Primary (psychophysiologic) insomnia MedDRA version: 13.1 Level: LLT Classification code 10036701 Term: Primary insomnia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Nervenruh Baldrian forte 600
Pharmaceutical Form: Coated tablet
INN or Proposed INN: valerian root dry extract
CAS Number: 8057-49-6
Other descriptive name: VALERIANA OFFICINALIS L. RADIX
Sponsors
MCM Klosterfrau GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female patients, aged 18-60 years - Written informed consent of the patients - Sleep onset latency value between 15 min and 45 min (Polysomnographic evaluation) - Total sleep time value between 3 h and 7 h (Polysomnographic evaluation) - Current diagnosis of primary insomnia using ICSD-2 criteria Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Secondary insomnia criteria - Serious diseases which preclude a patient’s participation in the investigator’s opinion - Pregnancy or breast-feeding. Premenopausal women must use an approved birth control method. - Any current diagnosis of alcohol or substance abuse/dependence (with the exception of cigarette smoking) - Regular (= 4 times per week for at least 4 weeks) intake of sedatives / hypnotics / antihistamines, sedating antidepressants and beta-blockers (abstinence time: 7 days prior to PSG screening night) - Known sensitivity to the ingredients of the IMP - Simultaneous participation in another clinical trial or participation in a clinical trial during 6 weeks before start of this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this open label clinical trial is to investigate the physiological effects on sleep after daily administration (14 days) of the IMP to patients with primary insomnia. The hypothesis is that the IMP has positive effects on certain PSG parameters thus improving the sleep quality of patients.;Secondary Objective: The secondary objectives of this clinical trial are: - To investigate the changes in the percentages of sleep stages W, N1, N2, N3, and R on the total sleep time (TST) after 14-days administration of the IMP. - To asses and analyze the subjective sleep quality of patients using validated questionnaires and psychometric tests (Insomnia Severity Index (ISI), VIS-A/VIS-M (as a diary), “attention stress test” (d2-R)) during the trial. - To evaluate the global clinical effect and tolerability of the IMP by the investigator and the patients. ;Primary end point(s): Change (baseline vs. end of trial) in sleep onset latency (SOL), total sleep time (TST) and sleep efficiency (SE).;Timepoint(s) of evaluation of this end point: Baseline (visit 1) and end of trial (visit 3) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in: - the percentages of sleep stages W, N1, N2, N3, and R on the total sleep time (TST) - the subjective sleep quality of patients using questionnaires and psychometric tests: - Insomnia Severity Index (ISI) - VIS-A/VIS-M - Test d2-R;Timepoint(s) of evaluation of this end point: Baseline (visit 1) and end of trial (visit 3) | — |
Countries
Germany
Contacts
Public ContactMedical Science Division
MCM Klosterfrau GmbH & Co. KG
Outcome results
None listed