Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
100
Countries
1
Sites
1
Adult hydrocephalus
Individualized determination of ventricular water absorption capacity in patients with hydrocephalus
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], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Trial duration
- 29 Jan 2025 → ongoing
- Decision date (initial)
- 2025-01-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
- Funding sources
- Oslo university hospital
External identifiers
- EU CT number
- 2024-519933-53-00
- EudraCT number
- 2022-002094-29
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
Individualized determination of ventricular water absorption capacity in patients with hydrocephalus
Secondary objectives 4
- Establish a pharmacokinetic model for ventricular water absorption in communicating and non-communicating hydrocephalus to identidy shunt-dependent individuals.
- Establish imaging information about water absorption from ventricles using PET.
- Establish the safety and tolerability of the method of ventricular 15-oxygen-water infusion testing in hydrocephalus patients.
- Compare CSF molecular profile with ventricular water absorption capacity.
Conditions and MedDRA coding
Adult hydrocephalus
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Adult patients with communicating hydrocephalus
- Adult patients with non-communicating hydrocephalus
Exclusion criteria 3
- Patients with impaired ability to consent.
- Patients < 18 years of age or >80 years of age.
- Pregnant women or women who are breastfeeding.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- From venous blood-samples during ventricular 15-oxygen-water infusion testing establish population pharmacokinetic measures of ventricular water absorption capacity on the individual basis.
Secondary endpoints 1
- Image the ventricular water absorption to brain using positron emission tomography (PET) imaging. for communicating and non-communicating hydrocephalus. Endpoints of safety and tolerability are defined as increase in intracranial pressure and symptoms of intracranial hypertension
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11947537 · Product
- Active substance
- O15-WATER
- Substance synonyms
- MT-100, Oxygen-15 Water, Oxidane
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRACEREBROVENTRICULAR (ICV)
- Max daily dose
- 10 ml millilitre(s)
- Max total dose
- 10 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- OSLO UNIVERSITY HOSPITAL
- Paediatric formulation
- No
- Orphan designation
- 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 | 100 | 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 9 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 2024-519933-53-00_v5_For publication | 5 |
| Recruitment arrangements (for publication) | K1_Recruitment _EU CT 2024-519933-53-00 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_EU CT 2024-519933-53-00_Ren versjon | 6 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_EU CT 2024-519933-53-00_v3_25-10-2022_Clean version | 3 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_EU CT 2024-519933-53-00_v3_25-10-2022_TrackedChange | 3 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_EU CT 2024-519933-53-00_v4_24-06-2023_CleanVersion | 4 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_EU CT 2024-519933-53-00_v5_18-05-2025_Clean Version | 5 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_EU CT 2024-519933-53-00_v6_TrackedChange | 6 |
| Synopsis of the protocol (for publication) | D1_NO_Synopsis_EU CT 2024-519933-53-00 | 5 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-29 | Norway | Acceptable with conditions 2025-01-29
|
2025-01-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-18 | Norway | Acceptable 2025-08-11
|
2025-08-29 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-28 | Norway | Acceptable 2025-08-11
|
2025-09-28 |