Episodic cluster headache MedDRA version: 8.0 Level: LLT Classification code 10009698
Conditions
Interventions
Trade Name: Allegro 2.5 mg Filmtabletten
Product Name: Frovatriptan
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Frovatriptan
CAS Number: 158747-02-5
Concentration unit: mg milligram(s
Sponsors
Berlin-Chemie AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria that are to be determined at visit 1, day –7 (Run-in), to be considered eligible for study entry: 1. Written informed consent 2. Age between 18 and 65 years 3. Known episodic cluster headache, diagnosed according to the criteria of the International Headache Society (IHS)11; duration of an individual attack lasting between 15 minutes and 180 minutes, localisation strictly unilateral, cluster headache intensity at least moderate 4. At least second episode of cluster headache 5. Duration since onset of first attack of the current episode at least one week 6. Expected duration of cluster episode at least 6 weeks after start of screening 7. Response to oxygen inhalation (relevant change in headache severity) Additionally, the patient has to meet the following inclusion criterion that is to be determined at visit 2, day 0 (baseline, randomisation): Attack frequency between one attack every two days and eight attacks per day 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients must not meet any of the following exclusion criteria to be considered eligible for study entry: 1. Any form of cluster headache other than episodic cluster headache 2. History of alcohol and/or drug and/or substance abuse 3. Progressive neurologic disease, i.e. cerebral tumours or structural brain damage caused by a birth defect, trauma, or infection 4. History of myocardial infarction, coronary vasospasm (e.g., Prinzmetal’s angina) 5. History or signs or symptoms of ischaemic heart disease 6. Stage II hypertension (SBP ³ 160 mmHg or DBP ³ 100 mmHg) or uncontrolled stage I hypertension (according to JNC) 7. History of peripheral vascular disease 8. Condition following apoplexy or history of transient ischaemic attack 9. Severe hepatic insufficiency (Child-Pugh C) 10. Severe renal insufficiency 11. Congenital disorders like Galactosaemia, Lactase deficiency or Glucose-Galactose malabsorption 12. Clinically significant psychiatric diseases 13. Known hypersensitivity to triptans or any of the ingredients of the study medication 14. Previous prophylactic treatment of cluster headache with frovatriptan within the last 30 days 15. Previous treatment within 6 months prior to the beginning of the study or concomitant treatment with substances which may decrease the efficacy of the test substance(s) or may lead to drug interactions, for example a) antipsychotic drugs b) antidepressant drugs 16. Prophylactic and concomitant treatment of cluster headache e.g., verapamil, lithium, valproic acid (divalproex sodium), topiramate, gabapentin, lamotrigine, melatonin changed within one month prior to Visit 1 or changed during the study 17. Prophylactic and concomitant treatment with corticosteroids, civamide or botulinum toxin A 18. Previous treatment within 24 hours prior to the beginning of the study or concomitant treatment with other triptans (including treatment of acute attacks with subcutaneous sumatriptan) 19. Previous treatment within 24 hours prior to the beginning of the study or concomitant treatment with ergotamine, ergotamine derivatives (including methysergide) or other 5-hydroxytryptamine(5-HT1)-receptor agonists 20. Concomitant anaesthesia of the greater optical nerve 21. Concomitant treatment with herbal remedies containing St. John’s Wort 22. Women of childbearing potential without adequate contraception; Medically acceptable methods are those with a failure rate less than 1% per year, such as contraceptive implant, contraceptive injection, some intrauterine devices (IUD), or combined oral contraceptives taken for at least 3 months, which the patient agrees to continue using during the study 23. Current participation in another clinical study or patients who have received an investigational drug within 30 days prior to entering the study 24. Patients who are unwilling or unable to provide informed consent or to participate satisfactorily for the entire trial 25. Known HIV, HBV or HCV infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of 5 mg frovatriptan given once daily on the frequency of cluster headache attacks as compared to placebo. ;Secondary Objective: Secondary objective(s): To assess the effect of frovatriptan as compared to placebo on: (1) the frequency of cluster headache attacks during the follow-up period; (2) the pain intensity of the cluster headache attacks; (3) the duration of the cluster headache attacks; (4) the associated autonomic symptoms of the cluster headache attacks; (5) the frequency of used oxygen for symptomatic treatment of the cluster headache attacks; (6) the use of additional drug treatment of the cluster headache attacks; (7) the quality of life as documented in the SF-36 questionnaire; (8) the global evaluation of therapy; (9) the therapy satisfaction;Primary end point(s): Mean cluster headache attack frequency per week during the two weeks treatment period. | — |
Countries
Germany
Outcome results
None listed