Efficacy and Safety of Eschscholtzia Californica in Treating Primary Insomnia

A Double-blind Randomized, Placebo Controlled Study to Assess the Efficacy and the Safety of Eschscholtzia Californica 1000 mg Per Day in Treating Primary Insomnia During a 28 Day Treatment Duration.

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.

Study Overview

• Status: Terminated
• Conditions: Sleep Initiation and Maintenance Disorders
• Intervention / Treatment: Drug: Eschscholtzia Californica; Drug: Eschscholtzia Californica Placebo

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Eschscholtzia Californica	Drug: Eschscholtzia Californica
PLACEBO_COMPARATOR: Eschscholtzia Californica Placebo	Drug: Eschscholtzia Californica Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in sleep latency	Days 0, 7, 14 and 28

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients with adverse events	up to 28 days
Change from baseline in sleep duration	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
Change from baseline in morning concentration ability	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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 1998
• Primary Completion (ACTUAL): June 1, 1998

Study Registration Dates

• First Submitted: July 4, 2014
• First Submitted That Met QC Criteria: July 4, 2014
• First Posted (ESTIMATE): July 8, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): July 8, 2014
• Last Update Submitted That Met QC Criteria: July 4, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 1120.2