changed from 03/09/2019 to 26/10/2019.
2. The recruitment end date was changed from 30/06/2019 to 26/07/2019.
3. The total final enrolment was added.
17/05/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/04/2019 to 30/06/2019.
2. The overall trial end date was changed from 30/04/2019 to 03/09/2019.
