Driving fitness under Silexan compared to placebo and lorazepam
- Conditions
- Driving fitnessNot Applicable
- Registration Number
- ISRCTN32209377
- Lead Sponsor
- Dr. Willmar Schwabe GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 201
1. Aged 25 to 60 years
2. Active drivers that have had a driver’s license for at least 3 years and have a minimal mileage per year of 3000 km
3. Written informed consent
4. Only for female volunteers who have not entered menopause and who are not sterilized: Using a highly effective method of birth control that has a very low failure rate
1. Participation in another clinical trial at the same time or within the past 4 weeks before enrolment
2. Acute illness and/or infections and/or fever within the past 7 days prior to administration of IMP
3. Increased intraocular pressure
4. Chronic illness
5. Gastrointestinal disorders with uncertain absorption of orally administered drugs
6. < 3 months before inclusion of the participant: use of psychoactive substances
7. < 2 weeks before inclusion of the participant: use of centrally acting drugs
8. < 3 months before inclusion of the participant: use of recreational drugs, e.g. CNS stimulants like amphetamines, cannabis, cocaine and others
9. History or evidence of alcohol or drug abuse/dependence
10. Positive result in the drug screening or in the alcohol breath test at screening visit
11. Presence or history of clinically relevant allergy or a known or suspected hypersensitivity to lavender oil, Lorazepam and/or excipients of the IMP or benzodiazepines
12. Any clinically relevant laboratory value which the investigator decides might affect the study objectives
13. Females who are breastfeeding or who are pregnant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method