DARIdorexant efficacy on the COGnitive performance in patients with chronic insomnia disorder. DARI-COG Study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universita' Degli Studi Di Roma Tor Vergata

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

11 Jul 2025 → ongoing

Decision date (initial)

2025-03-04

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

Confirm in a real-world study the effectiveness of daridorexant 50 mg/day in patients with chronic insomnia disorder, who will start the drug as common clinical practice and according to indication to monitor subjective sleep and daytime symptoms at 3 month and 6 month follow-up visit

Secondary objectives 1

1. 1) Evaluate the impact of daridorexant 50 mg/day, which will be prescribed according to common clinical practice and guidelines on the cognitive performance (attention and memory domains) in patients with insomnia after 3 and 6 months of treatment; 2) Correlate the changes in subjective sleep quality and cognitive performance at 3-month and 6-month follow-up visits; 3) Evaluate the effectiveness of daridorexant 50 mg/day on subjective sleep and wake parameters at the 3-month and 6-month follow-up visits; 4) Investigate the effectiveness of daridorexant 50 mg/day on subjective sleep and wake parameters at the 3-month and 6-month follow-up visits; 5) Assess the tolerability and retention rate of daridorexant 50 mg/day after 3 and 6 months of treatment; 6) Monitor subjective depressive symptoms after 3 and 6 months of follow-up; 7) Describe the quality of life at the 3- and 6-month follow-up visits; 8) Correlate the changes in subjective sleep quality, quality of life and depressive symptoms at 3- and 6-month follow-up visits.

Conditions and MedDRA coding

Insonnia cronica

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 1. Male and female patients aged ≥18 years old and < 65 years old with a diagnosis of chronic insomnia disorder according to the ICSD-3; 2. Starting daridorexant 50 mg daily according to the regulatory approved indication; 3. Patients who are able and willing to give written informed consent, willing and able to understand the purpose of the study, including possible risks and side effects, and willing and able to comply with the study requirements.

Exclusion criteria 1

1. 1. Concomitant sleep disorders 2. Major psychiatric disorders 3. Patients contraindicated for daridorexant use (according to SmPC) 4. Dose adjustment of daridorexant or prescription to 25 mg/day 5. Pregnancy or planned pregnancy 6. History of suicide ideations and/or attempts 7. History of epilepsy 8. Previous cerebrovascular diseases 9. Heavy smoking 10. Shift-work 11. Use of drugs affecting cognition 12. Body Mass Index >35

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1. Change in insomnia severity index (ISI) total score at 3- and 6-month follow-up visits; 2. Change in subjective total sleep time (sTST) measured by sleep diary in the 7 days before the visit planned at 3- and 6-month follow-up;

Secondary endpoints 1

1. Change in cogn perf (attention and memory) measured by neuropsychological tests at the 3and 6monthFUvisits;Change in PSQI total and sub-items scores at 3and 6monthFUvisits;Change in ESS scores at 3and 6monthFUvisits;Change in MEQ scores at 3and 6monthFUvisits;Change in Beck Depression Inventory-II total score at 3and 6monthFUvisits;Change in the mental and physical component of the SF-12 at 3and 6monthFUvisits.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universita' Degli Studi Di Roma Tor Vergata

Sponsor organisation

Universita' Degli Studi Di Roma Tor Vergata

Address

Via Montpellier 1

City

Rome

Postcode

00133

Country

Italy

Scientific contact point

Organisation

Universita' Degli Studi Di Roma Tor Vergata

Contact name

Claudio Liguori

Public contact point

Organisation

Universita' Degli Studi Di Roma Tor Vergata

Contact name

Claudio Liguori

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 15 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications