E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy Volunteers (Migraine) |
Gezonde vijwilligers (Migraine) |
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E.1.1.1 | Medical condition in easily understood language |
Healthy volunteers (Migraine) |
Gezonde vrijwilligers (Migraine) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10027599 |
E.1.2 | Term | Migraine |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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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 |
Investigate the effect of propranolol and placebo on the rise of dermal blood flow caused by capsaicin application and iontophoresis of normal saline. |
Onderzoek naar het effect van propranolol en placebo op de toename in huiddoorbloeding veroorzaakt door applicatie van capsaicine en iontoforese van fysiologisch zout oplossing. |
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E.2.2 | Secondary objectives of the trial |
Study the relationship between the effect of propranolol on trigeminovascular dermal blood flow and blood pressure. |
Onderzoek naar de relatie tussen het effect van propranolol op trigeminovasculaire huiddoorbloeding en bloeddruk. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age between 18 and 64 years Females should be using oral contraceptives or Mirena Non-smoking for > 6 months Body mass index between 19 and 28 kg/m^2 Capable and willing to give informed consent General good health, based on medical history and physical examination |
Leeftijd tussen de 18 en 64 jaar Vrouwen moeten gebruik maken van orale anticonceptie (de pil) of de Mirena > 6 maanden niet roken Body mass index tussen de 19 en 28 kg/m^2 Bereid om schriftelijke toestemming te geven Algemeen goede gezondheid, gebaseerd op medische voorgeschiedenis en lichamelijk onderzoek |
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E.4 | Principal exclusion criteria |
History of cardiovascular disease History of migraine History of asthma and/or previous use of bronchodilators Blood pressure <110 systolic (sitting) Heart rate <60 bpm Any serious illness that can compromise study participation Use of any medication (e.g., NSAIDs, other analgesics) < 48 hrs before the study Dermal diseases at the upper frontal side of the face Pregnancy or breastfeeding History of sensitivity to the fruits of capsicum plants (e.g. chilli peppers) Alcohol or drug abuse |
Geschiedenis van hart-en vaatziekten Geschiedenis van migraine Geen geschiedenis hebben met astma en/of het gebruik van luchtwegverwijders Bloeddruk <110 systolisch (zittend) Hartslag <60spm Elke ernstige ziekte die de participatie aan de studie in de weg kan staan Gebruik van medicijnen (bijv. NSAID's, andere pijnstillers) Dermale ziekten aan de boven voorkant van het gezicht Zwangerschap of geven van borstvoeding Geschiedenis van gevoeligheid voor vruchten van capsicum planten (bijv. rode pepers) Alcohol-of drugsmisbruik |
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E.5 End points |
E.5.1 | Primary end point(s) |
Changes in dermal blood flow response to capsaicin application and saline iontophoresis, after propranolol or placebo administration. |
Veranderingen in huiddoorbloeding respons op capsaicine applicatie en iontoforese van fysiologische zout oplossing, na het toedienen van propranolol of placebo. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Heat sensation after capsaicin application Blood pressure changes after propranolol use |
Warmte sensatie na capsaicine applicatie Bloeddruk verandering na propranolol |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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 | 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.8.2.4 | Number of treatment arms in the trial | 2 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |