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
| ISRCTN | ISRCTN35823260 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35823260 |
| Secondary identifying numbers | 750201.01.025 |
- Submission date
- 08/02/2011
- Registration date
- 18/03/2011
- Last edited
- 18/03/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Winfried Wedekind
Scientific
Scientific
NeuroCode AG
Sportparkstr. 9
Wetzlar
35578
Germany
Study information
| Study design | Single-centre randomised double-blind placebo-controlled crossover study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| 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 |
| Study acronym | Silexan® (WS® 1265): EEG |
| Study objectives | 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(s) | Ethics Committee at the State Medical Board of Hessen (Ethik-Kommission bei der Landesärztekammer Hessen) approved on 8th February 2011 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 28/02/2011 |
| Completion date | 30/10/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 2 x 24 healthy volunteers (3 sequences, each with 8 subjects in both parts). |
| Key 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] |
| Key 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 |
| Date of first enrolment | 28/02/2011 |
| Date of final enrolment | 30/10/2011 |
Locations
Countries of recruitment
- Germany
Study participating centre
NeuroCode AG
Wetzlar
35578
Germany
35578
Germany
Sponsor information
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Industry
Industry
Dr. Willmar Schwabe Strasse 4
Karlsruhe
76227
Germany
"ROR" |
https://ror.org/043rrkc78 |
|---|
Funders
Funder type
Industry
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
