E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This study will evaluate the impact of betahistine on motion sickness. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027990 |
E.1.2 | Term | Motion sickness |
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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 |
To assess the effect of betahistine on the severity / intensity of motion sickness |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age 18-30 years at Day 01 of the study Female volunteers should take oral contraceptives (combined or progestogen only). This is to attenuate hormonal influences on the susceptibility to motion sickness. The menstrual cycle has been shown to influence motion sickness susceptibility (Golding et al. 2004). Body Mass Index (BMI) 18-28 kg/m2 Healthy as assessed by health questionnaire (Pbetahistine F02; in Dutch) and a physical examination limited to auscultation of heart and lung, blood pressure and heart rate Susceptibility to motion sickness is more than 35 on Golding’s MSSQ scale. Participation on a voluntary basis Having given their written informed consent Willing to comply with the study procedures (e.g. the possible provocation of motion sickness) Willing to accept use of all anonymous data, including publication, and the confidential use and storage of all data Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned
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E.4 | Principal exclusion criteria |
Participation in any clinical trial including blood sampling and/or administration of substances up to 30 days before Day 01 of this study Having a history of medical or surgical events that may significantly affect the study outcome as vestibular, cardiovascular, pulmonary, gastrointestinal, neurological, psychiatric, hepatic, renal, hematological or other organic abnormality or pathology, including: asthma, ulcus pepticum urticaria, or allergic complaints as a rash or allergic rhinitis). Prescribed medication that may interfere with the study outcome Inclination to hyperventilation (Nijmegen questionnaire score > 23) Not able to undergo the familiarization tests inside the moving base-simulator Desdemona (see below) Alcohol consumption females > 21 or units/week; males >28 units/week Pregnancy or breastfeeding TNO personnel and their close relatives Not having a general practitioner Not willing to accept information-transfer concerning participation in the study, or information regarding his/her health, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner |
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E.5 End points |
E.5.1 | Primary end point(s) |
It is expected that betahistine will diminish motion sickness. In both conditions of the experiment subjects will be exposed to the same motion stimulus. This stimulus will last for half an hour, or less if a certain motion sickness level (‘’moderate nausea’’), indicated by the subject, is reached prior to the end of the 30 min period. The exposure duration is the main study parameter. The tests at the intake have a dual goal: to determine the participants’ motion sickness susceptibility level, and to determine which motion stimulus is provocative enough to induce motion sickness within 30 minutes, but not within a few minutes. For this test, a motion sickness inducing stimulus will be chosen that does not invoke hyperventilation. To this effect the breathing of the subjects is analysed during the tests so that hyperventilation can be excluded. |
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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 | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | Information not present in EudraCT |
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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Last visit of the last subject is the end of the trial |
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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 | 15 |
E.8.9.2 | In all countries concerned by the trial days | 15 |