Efficacy and Safety of Eschscholtzia Californica in Treating Primary Insomnia

Boehringer Ingelheim

Status and phase: Terminated; Phase 3

Conditions: Sleep Initiation and Maintenance Disorders

Treatments: Drug: Eschscholtzia Californica Placebo; Drug: Eschscholtzia Californica

Study type: Interventional

Funder types: Industry

Identifiers

NCT02183233

1120.2

Details and patient eligibility

About

The aim of this trial was to assess the efficacy and safety of Eschscholtzia Californica (EC) in treating patients having psycho-physiologic insomnia in a double-blind randomised placebo controlled trial during a 28-day treatment duration.

Enrollment: 49 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female above 18 or below 65 years old
• Diagnosis of psycho-physiologic insomnia, according to the criteria of DSM-IV (Diagnostic and Statistical manual - Version IV)
• Written informed consent

Exclusion criteria

• Patient who is already taking other investigational drugs or who has taken part in another trial during the past three months

• Patient who has an history of psychiatric diseases, such as:

  • anxiety disorders; the score of the HAMA (Hamilton anxiety scale) must be < 10
  • depression according to the DSM IV criteria; the score of the HAMD (Hamilton depression scale) must be < 10
  • mania
  • schizophrenia
  • dementia

• Patient who has an history of neurologic diseases, such as:

  • Parkinson syndrome
  • crania cerebral trauma post syndrome
  • brain tumor
  • fibromyalgia

• Patient who has an history of an iatrogenic insomnia, due to drugs like antidepressor, neuroleptic or benzodiazepine, hypnotic

• Patient with an hypersomnia or a sleep apnea syndrome

• Patient with any pathology inducing a chronic pain, a pyrosis, a nocturnal pollakiuria, a dyspnea

• Patient with a Restless Leg Syndrome

• Patient with severe hepatic or renal insufficiency which judged to be regarded as clinically relevant by the investigator, or any known clinically significant disease which may induce a risk for the patient in participating to the trial

• Breast feeding or pregnant female, or female with no efficient contraception method

• Patient with non-stabilised thyroid dysfunction

• Patient with a known allergy to Eschscholtzia Californica or its compounds

• Patient with alcohol or drug dependency

• Patient drinking tea, coffee or Coca-Cola after 4 p.m.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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49 participants in 2 patient groups, including a placebo group

Eschscholtzia Californica

Experimental group

Treatment:

Drug: Eschscholtzia Californica

Eschscholtzia Californica Placebo

Placebo Comparator group

Treatment:

Drug: Eschscholtzia Californica Placebo