E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
healthy volunteers (medicine for acute unilateral vertigo) |
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E.1.1.1 | Medical condition in easily understood language |
healthy subjects (medicine for acute vertigo/motion sickness) |
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E.1.1.2 | Therapeutic area | Body processes [G] - Physical Phenomena [G01] |
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 |
Primary Objective: • To confirm the absence of sedative effects and therefore the maintenance of vigilance with SENS-111 in subjects exposed to a vestibular conflict
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E.2.2 | Secondary objectives of the trial |
Secondary Objectives: • To confirm the pharmacodynamic effects of SENS-111 on symptoms experimentally induced by motion. • To assess the safety of SENS-111
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male 2. Aged ≥18 years and ≤ 45 years 3. Susceptible to motion sickness defined as MSSQ–short within 10th to 90th percentiles 4. Signed and dated written informed consent.
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E.4 | Principal exclusion criteria |
1. History of acute or chronic vestibular disorder, tinnitus or hearing loss, or inner ear problem 2. Past history of seizures or convulsions 3. Past history of migraine or hyperemesis 4. Subjects with known allergy to meclizine, or to any other histamine antagonist 5. Known severe adverse drug reaction e.g. clinical symptoms of cardiac rhythm disturbances 6. Subjects with known asthma 7. History of alcohol or drug abuse 8. Current participation in another clinical trial 9. Treatment with any investigational agent within 4 weeks prior to randomization or 5 half-lives of the investigational drug (whichever is longer) 10. Subject with known narrow angle glaucoma, 11. Subject with known prostate enlargement or history of urine retention 12. Subject with infection or inflammatory process during screening or at inclusion 13. Positive urine screening for drugs 14. Any abnormality on 12-lead electrocardiogram (ECG), in particular QTc prolongation defined by: QTc >470 ms 15. Clinically significant abnormal blood pressure (>140/90 mmHg) or significant abnormal heart rate (arrhythmia,or tachycardia or bradycardia). 16. Known history of, or concomitant hepatic, gastrointestinal, cardiovascular, respiratory, neurological, psychiatric, hematological, renal, or dermatological disease, or any condition, psychiatric, substance abuse, or otherwise, that, in the opinion of the Investigator might interfere with the evaluation of study treatment or warrant exclusion. 17. Abnormal laboratory findings: a. Creatininemia >1.5 upper limit of normal (ULN)) b. ALAT and/or ASAT > 1.5 x ULN c. Hemoglobin 10 g/ml and/or d. Neutrophils <1500/ml and/or e. Platelets <100 000 /ml 18. Subject is unavailable to complete the study (including all follow-up visits) and comply with study restrictions. 19. Subjects who, in the opinion of the Investigator, have significant medical or psychosocial findings that warrant exclusion. Examples of significant problems include, but are not limited to other serious non-malignancy-associated medical conditions that may be expected to limit life expectancy or significantly increase the risk of SAEs and any condition, psychiatric, substance abuse, or otherwise, that, in the opinion of the Investigator, would preclude informed consent, consistent follow-up, or compliance with any aspect of the study 20. Subject is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol. 21. Any treatment within 72 hours prior to inclusion 22. Prior participation in a clinical trial with SENS-111
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoints reflecting sedation will be assessed by the change of performance over time, compared to baseline, including all test parameters of the • Pepsy psychomotor test battery; • Vigilance & Tracking test.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
baseline T=-0:45 before drug intake assessment 1 T=+1:30 after drug intake assessment 2 T=+2:45 after drug intake assessment 3 T=+4:00 after drug intake assessment 4 T=+5:00 after drug intake |
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E.5.2 | Secondary end point(s) |
The main secondary endpoints reflecting sedation will be assessed by the change over time, compared to baseline, of • the diameter of the pupil measured by static pupillometry test; • subjective alertness measured by the Stanford Sleepiness Scale. The main secondary endpoint reflecting efficacy will be assessed by the severity of nausea and associated symptoms assessed by the MISC during the rotary chair run and by the change over time, compared to baseline. Another secondary endpoint reflecting efficacy will be assessed by the change over time, compared to baseline, of balance performance as measured by the Balance Test.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
baseline T=-0:45 before drug intake assessment 1 T=1:30 after drug intake assessment 2 T=2:45 after drug intake assessment 3 T=4:00 after drug intake assessment 4 T=5:00 after drug intake
For the MISC: during the run on the rotation chair, they will fill in the MISC at 2 minute intervals. |
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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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
E.8.7 | Trial has a data monitoring committee | No |
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 end of study visit will include a standard laboratory blood test (within 2 weeks), and a phone call to inquire about adverse events. |
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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 | |
E.8.9.1 | In the Member State concerned days | |