Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
1,000
Countries
1
Sites
1
CSF disorders
Individualized assessment of CSF flow in CSF spaces and CNS Individualized assessment of CSF clearance
Key facts
- Sponsor
- Oslo University Hospital HF
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 29 Jan 2025 → ongoing
- Decision date (initial)
- 2025-01-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Oslo university hospital
External identifiers
- EU CT number
- 2024-519936-18-00
- EudraCT number
- 2015-001673-40
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
Individualized assessment of CSF flow in CSF spaces and CNS
Individualized assessment of CSF clearance
Secondary objectives 1
- New diagnostics of CSF flow in humans
Conditions and MedDRA coding
CSF disorders
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Individuals with cerebral symptoms (including cognitive impairment and fatigue).
- Individuals with imaging evidence of neurological disease (CSF disorders, hydrocephalus, neoplasia in central nervous system).
- Individuals who receive medical treatment intended to treat the CNS (patients receiving intrathecal chemotherapeutic drugs to prevent tumor spread).
Exclusion criteria 5
- Contrast allergy
- Renal failure
- < 18 years of age or >80 years of age
- Pregnant women
- Women who are breastfeeding
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- MRI evidence of CSF flow Blood-based determination of CSF clearance
Secondary endpoints 1
- Quantitative estimation of CSF flow and clearance
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP185449 · ATC
- Active substance
- Gadobutrol
- Route of administration
- INTRATHECAL USE
- Max daily dose
- 0.50 mmol millimole(s)
- Max total dose
- 0.50
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- V08CA09 — GADOBUTROL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Oslo University Hospital HF
- Sponsor organisation
- Oslo University Hospital HF
- Address
- Taarnbygget, Kirkeveien 166 Kirkeveien 166
- City
- Oslo
- Postcode
- 0450
- Country
- Norway
Scientific contact point
- Organisation
- Oslo University Hospital HF
- Contact name
- Per Kristian Eide
Public contact point
- Organisation
- Oslo University Hospital HF
- Contact name
- Per Kristian Eide
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Oslo University Hospital HF ORG-100021349
|
Oslo, Norway | Code 5 |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Ongoing, recruiting | 1,000 | 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 |
|---|---|---|---|---|---|
| Norway | 2025-01-29 | 2025-01-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol EU CT 2024-519936-18-00_SM5_v8_Clean version | 8 |
| Protocol (for publication) | D1_Protocol EU CT 2024-519936-18-00_SM5_v8_For publication | 8 |
| Protocol (for publication) | D1_Protocol EU CT 2024-519936-18-00_SM5_v8_With changes | 8 |
| Protocol (for publication) | D1_Protocol EU CT 2024-519936-18-00_v7-SM5_For Publication | 7 |
| Recruitment arrangements (for publication) | K1_Recruitment _EU CT 2024-519936-18-00 | 2 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_v10_EU CT 2024-519936-18-00_Clean version | 10 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_v10_EU CT 2024-519936-18-00_Tracked changes | 10 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_v11_EU CT 2024-519936-18-00_Tracked changes | 11 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_v9_EU CT 2024-519936-18-00_Clean version | 9 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_v9_EU CT 2024-519936-18-00_Tracked changes | 9 |
| Synopsis of the protocol (for publication) | D1_NO_Synopsis_EU CT 2024-519936-18-00-SM5_Clean version | 7 |
| Synopsis of the protocol (for publication) | D1_NO_Synopsis_EU CT 2024-519936-18-00-SM5_v8_With tracked changes | 8 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-08 | Norway | Acceptable with conditions 2025-01-27
|
2025-01-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-22 | Norway | Acceptable 2025-05-20
|
2025-05-20 |
| 3 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-09-28 | Norway | Acceptable with conditions 2025-12-19
|
2025-12-19 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-26 | Norway | Acceptable with conditions 2025-12-19
|
2026-03-26 |