Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
200
Countries
1
Sites
1
Schizophrenia
biomarkers predicting clozapine response
Key facts
- Sponsor
- Region Hovedstaden
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 10 Oct 2024 → ongoing
- Decision date (initial)
- 2024-10-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515338-34-01
- EudraCT number
- 2019-003128-19
- ClinicalTrials.gov
- NCT05316883
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Others, Pharmacokinetic, Pharmacodynamic
biomarkers predicting clozapine response
Conditions and MedDRA coding
Schizophrenia
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-515338-34-00 | Biomarkers in clozapine-responding schizophrenia | Psykiatrisk Center Glostrup |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- According to ICD-10 fulfill diagnostic criteria of schizophrenia (F20.x), chronical paranoid psychoses (F22), Schizoaffective psychoses (F25) or other non-organic psychoses (F28/29)
- Age 18-64 years
- Legally competent
- Stable antipsychotic treatment during the last month
- Being treatment refractory according to TRIPP-guidelines (Howes et al. 2017) defined as having tried at least two antipsychotic drugs in sufficient dosage (≥600 mg clorpromazine equivalent) for a sufficient time (≥ 6 weeks) without sufficient symptom improvement (still a moderate level of positive symptoms).
- Recreational use of substances is allowed as long as it does not interfere with compliance
- Fertile females must use safe contraception (spiral or any hormonal contraception).
Exclusion criteria 8
- Involuntarily psychiatric admittance during the study
- Substance abuse that interfere with compliance
- Any condition that interfere with compliance for obtaining bloodsamples weekly
- Pregnancy (will be verified by urine-HCG-test in fertile females)
- Females who are breastfeeding
- Toxic or idiosyncratic agranulocytosis in the past
- Reduced bone marrow function according to blood samples (normal function defined as leucocytes > 3.3*109/l and neutrophil > 2.0*109/l)
- According to information from patient and available files, no o Current uncontrolled epilepsy o Current circulatory collapse and / or CNS depression for any cause o Current severe kidney, heart or liver disease o Current paralytic ileus
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Permeability of the blood-brain barrier blood and CSF inflammatory cytokines
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP1158876 · ATC
- Active substance
- Clozapine
- Route of administration
- ORAL USE
- Max daily dose
- 900 mg milligram(s)
- Max total dose
- 75600 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- N05AH02 — CLOZAPINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Hovedstaden
- Sponsor organisation
- Region Hovedstaden
- Address
- Nordstjernevej 41
- City
- Glostrup
- Postcode
- 2600
- Country
- Denmark
Scientific contact point
- Organisation
- Psykiatrisk Center Glostrup
- Contact name
- Jimmi Nielsen
Public contact point
- Organisation
- Psykiatrisk Center Glostrup
- Contact name
- Jimmi Nielsen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 200 | 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 |
|---|---|---|---|---|---|
| Denmark | 2024-10-10 | 2024-10-10 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol EU CT 2024-515338-34-01 | 4 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF - adults -Informed consent | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF - adults -Subject information | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC Leponex tabletter 25 mg og 100 mg | 1 |
| Synopsis of the protocol (for publication) | Protocol Synopsis _DK EU CT 2024-515338-34-01 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-10 | Denmark | Acceptable 2024-10-22
|
2024-10-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-09-13 | Denmark | Acceptable 2025-09-30
|
2025-10-01 |