Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
57
Countries
1
Sites
3
Amyotrophic Lateral Sclerosis
Key facts
- Sponsor
- Itb-Med AB
- 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 Nov 2025 → ongoing
- Decision date (initial)
- 2023-12-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-506174-12-00
- ClinicalTrials.gov
- NCT06453668
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Amyotrophic Lateral Sclerosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10002026 | Amyotrophic lateral sclerosis | 100000004852 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Itb-Med AB
- Sponsor organisation
- Itb-Med AB
- Address
- Sonja Kovalevskys Gata 4, S:t Matteus S:t Matteus
- City
- Stockholm
- Postcode
- 113 66
- Country
- Sweden
Scientific contact point
- Organisation
- Itb-Med AB
- Contact name
- Kellie Calderon
Public contact point
- Organisation
- Itb-Med AB
- Contact name
- Clinical Trial Information
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruiting | 57 | 3 |
| 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 |
|---|---|---|---|---|---|
| Sweden | 2024-04-03 | 2024-04-16 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-39866
- Halt date
- 2024-08-05
- Member states concerned
- Sweden
- Publication date
- 2024-08-09
- Reason
- Safety related (clinical or pre-clinical results), Medicinal Product related
- Follow-up measures
- Sponsor halts enrolment and dosing.
Follow-up of participants per protocol will continue, in addition to the disposals of the Urgent Safety Measures reported by the Sponsor with code USM02. - Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-14 | Sweden | Acceptable 2023-12-13
|
2023-12-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-02-12 | Sweden | Acceptable 2024-03-20
|
2024-03-21 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-03-29 | Sweden | Acceptable 2024-03-20
|
2024-03-29 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-10-07 | Sweden | Acceptable 2024-12-10
|
2024-12-11 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-12-20 | Sweden | Acceptable 2025-02-17
|
2025-02-24 |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-08-21 | Sweden | Acceptable 2025-11-06
|
2025-11-06 |
| 7 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-11-28 | Sweden | Acceptable 2026-02-16
|
2026-02-16 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-03-11 | Sweden | Acceptable 2026-02-16
|
2026-03-11 |