Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
122
Countries
1
Sites
1
Cognitive profiles
The primary aim of this study is to assess potential differences in cognitive profiles 6 months post-randomization among older adults hospitalized for proximal hip fractures with perioperative delirium, comparing the intervention arm (citicoline, TRAUSAN26) to the control arm.
Key facts
- Sponsor
- Universita Degli Studi Di Milano Bicocca
- Participant type
- Patients
- Age range
- 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Decision date (initial)
- 2025-10-13
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- PIAM pharmaceuticals S.P.A.
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Therapy, Prophylaxis
The primary aim of this study is to assess potential differences in cognitive profiles 6 months post-randomization among older adults hospitalized for proximal hip fractures with perioperative delirium, comparing the intervention arm (citicoline, TRAUSAN26) to the control arm.
Secondary objectives 3
- - To evaluate differences in cognitive profiles in older adults hospitalized for proximal hip fractures at 0 (discharge), 3, and 6 months after randomization, comparing the intervention (citicoline, TRAUSAN26) to the control arm.
- To evaluate differences in functional profiles from 3 to 6 months post-randomization between the intervention (citicoline, TRAUSAN) and control arm.
- To evaluate differences in adverse events between the intervention and control groups during the 6-month follow-up period post-randomization.
Conditions and MedDRA coding
Cognitive profiles
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Individuals aged >65 years, who were admitted for a proximal hip fracture to the Orthogeriatric Unit and underwent hip fracture surgery (IRCCS San Gerardo dei Tintori Foundation, Monza)
- Clinical diagnosis of delirium (arising from any cause), ascertained pre- or post-operatively using the 4AT score (cut-off > 4/12)
- Diagnosis of chronic vascular encephalopathy (corroborated by clinical documentation or previous cerebral imaging), i.e. evidence of neurological and cognitive disorder resulting from cerebrovascular accidents
- Prognosis quoad vitam ≥ 3 months
- Availability of a formal or informal caregiver who may help the participant to take the prescribed dose and follow the visit schedule
- Informed consent, freely granted from the participant or from his/her legal guardian (or from an impartial witness in cases where the patient is unable to sign but clearly expresses the will to participate), and acquired before the randomization
Exclusion criteria 5
- Diagnosis of severe dementia (defined by medical clinical records or by the presence of an AD8 score >6 and a Global Deterioration Scale score >6)
- Current therapy with citicoline
- Any contraindications to citicoline (TRAUSAN), including allergy to acetylsalicylic acid or excipients contained in the drug, previous adverse reactions to citicoline, hypertonia of the parasympathetic nervous system, low-sodium diet
- Clinical conditions or situations other than the condition being studied, which in the opinion of the researchers could interfere with the study or not allow optimal participation
- Persistent in-hospital delirium (> 6 days or still present 24 hours prior to discharge).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The Montreal Cognitive Assessment (MoCA) performed before discharge and at 6 months post-randomization will allow to assess the primary objective.
Secondary endpoints 3
- Montreal Cognitive Assessment (MoCA) performed before discharge and at 3 and 6months post-randomization
- Short Physical Performance Battery (SPPB), performed at 3 and 6months post-randomization
- Rates of adverse events (quantity/seriousness) during the 6-months follow-up after randomization
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
TRAUSAN 1000 mg soluzione orale
PRD8935907 · Product
- Active substance
- Citicoline
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- ORAL
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 180 g gram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- N06BX06 — CITICOLINE
- Marketing authorisation
- 046461024
- MA holder
- PIAM FARMACEUTICI SPA
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universita Degli Studi Di Milano Bicocca
- Sponsor organisation
- Universita Degli Studi Di Milano Bicocca
- Address
- Piazza Dell'ateneo Nuovo 1
- City
- Milan
- Postcode
- 20126
- Country
- Italy
Scientific contact point
- Organisation
- Universita Degli Studi Di Milano Bicocca
- Contact name
- Giuseppe Bellelli
Public contact point
- Organisation
- Universita Degli Studi Di Milano Bicocca
- Contact name
- Giuseppe Bellelli
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Authorised, recruitment pending | 122 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 25 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-522306-21-00_fp | 1.3 |
| Protocol (for publication) | D4_ Patient questionnaire 4-AT_ok | 1 |
| Protocol (for publication) | D4_ Patient questionnaire AD8_ok | 1 |
| Protocol (for publication) | D4_ Patient questionnaire ADL_ok | 1 |
| Protocol (for publication) | D4_ Patient questionnaire CAS_ok | 1 |
| Protocol (for publication) | D4_ Patient questionnaire CCI_ok | 1 |
| Protocol (for publication) | D4_ Patient questionnaire CFS classification tree_ok | 1 |
| Protocol (for publication) | D4_ Patient questionnaire DeliriumOMeter_ok | 1 |
| Protocol (for publication) | D4_ Patient questionnaire IADL_ok | 1 |
| Protocol (for publication) | D4_ Patient questionnaire Indice di fragilita_ok | 1 |
| Protocol (for publication) | D4_ Patient questionnaire m-RASS_ok | 1 |
| Protocol (for publication) | D4_ Patient questionnaire MNA SF ita_ok | 1 |
| Protocol (for publication) | D4_ Patient questionnaire MoCA-Test-Italian_ok | 1 |
| Protocol (for publication) | D4_ Patient questionnaire NEWS2 score_ok | 1 |
| Protocol (for publication) | D4_ Patient questionnaire NMS_ok | 1 |
| Protocol (for publication) | D4_ Patient questionnaire SPPB_ok | 1 |
| Protocol (for publication) | D4_Patient Diary | 1 |
| Protocol (for publication) | D4_Patient questionnaire GDS_ok | 1 |
| Recruitment arrangements (for publication) | K1_recruitment arrangement | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults | 1.3 |
| Subject information and informed consent form (for publication) | L2_ Letter for the general medicine | 1 |
| Subject information and informed consent form (for publication) | L2_ Privacy ICF | 1.1 |
| Subject information and informed consent form (for publication) | L2_Patient card_fp | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Trausan_2024 | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_2025-522306-21-00 | 1.2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-30 | Italy | Acceptable 2025-09-29
|
2025-10-13 |