E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
To study whether there is a difference in treatment effect between oxygen at flow rates of 7 L/min versus 12 L/min in the acute treatment of cluster headache attacks. |
Bestudering of er een verschil is in pijnstillend effect tussen zuurstof gegeven met een stroomsnelheid van 7 L/min versus 12 L/min bij de acute behandeling van clusterhoofdpijn aanvallen. |
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E.1.1.1 | Medical condition in easily understood language |
To study whether there is a difference in treatment effect between oxygen at flow rates of 7 L/min versus 12 L/min in the acute treatment of cluster headache attacks. |
Bestudering of er een verschil is in pijnstillend effect tussen zuurstof gegeven met een stroomsnelheid van 7 L/min versus 12 L/min bij de acute behandeling van clusterhoofdpijn aanvallen. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
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 |
To study whether there is a difference in treatment effect between oxygen at flow rates of 7 L/min versus 12 L/min in the acute treatment of cluster headache attacks. |
Bestudering of er een verschil is in pijnstillend effect tussen zuurstof gegeven met een stroomsnelheid van 7 L/min versus 12 L/min bij de acute behandeling van clusterhoofdpijn aanvallen. |
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E.2.2 | Secondary objectives of the trial |
- Identifying subgroups in which oxygen at flow rates of 7 L/min or 12 L/min is more effective.
- To determine whether the rebound effect known to occur in oxygen treatment is more frequently observed in one of the different flow rates or whether this is an effect independent from the flow rates used.
- To note any potential side-effects of oxygen treatment, and if observed, determine if they occur more in either 7 L/min or 12 L/min.
- To determine if the efficacy of oxygen treatment stays constant after several treated attacks.
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- Patiënten karakteristieken onderscheiden die het effect van verschillende zuurstof stroomsnelheden kunnen voorspellen. Dit zou de neuroloog kunnen helpen om te bepalen bij welke patiënten 12 liter per minuut en bij welke 7 liter per minuut de voorkeur heeft;
- Bepaling of het rebound effect bij zuurstoftherapie meer voorkomt bij een van de zuurstof stroomsnelheden;
- Bepaling van mogelijke bijwerkingen van zuurstoftherapie en of deze vaker voorkomen bij een stroomsnelheid van 7 liter per minuut of 12 liter per minuut;
- Bepaling of de effectiviteit van zuurstoftherapie gelijk blijft na de behandeling van meerdere clusterhoofdpijn aanvallen. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All newly diagnosed cluster headache patients of at least 18 years of age and known cluster headache patients of at least 18 years of age who are naïve to oxygen treatment. |
Clusterhoofdpijn patiënten van 18 jaar en ouder die nog niet eerder zuurstof gebruikten. |
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E.4 | Principal exclusion criteria |
- All patients who used oxygen in the past.
- Pregnancy or lactation.
- COPD and other contraindications for oxygen therapy, as determined by the patients’ physicians.
- Secondary cluster headache. Patients might be included before imaging is conducted. If so, they will be excluded afterwards when they are diagnosed as secondary cluster headache.
- Other primary or secondary headache diagnoses or other distracting painful conditions which could interfere with the patient’s pain perception.
- Incapacitation to understand and sign for informed consent.
- Patients living outside a designated insurance zone, as costs of the adapted oxygen tanks will not be covered elsewhere.
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- Alle patiënten die in het verleden zuurstof gebruikten.
- Zwangerschap of geven van borstvoeding.
- COPD en andere contraïndicaties voor zuurstofbehandeling, zoals vastgesteld door de behandelend arts van de patiënt.
- Secundaire clusterhoofdpijn.
- Andere primaire of secundaire hoofdpijn diagnosen of andere pijnlijke aandoeningen die kunnen interfereren met de pijnperceptie van de patiënt.
- Onmogelijkheid om het informed consent te begrijpen en hiervoor te tekenen.
- Patiënten die buiten de aangegeven verzekeringszone wonen. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The main end point of the study will be the difference in VAS-scores before and after treatment. |
Primaire uitkomstmaat is verschil in VAS-score voor en na zuurstofbehandeling.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
15 minutes after start of oxygen treatment |
15 minuten na start van zuurstofbehandeling |
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E.5.2 | Secondary end point(s) |
The secondary endpoint will be the percentage of attacks treated successfully. An attack treated successfully is defined as achievement of a painfree state or as a drop in VAS-score of over 50% within 15 minutes. |
Secundaire uitkomstmaat is percentage succesvol behandelde clusterhoofdpijn aanvallen, gedefinieerd als een daling in de VAS-score van > 50% binnen 15 minuten. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
15 minutes after start of oxygen treatment |
15 minuten na start van zuurstofbehandeling |
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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 | Yes |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Andere zuurstof stroomsnelheid (7 versus 12 L/min) |
Other oxygen flow rate (7 versus 12 L/min) |
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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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Completed treatment of 100 patients |
Voltooide behandeling van 100 patiënten |
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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 | |