Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
30
Countries
1
Sites
2
Patients with central neuropathic pain POST stroke
Key facts
- Sponsor
- Institut National De La Sante Et De La Recherche Medicale
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 6 Jan 2025 → ongoing
- Decision date (initial)
- 2023-08-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Patients with central neuropathic pain POST stroke
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut National De La Sante Et De La Recherche Medicale
- Sponsor organisation
- Institut National De La Sante Et De La Recherche Medicale
- Address
- 101 Rue De Tolbiac
- City
- Paris
- Postcode
- 75013
- Country
- France
Scientific contact point
- Organisation
- Institut National De La Sante Et De La Recherche Medicale
- Contact name
- Valeria MARTINEZ
Public contact point
- Organisation
- Institut National De La Sante Et De La Recherche Medicale
- Contact name
- Valeria MARTINEZ
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 30 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Raymond Poincare Hospital
Anesthesiology, 104 Boulevard Raymond Poincare, 92380, Garches
Hopital Ambroise Pare
Pain Assessment and Treatment Centre, 9 Avenue Charles De Gaulle, 92100, Boulogne-Billancourt
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 |
|---|---|---|---|---|---|
| France | 2024-02-09 | 2024-02-09 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-64594
- Halt date
- 2024-12-20
- Member states concerned
- France
- Publication date
- 2024-12-20
- Reason
- Sponsor decision
- Explanation
- voir serious breach n°1
- Follow-up measures
- voir serious breach n°1
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-28 | France | Acceptable 2023-07-12
|
2023-08-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-01-23 | France | Acceptable 2024-03-11
|
2024-03-18 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-13 | France | Acceptable 2025-05-12
|
2025-05-16 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-01-29 | France | Acceptable 2026-02-18
|
2026-02-26 |