Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
750201.01.025
Study information
Scientific title
Exploratory study to assess the cerebral bioavailability of Silexan® WS® 1265 standard softgel capsule and Silexan® WS® 1265 enteric-coated capsule using quantitative Electroencephalography (EEG) in healthy volunteers: a single-centre, randomised, double-blind, placebo-controlled, crossover study
Acronym
Silexan® (WS® 1265): EEG
Study hypothesis
To assess the influence of Silexan® (Silexan WS® 1265 standard softgel capsule part 1 and Silexan® WS® 1265 enteric-coated capsule part 2) on electric power of six defined frequency ranges with respect to 17 electrode positions during pharmaco electroencephalography in combination with psychometry. Investigation of bioavailability of Silexan® to the brain.
Ethics approval
Ethics Committee at the State Medical Board of Hessen (Ethik-Kommission bei der Landesärztekammer Hessen) approved on 8th February 2011
Study design
Single-centre randomised double-blind placebo-controlled crossover study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Anxiety disorder
Intervention
Cross-over with 3 sequences and 3 periods (part1: Silexan® WS® 1265 standard softgel capsule 80mg, 160mg , placebo; part2: Silexan® WS® 1265 enteric-coated capsule: 80mg, 160mg, placebo).
Each sequence for 14 days; one capsule once a day.
First administration at day 1 of each sequence before EEG sessions every hour until 4 hours after administation; then drugs are dispensed for the following 14 days.
Intervention type
Drug
Phase
Not Applicable
Drug names
Silexan® (Silexan WS® 1265 standard softgel capsule , Silexan® WS® 1265 enteric-coated capsule
Primary outcome measure
Outcome variables describing the bio-availability of Silexan® to the brain
1. Quantitative source density EEG: electric power (V2) within the six frequency ranges (delta, theta, alpha1, alpha2, beta1 and beta2) for each of the 17 electrode positions (102 variables). The variables are assessed for recording condition "eyes open" and "eyes closed" separately. Electrode positions from two different brain regions of interest (ROI) (fronto-temporal delta and theta power and centro-parietal alpha1,2 and beta1,2 power) are grouped and averaged together to give a total of six parameters (one for each frequency) for the recording condition of three challenges: performance of the d2-test, the concentration performance test CPT (under stress) and the memory test. Thus, 18 parameters will be assessed for the recordings during mental challenges. All parameters are assessed 1 - 4 hours after administration as difference to absolute power of pre-drug values (which are set to 100%).
2. Outcome variables of psychometry
2.1. Attention-Load-Test (d2-Test)
2.2. Concentration-Performance-Test (CPT)
2.3. Memory Test (ME)
3. Outcome variables of safety
3.1. Adverse events
3.2. Laboratory tests
Secondary outcome measures
No secondary outcome measures
Overall trial start date
28/02/2011
Overall trial end date
30/10/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male or female outpatients aged 18 to 65 years (both inclusive)
2. Written informed consent in accordance with the legal requirement
3. Readiness and ability on the part of the patient to comply with the physicians instructions and to fill in the self-assessment scales
4. Negative pregnancy test within 7 days before baseline visit in women with childbearing potential (non-childbearing potential is defined as post-menopause for at least one year or surgical sterilisation or hysterectomy at least three months before the study starts)
5. Use of adequate double contraception in women with childbearing potential [oral or injectable contraception or hormonal intra-uterine system (IUS) combined with condom]
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
2 x 24 healthy volunteers (3 sequences, each with 8 subjects in both parts).
Participant exclusion criteria
1. Participation in another clinical trial during the preceding 3 months
2. Pregnancy, lactation
3. Any acute medical disorder
4. History of relevant diseases of vital organs, of the central nervous system or other organs
5. Gastrointestinal disorders with uncertain absorption of orally administered drugs (e.g. partial or total gastrectomy, enterectomy, inflammatory bowel disease, celiac disease, symptomatic lactose intolerance, other disorders associated with chronic diarrhoea)
6. Subjects with a medical disorder, condition or history of such that would impair the subjects ability to participate or complete this study in the opinion of the investigator or the sponsor
7. Known hypersensitivity to lavender preparations
8. Regular daily consumption of more than 25 cigarettes
9. Regular daily consumption of more than half litre of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form
10. Regular daily consumption of more than one litre of xanthin-containing beverages
11. Use of medication within the 2 weeks preceding the study which could interfere with the investigational product
12. Prohibited concomitant medication
13. Relevant deviation from the normal range in clinical chemistry, haematology or urinalysis
14. Resting heart rate in the awake subject below 45 beats per minute (BPM) or above 100 BPM
15. Systolic blood pressure below 90 mmHg for women and below 100 mmHg for men or above 150 mmHg
16. Diastolic blood pressure above 95 mmHg
17. History or evidence of alcohol and/or substance abuse or dependence, particularly of sedatives, hypnotics and anxiolytics within last 6 months before the study
18. Subjects testing positive in the drug screening
19. Participation in any previous clinical study with Silexan®/Lavender oil WS1265 or participation in a further clinical trial at the same time
20. Massive deviation from normal quantitativee electroencephalography (EEG) parameters
Recruitment start date
28/02/2011
Recruitment end date
30/10/2011
Locations
Countries of recruitment
Germany
Trial participating centre
NeuroCode AG
Wetzlar
35578
Germany
Funders
Funder type
Industry
Funder name
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list