E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
restlessness and sleep disturbances
MedDRA Code for RESTLESSNESS: 10038743 MedDRA Code für SLEEP DISTURBANCES: 10040997 |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To prove the clinical efficacy of Lavender oil WS 1265 in the treatment of patients with restlessness and sleep disorders |
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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).
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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the last visit of the last subject
(see also protocol sections 10.1 - 10.3) |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |