healthy volunteers (medicine for acute unilateral vertigo)
Conditions
Interventions
Trade Name: Suprimal (Meclizine)
Product Name: Suprimal Tablets 12,5 mg
Product Code: n/a
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo
Sponsors
Sensorion
Eligibility
Sex/Gender
Male
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 32 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 ;Secondary Objective: Secondary Objectives: • To confirm the pharmacodynamic effects of SENS-111 on symptoms experimentally induced by motion. • To assess the safety of SENS-111 ;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. ;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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. ;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. | — |
Countries
Netherlands
Contacts
Public ContactSenior Clinical Research Associate
Sensorion
Outcome results
None listed