Overview
Sponsor-declared trial summary
central diabetes insipidus
Primary objective To determine the effect of internasal OXT (24 IU twice daily) compared to placebo for 28 (+/- 2) days on: ▪ Change in anxiety levels assessed with the State-Trait Anxiety Inventory (Trait-Anxiety Scale, STAI-T) ▪ Change in correct recognition of facial & body expressions assessed upon the EmBody/EmFac…
Key facts
- Sponsor
- Universitaetsspital Basel
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Metabolism [G03], Diseases [C] - Hormonal diseases [C19]
- Trial duration
- 26 Feb 2025 → ongoing
- Decision date (initial)
- 2025-10-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516813-19-00
- ClinicalTrials.gov
- NCT06036004
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
Primary objective
To determine the effect of internasal OXT (24 IU twice daily) compared to placebo for 28 (+/- 2) days on:
▪ Change in anxiety levels assessed with the State-Trait Anxiety Inventory (Trait-Anxiety Scale, STAI-T)
▪ Change in correct recognition of facial & body expressions assessed upon the EmBody/EmFace Task
We hypothesize that the decrease in anxiety and/or increase in correct classification of facial & body expressions will be greater in the OXT group than in the placebo group.
Secondary objectives 7
- Emotion recognition and empathy
- Hormonal and subjective response to psychological stress
- Amygdala and subjective response in the functional MRI scan
- Other psychological measures
- Metabolic parameters
- Objective assessment of a third person
- Safety measure
Conditions and MedDRA coding
central diabetes insipidus
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Adult patients with a confirmed diagnosis of central diabetes insipidus based on accepted criteria
- Heightened anxiety levels (STAI – Trait subscale ≥ 39 score points) or alexithymia levels (im- paired ability to identify and describe feelings; TAS-20 total ≥ 52 score points)
- Stable hormone replacement therapy for at least three months with desmopressin and, in case of additional anterior pituitary deficiencies, with the respective substitution therapies
- Adult patients aged over 18 years
Exclusion criteria 8
- Participation in a trial with investigational drugs within 30 days
- Pregnancy and breastfeeding within the last 8 weeks
- Active substance use disorder within the last six months
- Consumption of alcoholic beverages >15 drinks/week
- Unwilling to use a medically acceptable form of contraception throughout the study period (female of childbearing potential only)
- Current or previous psychotic disorder (e.g., schizophrenia spectrum disorder)
- Prolonged QTc-time > 470 ms assessed with a 12-lead electrocardiogram.
- Hypersensitivity to the excipients substances methyl p-hydroxybenzoate (E218) and propyl p- hydroxybenzoate (E216)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Trait anxiety level and correct classifications of facial & body expression after 28 (+/-2) days of treatment assessed with the STAI-T and the EmBody/EmFace Task. ▪ The STAI-T comprises 20 items scoring 1-4 points each. ▪ The EmBody/EmFace comprises 84 items scoring correct or incorrect each.
Secondary endpoints 7
- Emotion recognition and empathy
- Hormonal and subjective response to psychological stress
- Amygdala and subjective response in the functional MRI scan
- Further psychological outcomes
- Metabolic outcomes
- Objective assessment of a close third person
- Safety outcome
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
—
SCP107200984 · ATC
- Route of administration
- NASAL SPRAY
- Max daily dose
- 48 IU international unit(s)
- Max total dose
- 80 IU international unit(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- H01BB02 — OXYTOCIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The original label is removed from the primary packaging and the clinical trial medication (CTM) label is applied.
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitaetsspital Basel
- Sponsor organisation
- Universitaetsspital Basel
- Address
- Petersgraben 4
- City
- Basel
- Postcode
- 4031
- Country
- Switzerland
Scientific contact point
- Organisation
- Universitaetsspital Basel
- Contact name
- Cihan Atila
Public contact point
- Organisation
- Universitaetsspital Basel
- Contact name
- Cihan Atila
Locations
2 EU/EEA countries · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 20 | 1 |
| Netherlands | Ongoing, recruiting | 50 | 1 |
| Rest of world
Switzerland
|
— | 62 | — |
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 |
|---|---|---|---|---|---|
| Germany | 2026-03-03 | 2026-04-28 | |||
| Netherlands | 2025-02-26 | 2025-03-06 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 20 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-516813-19-00 | 7.0 |
| Protocol (for publication) | D1_Protocol_2024-516813-19-00_track-change | 5.0 |
| Protocol (for publication) | D4_patient facing documents_Patient_Diary_DE | 1.1 |
| Protocol (for publication) | D4_patient facing documents_Questionnaire_DE | 1 |
| Protocol (for publication) | D4_Questionnaire_OxyTUTION_Vragenlijst_STAI-T | 1.0 |
| Protocol (for publication) | D4_Questionnaire_OxyTUTION_Vragenlijst_TAS-20 | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment_Arrangement | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment_Statement | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment_Material | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment_Material | 2.0 |
| Subject information and informed consent form (for publication) | L1 PIF OxyTUTION v2 20241126_tracked_changes | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF_ vooronderzoek _OxyTUTION | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_ICF adults | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_DE | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_Prescreening_DE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_Patient_Diary | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_Questionnaire | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Oxytocin | 102 E |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis NL 2024_516813-19-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol_Synopsis_DE 2024_516813-19-00 | 1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-11 | Netherlands | Acceptable 2025-01-08
|
2025-01-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-03 | Netherlands | Acceptable 2025-04-01
|
2025-04-02 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2025-07-07 | 2025-10-02 | ||
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-16 | Netherlands | Acceptable 2025-12-22
|
2025-12-29 |