Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
12
Countries
1
Sites
1
N/A submitted trial is conducted on healthy subjects
Key facts
- Sponsor
- Pikralida Sp. z o.o.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 13 Oct 2023 → 21 Dec 2023
- Decision date (initial)
- 2023-10-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
N/A submitted trial is conducted on healthy subjects
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10036312 | Post-traumatic epilepsy | 100000004852 |
| 22.1 | PT | 10076982 | Post stroke epilepsy | 100000004852 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pikralida Sp. z o.o.
- Sponsor organisation
- Pikralida Sp. z o.o.
- Address
- Ul. Uniwersytetu Poznanskiego 10
- City
- Poznan
- Postcode
- 61-614
- Country
- Poland
Scientific contact point
- Organisation
- Pikralida Sp. z o.o.
- Contact name
- Stanislaw Pikul
Public contact point
- Organisation
- Pikralida Sp. z o.o.
- Contact name
- Stanislaw Pikul
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 12 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Czechia | 2023-10-13 | 2023-12-21 | 2023-10-13 | 2023-11-30 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-26 | Czechia | Acceptable 2023-10-12
|
2023-10-12 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-10-12 | Czechia | Acceptable 2023-10-12
|
2023-10-12 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-10-25 | Czechia | Acceptable 2023-10-12
|
2023-10-25 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2023-11-16 | Czechia | Acceptable 2023-10-12
|
2023-11-16 |