HyperChrono

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Les Hopitaux Universitaires De Strasbourg

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10], Not possible to specify

Trial duration

7 Sep 2024 → ongoing

Decision date (initial)

2023-12-14

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The main objective of this trial is to demonstrate, in adult patients affected with IH, the efficacy of 6 weeks of chronobiotherapy (combining evening fast release 2mg melatonin and morning bright light therapy), compared to placebo therapy (combining evening placebo drug and morning placebo light), on reducing IH symptoms as measured by the Idiopathic Hypersomnia Severity Scale (IHSS).

Conditions and MedDRA coding

IDIOPATHIC HYPERSOMNIA

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Male or female patient
2. Age ≥ 18 and ≤ 45 years at signature of informed consent form
3. Diagnosed with Idiopathic hypersomnia in a reference/competence center of hypersomnia rare disease network according to ICSD-3 criteria (International classification of sleep disorders) with symptoms lasting since >3 months and a total sleep time ≥11hours objectified with a 24h continuous polysomnography realized during the last 5 years
4. Patient with stable medication during the 11 weeks of participation to the study (except for drugs excluding participation.
5. Patient able to be compliant with chronobiotherapy during the required time and at the set schedule.
6. For female patient: effective efficient contraception or sexual abstinence during the month preceding the inclusion and all along the study
7. Patient who have given written informed consent and are able to understand the objectives and risks associated to the research.
8. Patient affiliated to a social security insurance

Exclusion criteria 29

1. Other primary or secondary hypersomnia (narcolepsy, Kleine-Levin syndrome, post-traumatic hypersomnia, hypersomnia due to medication or substance abuse…)
2. Photosensitive epilepsia or migraine
3. Prior intolerance to cellulose or exogenous melatonin
4. Other intrinsic sleep disorder according to ICSD-3 criteria (sleep apnea syndrome, restless legs syndrome, insomnia)
5. Drugs metabolized by CYP1A2 intake prohibited during the study: antivitamin K, fluvoxamine, cimetidine, carbamazepine, rifampicin…
6. Pregnancy, breastfeeding.
7. Sleep promoting drugs (benzodiazepines, z-drugs, sodium oxybate, antihistaminics…)
8. Participation in another interventional clinical trial with an exclusion period
9. Patient with difficulty to read or understand French, or inability to understand the delivered information
10. Patient in emergency situation
11. Significant psychiatric comorbidities (current severe depressive episode based on the DSM-V criteria, risk of suicide, schizophrenia, bipolar disorder).
12. Patient in life-threatening situation
13. Patient sous sauvegarde de justice
14. Patient under guardianship or limited guardianship
15. Known systemic or severe acute disease (auto-immune diseases…)
16. Substance / alcohol /cigarette dependence
17. Recent transmeridian travel (> 2 time zones) within the month before the start of the study
18. Wake promoting-drugs (modafinil, pitolisant, methylphenidate, solriamfétol chlorhydrate)
19. History of shift/night work reported within the 6 months preceding the study
20. Irregular sleep habits (more than 2 hours of delay or advance in bedtime ≥ 3 nights over a week)
21. Circadian sleep-wake rhythm disorders according to ICSD-3 criteria (advanced or delayed sleep phase syndrome, …)
22. • Consumption of excessive amounts of caffeine, defined as greater than 600 mg of caffeine (coffee, tea, cola, energy drinks, or other caffeinated beverages per day ; 1 cup of coffee is approximately 120 mg)
23. • Patient unwilling to refrain from driving and/or operating dangerous or hazardous machinery during times of heightened sleepiness or fatigue due to the medication
24. Psychotropics and drugs inducing level 3 sleepiness according to the ANSM (French National Agency for Medicines and Health Products Safety) gradation.
25. beta-blockers
26. regular anti-inflammatory drug intake
27. Exogenous melatonin and/or serotonin and or tryptohane (as a drug or a dietary supplement)
28. Medical history of ophthalmologic diseases causing visual impairment: retinopathy, age-related macular degeneration, macular hole, epiretinal membrane; cataract; optic neuropathy.
29. On-going medication with a photosensibilizing drug

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the difference in IHSS score before and after 6 weeks of active chronobiotherapy (2mg melatonin and BLT) or 6 weeks of placebo conditions (placebo drug and placebo light).

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Les Hopitaux Universitaires De Strasbourg

Sponsor organisation

Les Hopitaux Universitaires De Strasbourg

Address

1 Place De L Hopital, Cs 80426 Cs 80426

City

Strasbourg Cedex

Postcode

67091

Country

France

Scientific contact point

Organisation

Les Hopitaux Universitaires De Strasbourg

Contact name

BOURGIN Patrice

Public contact point

Organisation

Les Hopitaux Universitaires De Strasbourg

Contact name

BOURGIN Patrice

Locations

1 EU/EEA country · 5 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 20 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