Episodic cluster headache
Conditions
Interventions
Trade Name: Depo-Medrol 40 mg/ml, suspensie voor injectie
Product Name: Methylprednisolonacetaat
Pharmaceutical Form: Injection
Pharmaceutical form of t
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients have to be diagnosed with episodic cluster headache according to the international classification of headache disorders – third edition beta, ICHD-3b - Patients have to be aged 18-65 years - Patients need to be newly diagnosed and treatment naïve, or already diagnosed and currently free from prophylactic treatment - Patients need to have a mean of more than 1 attack per day in the 3 days preceding inclusion. - Patients should be in their cluster period for shorter than 4 weeks before inclusion. 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 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - A contraindication for treatment with steroids or verapamil - The use of anticoagulants or known bleeding disorder. - Use of any prophylactic medication for cluster headache - Patients with a history of other primary headache who are currently using prophylactic medication for this headache - Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To provide a definitive answer regarding the efficacy of GON-injection as first-line prophylactic therapy in episodic cluster headache, by showing that GON-injection decreases the mean total dose of verapamil needed during the treatment of a cluster episode in episodic cluster headache.;Primary end point(s): The primary endpoint of this study is the decrease in mean total dose of verapamil used per day during the study period ;Timepoint(s) of evaluation of this end point: Twelve weeks; Secondary Objective: To Show that the addition of GON-injection leads to - faster attack-freedom (7 consecutive days without attacks) than the current standard treatment with verapamil only. - less side-effects than the current standard treatment with only verapamil. - a decrease in attack frequency, severity and duration of attacks (and thus a decrease in the use of attack medication) compared to the current standard treatment with only verapamil. To learn how long the beneficial effects of GON-injection will last. To show that GON-injection will lead to higher patient satisfaction scores, compared to the current standard treatment with only verapamil. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: 1. Median number of days to remission (7 consecutive days without attack) 2. Mean number of attacks per day 3. Peak dose verapamil 4. Premature termination of study due to need for prophylactic escape medication Tertiary endpoints 5. The total use of attack medication 6. Mean number, severity (1-10) and duration of attack per day. 7. Percentage of patients that are attack-free at days 7, 14 and 28 8. Occurrence of ‘non-cluster’ headache (number of days and mean intensity per affected day) 9. Adverse events 10. Subjective feeling at days 7, 14 and 28 (visual analogue scale, VAS) 11. Satisfaction score (7 point scale, higher scores are better) 12. Would the patient recommend this treatment to others? 13. What treatment does the patient think he/she received (placebo/GON/uncertain)? 14. What treatment do the investigators think the patient has had? ; Timepoint(s) of evaluation of this end point: Every day in in the complete 12-week study period - 1-6, 8, 9 and 11 At the end of each of the three 4-week timeperiods - 5, 6, 8 Days 7, 14, and 28 - 7, 10 Days 2, 28 and at the end of the 12-week study period - 12, 13 and 14 | — |
Countries
Netherlands
Contacts
Public ContactHoofdpijnonderzoek
Leids Universitair Medisch Centrum
Outcome results
None listed