Efficacy and Safety of Eschscholtzia Californica in Treating Primary Insomnia

Sleep Initiation and Maintenance Disorders Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02183233
• Other study ID #: 1120.2
• Status: Terminated
• Phase: Phase 3
• First received: July 4, 2014
• Last updated: July 4, 2014
• Start date: January 1998

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 49
• Est. primary completion date: June 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Eschscholtzia Californica

• Eschscholtzia Californica Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in sleep latency		Days 0, 7, 14 and 28	No
Secondary	Change from baseline in sleep duration		Days 0, 7, 14 and 28	No
Secondary	Change from baseline in number of awakenings		Days 0, 7, 14 and 28	No
Secondary	Change from baseline in quality of sleep		Days 0, 7, 14 and 28	No
Secondary	Change from baseline in presence of morning sleepiness		Days 0, 7, 14 and 28	No
Secondary	Change from baseline in morning concentration ability		Days 0, 7, 14 and 28	No
Secondary	Change from baseline in Clinical Global Impression (CGI) score		Days 0, 7, 14 and 28	No
Secondary	Change from baseline in quality of life (QL questionnaire SF-23)		Days 0, 7, 14 and 28	No
Secondary	Number of patients with adverse events		up to 28 days	No

External Links

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