restlessness and sleep disturbances MedDRA Code for RESTLESSNESS: 10038743 MedDRA Code für SLEEP DISTURBANCES: 10040997
Conditions
Interventions
Product Name: Lavendelöl WS 1265
Pharmaceutical Form: Capsule*
INN or Proposed INN: Lavender oil Ph. Eur.
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 80-
Pharma
Sponsors
Dr. Willmar Schwabe GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Present restlessness and sleep disorders. 2. Age: 18 to 65 years. 3. Out-patient treatment by a general practitioner or specialized physician. 4. Severity of anxiety and restlessness symptoms for the inclusion in the wash-out and into the acute treatment phase: HAM-A total score more or equal than 18 and Item 2 „tension“ more or equal than 2 and Item 4 „insomnia“ more or equal than 2. These criteria have to be met at Visits 1 and 2. 5. Severity of sleep disorders for the inclusion in the wash-out and into the acute treatment phase: PSQI total score more or equal than 6. This criterion has to be met at Visits 1 and 2. 6. Written informed consent in accordance with the legal requirement. 7. Readiness and ability on the part of the patient to comply with the physician´s instructions and to fill in the self-assessment scales. 8. Negative pregnancy test within 5 days before study start in females of childbearing potential (non-childbearing potential is defined as post-menopause for at least one year or surgical sterilization or hysterectomy at least three months before study start). 9. Use of adequate contraception by female with childbearing potential (intra-uterine devices, oral or injectable contraception). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. A decrease of 25% or more of the HAM-A total score during the screening phase. 2. Any clinically important psychiatric or neurological diagnose within 6 month before the study, except anxiety disorders, mild to moderate unipolare depressive disorders, somatoform disorders, neurasthenia, personality disorders, primary insomnia. 3. Risk of suicide. 4. History or evidence of alcohol and/or substance abuse or dependence, particularly of sedatives, hypnotics and anxiolytics. (303.90; 305.00; 304.10; 305.40) 5. Shizophrenia. 6. Current use of other psychotropic drugs within 30 days of baseline visit.* 7. History of hypersensitivity to Lavender preparations. 8. Any unstable acute medical disorder. 9. Unacceptability to discontinue, or likelihood to need medication during the study that is prohibited as concomitant treatment (specified in section 6). The following medication is not allowed during the study: - any psychotropic drugs including benzodiazepines, non-benzodiazepines (zopiclone, zolpidem), neuroleptics, tranquilizer, antidepressives, antiepileptics, antihistaminics - long-term prophylactic treatment (e.g. lithium, carbamazepine) - central-acting antihypertensive medication - antiparkinson medication - phyto-anxiolythics - muscle relaxants - analgetics of opiate type - anesthetics - barbiturates - nootropics. 10. Non-medical psychiatric treatment (e.g., specific standardized psychotherapy) during the course of the study. 11. Treatment with any other investigational drug in the last 12 weeks before screening. 12. Clinical significant abnormality of ECG and/or laboratory value(s). 13. Any abnormal baseline finding considered by the investigator to be indicative of conditions that might affect study results. 14. Pregnancy, lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To prove the clinical efficacy of Lavender oil WS 1265 in the treatment of patients with restlessness and sleep disorders;Secondary Objective: To compare Lavender oil WS 1265 and placebo in responder rates whereby responders are defined as: - At least 50% reduction of the HAM-A total score between baseline and week 10 or 25% reduction of the PSQI total score between baseline and week 10; - Total score of the HAM-A below 10 points at week 10 or total score of the PSQI below 6 points at week 10. ;Primary end point(s): - change of HAM-A total score between baseline and week 10; - change of PSQI total score between baseline and week 10. (protocol section 12.2) | — |
Countries
Germany
Outcome results
None listed