Clinical trial NCT02183233: Efficacy and Safety of Eschscholtzia Californica in Treating Primary Insomnia
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Sleep Initiation and Maintenance Disorders
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-08
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in sleep latency
timeFrame: Days 0, 7, 14 and 28
Secondary outcomes:
measure: Change from baseline in sleep duration
timeFrame: Days 0, 7, 14 and 28
measure: Change from baseline in number of awakenings
timeFrame: Days 0, 7, 14 and 28
measure: Change from baseline in quality of sleep
timeFrame: Days 0, 7, 14 and 28
measure: Change from baseline in presence of morning sleepiness
timeFrame: Days 0, 7, 14 and 28
measure: Change from baseline in morning concentration ability
timeFrame: Days 0, 7, 14 and 28
measure: Change from baseline in Clinical Global Impression (CGI) score
timeFrame: Days 0, 7, 14 and 28
measure: Change from baseline in quality of life (QL questionnaire SF-23)
timeFrame: Days 0, 7, 14 and 28
measure: Number of patients with adverse events
timeFrame: up to 28 days
Other outcomes:
Locations:
Study officials:
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