The sedative effects and local tolerability of nasal administration of remimazolam using a Soft Mist Nasal Administration Device

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Stichting Radboud universitair medisch centrum

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Trial duration

10 Mar 2025 → 13 Apr 2025

Decision date (initial)

2025-01-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Radboud University Medical Center (Radboudumc)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Pharmacodynamic, Safety, Therapy

In this study two dosages of 20 mg remimazolam, adding up to a total dose of 40 mg, will be administered intranasally using a specific nasal atomizer (NAA). Preceding the administration of
remimazolam, the nasal mucosa will be locally anesthetized with 20 mg lidocaine, also applicated with a nasal atomizer, to prevent local irritation. We will evaluate the sedative effect and the comfort level for the subjects.

Secondary objectives 5

1. To assess the level of sedation over time after topical intranasal application of 40 mg remimazolam, preceded by the local administration of 20 mg lidocaine, using a Soft Mist Nasal Administration Device
2. To assess other measures of sedation level over time after topical intranasal application of 40 mg remimazolam, preceded by the local administration of lidocaine, using a Soft Mist Nasal Administration Device.
3. To investigate the comfort level for the subjects after nasal administration of 40 mg remimazolam, preceded by the local administration of lidocaine, using a Soft Mist Nasal Administration Device
4. To investigate pharmacokinetics after nasal administration of 40 mg remimazolam, preceded by the local administration of lidocaine, using a Soft Mist Nasal Administration Device
5. To explore safety of nasal administra-tion of 40 mg remimazolam, preceded by the local administration of lidocaine, using a Soft Mist Nasal Administration Device.

Conditions and MedDRA coding

stress anxiety

Regulatory references

Plan to share IPD

Yes

IPD plan description

Anonymous data will be available upon reasonable request

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Age between 18-60 years
2. Lean body weight >= 50 kg
3. ASA physical status class I

Exclusion criteria 16

1. • Inability to cooperate
2. • History of hepatic, renal and coagulation diseases
3. • History of epileptic insult
4. • Allergy to any of the study drug concipients
5. • Use of benzodiazepines in the 4 weeks preceding IMP administration
6. • Nasal medication use in the 4 weeks preceding IMP administration
7. • Alcohol and drugs misuse in the 2 weeks preceding IMP administration
8. • Alcohol use during 24 hours preceding IMP administration
9. • Respiratory tract pathology
10. • Predicted difficult airway
11. • Obstruction of nasal passage at either side
12. • Chronic rhinitis
13. • Chronic sinusitis
14. • (Possible) pregnancy
15. • Breast feeding women
16. • No written informed consent by subject

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. • Maximum decrease in Bispectral Index (BIS) value compared with baseline BIS.

Secondary endpoints 5

1. • Changes in BIS signal over time.
2. • Richmond Agitation Sedation Scale (RASS) score at baseline and T = 5, 10, 15, 20, 30, 40, 50, 60, 90, 180 min. • Self-reported bipolar measure of alertness/drowsiness on a 0-100 VAS-scale at baseline and T = 5, 10, 15, 20, 30, 40, 50, 60, 90, 180 min. • Self-reported bipolar measure of agitation/relaxation on a 0-100 VAS scale at baseline and T = 5, 10, 15, 20, 30, 40, 50, 60, 90, 180 min. • Self-reported unipolar measure of perceived drug effects on a 0-100 VAS scale at baseline and T = 5, 10
3. • Self-reported bipolar measure of alertness/drowsiness on a 0-100 VAS-scale at baseline and T = 5, 10, 15, 20, 30, 40, 50, 60, 90, 180 min.
4. • Self-reported bipolar measure of agitation/relaxation on a 0-100 VAS scale at baseline and T = 5, 10, 15, 20, 30, 40, 50, 60, 90, 180 min.
5. • Self-reported unipolar measure of perceived drug effects on a 0-100 VAS scale at baseline and T = 5, 10, 15, 20, 30, 40, 50, 60, 90, 180 min.

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Stichting Radboud universitair medisch centrum

Sponsor organisation

Stichting Radboud universitair medisch centrum

Address

Geert Grooteplein Zuid 10

City

Nijmegen

Postcode

6525 GA

Country

Netherlands

Scientific contact point

Organisation

Stichting Radboud universitair medisch centrum

Contact name

Lucas van Eijk

Public contact point

Organisation

Stichting Radboud universitair medisch centrum

Contact name

Lucas van Eijk

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 9 files

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

Application history

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