Efficacy and safety of Escholzia tablets in adults with insomnia: a biphasic study with a randomized, placebo-controlled, double-blind, 1-month interventional, clinical trial phase (A) and a subsequent prospective, 1-armed, 2-months interventional trial phase (B).

2023-508169-34-00 Protocol Vo02-2023 Therapeutic confirmatory (Phase III) Not authorised

Status Not authorised · 1 EU/EEA countries · 1 sites · Protocol Vo02-2023

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Not authorised
Participants planned 100
Countries 1
Sites 1

Insomnia (ICD-10 F51.0)

The main objective of this study is to show efficacy on perceived sleep quality and safety profile of the newly developed pharmaceutical product Escholzia tablets for the treatment of insomnia according to the ICD-10 F51.0 diagnosis.

Key facts

Sponsor
A.Vogel AG
Participant type
Patients
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Not possible to specify
Decision date (initial)
2023-11-28
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

The main objective of this study is to show efficacy on perceived sleep quality and safety profile of the newly developed pharmaceutical product Escholzia tablets for the treatment of insomnia according to the ICD-10 F51.0 diagnosis.

Secondary objectives 6

  1. Cognitive function
  2. Mood, anxiety, stress
  3. Quality of life
  4. Happiness and satisfaction
  5. Pain
  6. Physiological sleep quantity

Conditions and MedDRA coding

Insomnia (ICD-10 F51.0)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

  1. Voluntary, written, informed consent to participate in the study.
  2. Male or female aged between 18-65 years (inclusive).
  3. Diagnosis of insomnia according to ICD-10 F51.0.
  4. ISI total score > 7.
  5. Habitual bedtime between 9 pm and midnight.
  6. Easy access to internet for daily e-diary.
  7. Freezing capacities available for storage of saliva samples.

Exclusion criteria 17

  1. Body mass index (BMI) <18.0 or >30.0 kg/m2.
  2. Individual is pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential who are unwilling to commit to the use of a medically approved form of contraception throughout the study period.
  3. Any known acute history of a disorder affecting sleep quality, such as narcolepsy, obstructive sleep apnea (OSA), restless leg syndrome (RLS), periodic limb movement syndrome (PLMS) or any organic caused sleep disorders e.g. benign prostatic hyperplasia (BPH), urinary tract infections, irritated bladder
  4. Any known acute history of psychiatric illness (e.g., mono- or bipolar depression, anxiety disorders, personality disorders, borderline personality disorder, psychoses).
  5. Have a significant acute or chronic coexisting illness or any condition which contraindicates entry to the study in the opinion of the Investigator (e.g. migraines, active infections, renal insufficiency, hepatopathy, dementia).
  6. Current or recent (within past 4 weeks) intake of drugs that could influence sleep (e.g., psychotropic, sedatives, hypnotics, nicotine-replacement therapies, over-the-counter sleep aids, hormone therapy, health products and oriental herbs (such as valerian, hops, passionflower, hypericum, etc.).
  7. Current or recent (within 1 year) alcohol abuse, heavy smoking (>10 cigarettes/day), high caffeine intake (>10 glasses/day).
  8. Self-declared regular illicit drug use (including cannabis and cocaine).
  9. Have a high blood pressure (systolic over 159 mmHg or diastolic over 99 mmHg).
  10. Have learning and/or behavioral difficulties such as dyslexia or attention deficit hyperactivity disorder (ADHD).
  11. Have a visual impairment that cannot be corrected with glasses or contact lenses (including color-blindness).
  12. History or planned travel to a different time zone within 1 month of the first visit or/and during the study participation.
  13. Shift-workers.
  14. Not fluent in German.
  15. Have (known) hypersensitivity to plants from the poppy family (Papaveraceae) or known hypersensitivity to the active substance/s (Eschscholzia californica, microcrystalline cellulose, Colloidal anhydrous silica, sodium croscarmellose, glycerol distearate, caramel couleur and Ferrous(III) oxide ).
  16. Participation in another study with any investigational product within 30 days of screening and during the intervention period.
  17. Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

  1. Phase (A): Change in perceived sleep quality as measured with the Insomnia Severity Index (ISI)
  2. Phase (B): Safety and tolerability of treatment according to safety assessment

Secondary endpoints 13

  1. Change in perceived sleep quantity/quality as per the daily sleep diary
  2. Change in physiological sleep quantity as measured via actigraphy (wearable)
  3. Change in daytime sleepiness as measured with the Epworth-Sleepiness-Scale (ESS)
  4. Change in state anxiety as measured with the State-Trait-Anxiety-Inventory (STAI-X1)
  5. Change in mood as measured with the Depression, Anxiety, Stress Scale (DASS-21)
  6. Change in general quality of life as measured with the World Health Organization Quality of Life inventory (WHOQOL)-BREF
  7. Change in happiness and satisfaction via the Oxford Happiness Questionnaire (OHQ)
  8. Domain specific cognitive performance as measured via the Computerized Mental Performance Assessment System (COMPASS)
  9. Change in biomarker for stress via the salivary evening cortisol level (8 pm)
  10. Change in biomarker for sleep readiness via the salivary evening melatonin level (8 pm)
  11. Change in biomarker for chronic stress via the CAR determined as area under the curve (AUC) and increase
  12. Change in pain intensities
  13. Change in sleep quantity as measured via PSG device

Investigational products

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

Test 1

AV-EC2023

PRD10801201 · Product

Active substance
AV-EC2023
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
2.01 g gram(s)
Max total dose
85.51 g gram(s)
Max treatment duration
12 Week(s)
Authorisation status
Not Authorised
MA holder
A.VOGEL AG
Paediatric formulation
No
Orphan designation
No

Placebo 1

Placebo tablet that matches the verum in its sensorical properties and posology, but without any active pharmaceutical ingredient.

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

A.Vogel AG

Sponsor organisation
A.Vogel AG
Address
Grunaustrasse 4
City
Roggwil TG
Postcode
9325
Country
Switzerland

Scientific contact point

Organisation
A.Vogel AG
Contact name
Roland Schoop, PhD

Public contact point

Organisation
A.Vogel AG
Contact name
Andreas Suter, PhD

Third parties 1

OrganisationCity, countryDuties
DAaCRO GmbH & Co. KG
ORG-100048795
 Trier, Germany Code 5

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Germany Not authorised 100 1
Rest of world — 0 —

Investigational sites

Germany

1 site · Not authorised
DAaCRO GmbH & Co. KG
Freelancer, Max-Planck-Strasse 22, Kuerenz, Trier

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-09-15 Germany Not acceptable
2023-11-27
 2023-11-28