Efficacy and Safety of Eschscholtzia Californica in Treating Primary Insomnia

Phase 3

Terminated

• Conditions: Sleep Initiation and Maintenance Disorders
• Interventions: Drug: Eschscholtzia Californica; Drug: Eschscholtzia Californica Placebo

• Registration Number: NCT02183233
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-01
• Primary Completion: 1998-06
• Status Verified: 2014-07
• Study First Submitted: 2014-07-04
• Study First Submitted QC: 2014-07-04
• Last Update Submitted: 2014-07-04
• Study First Posted: 2014-07-08
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 49

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eschscholtzia Californica	Eschscholtzia Californica	-
Eschscholtzia Californica Placebo	Eschscholtzia Californica Placebo	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in sleep latency	Days 0, 7, 14 and 28

Secondary Outcome Measures

Name	Time	Method
Number of patients with adverse events	up to 28 days
Change from baseline in morning concentration ability	Days 0, 7, 14 and 28
Change from baseline in sleep duration	Days 0, 7, 14 and 28
Change from baseline in Clinical Global Impression (CGI) score	Days 0, 7, 14 and 28
Change from baseline in quality of life (QL questionnaire SF-23)	Days 0, 7, 14 and 28
Change from baseline in number of awakenings	Days 0, 7, 14 and 28
Change from baseline in quality of sleep	Days 0, 7, 14 and 28
Change from baseline in presence of morning sleepiness	Days 0, 7, 14 and 28