Eschscholzia Study

A. Vogel AG

Status and phase: Not yet enrolling; Phase 3

Conditions: Sleep

Treatments: Drug: Eschscholzia tablets; Drug: Placebo Tablets

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06795776

5'000'642

Details and patient eligibility

About

This is a clinical study aimed at evaluating the efficacy and safety of Eschscholzia tablets in adults with insomnia disorder symptoms. The study will be conducted at one center, participants will randomly be assigned to either the treatment or placebo. Neither the participants, nor the researchers will know who is receiving the treatment (double-blind). The study is also placebo-controlled, meaning some participants receive a dummy pill instead of the actual treatment, and it involves a parallel-group design, where the treatment and placebo groups are studied at the same time. The study is exploratory, meaning it is investigating new possibilities and is not yet fully conclusive.

The purpose of this study is to determine main efficacy and safety of the newly developed herbal medicinal product Eschscholzia tablets. A total of 100 subjects will be enrolled in the study and assigned to either Eschscholzia tablets or placebo.

The Local Ethics Committee at the clinical site has given their approval for the study to be run.

Male or female participats aged between 18 and 75 years (inclusive), generally healthy and with a self reported history of disturbed sleep on at least 3 nights per week for at least the prior 1 month with a self-reported impact on daytime functioning are allowed to take part in the study.

Overall, the study has the following visits in the clinic, planned for each patient: Screening visit, Study centre Visit 2, Final study centre Visit 3. Between these visits participants will go through a "run-in" period (1 week between Visit 1 and 2) and treatment period (1 month between visit 1 and 3), both at home. Upon visit 2 participants will obtain the study product. They will be asked to administer a daily dose of 2 tablets (either Eschscholzia tablets or Placebo) over a 4-week period, starting from Visit 2 and continuing until Visit 3. Every intake of study product should be noted on the sleep diary pages that the participants obtain.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Voluntary, written, informed consent to participate in the study

• Self reported difficulty or maintaining sleep or waking too early, or daytime impairement or distress based on subject's information related to sleep pattern during at least the preceding month before screening.

• Self reported history of disturbed sleep on at least 3 nights per week for at least the last 1 month before screening.

  • ≥30 min to fall asleep
  • ≥30 min awake during sleep time
  • Self-reported total sleep time of ≤ 6.5 h

• ISI total score ≥ 10

• Confirmation of presence of insomnia diagnosis according to the ICD-10 F51.0/ICD-11 7A00 criteria by the physician upon anamnesis.

• Reported Impact on daytime functioning associated with sleep maintenance as measured with question 7 of the ISI, Score >= 2

• Freezing capacities available for storage of saliva samples.

• Willingness and infrastructure available to run aktigraphic device (bed sensor) properly

Exclusion criteria

• Body mass index (BMI) <18.0 or >30.0 kg/m2.
• 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.
• Any known acute organic disorder affecting sleep quality, such as narcolepsy, obstructive sleep apnea (OSA), restless leg syndrome (RLS), periodic limb movement syndrome (PLMS), circadian rhythm disorder, rapid-eye-movement behavior disorder, benign prostatic hyperplasia (BPH), urinary tract infections, irritated bladder, acute and/or chronic pain.
• Any known acute or chronic psychiatric condition (e.g., severe mono- or bipolar depression, history of suicidal ideation or attempt, severe anxiety disorders, severe personality disorders, borderline personality disorder, psychoses).
• 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, and dementia).
• History of alcohol or drug misuse
• Regular alcohol consumption exceeding 140g/week, heavy smoking (>10 cigarettes/day), high caffeine intake (>10 glasses/day).
• Current 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).
• Have a clinically significant high/low blood pressure (systolic over 159 mmHg, resp. lower than 80 mmHg or diastolic over 99 mmHg, resp. lower than 60 mmHg).
• History or planned travel to a different time zone within 1 month of the first visit or/and during the study participation.
• Shift-worker.
• Not fluent in local language.
• 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).
• Participation in another study with any investigational product within 30 days of screening and during the intervention period.
• Investigator believes that the subject may be uncooperative and/or noncompliant and should therefore not participate in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

100 participants in 2 patient groups, including a placebo group

Verum Group: Eschscholzia tablets

Experimental group

Description:

One Escholzia tablet (1.0 g) contains as active pharmaceutical ingredient: 0.503 g Eschscholzia californica Herba rec. tinct. conc. as the active pharmaceutical ingredient (API) corresponding 600 mg powdered herbal material.

Treatment:

Drug: Eschscholzia tablets

Control Group: Placebo tablets

Placebo Comparator group

Description:

A placebo tablet will be provided that matches the verum in its optical and sensorial properties and posology. Contains: microcrystalline cellulose, Colloidal anhydrous silica, glycerol distearate, caramel couleur and colorants.

Treatment:

Drug: Placebo Tablets