Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
CNS Drugs
Published in: CNS Drugs 15/2004

01-12-2004 | Original Research Article

The PROMISE Study: PROphylaxis of Migraine with SEglor® (Dihydroergotamine Mesilate) in French Primary Care

Authors: Prof. André Pradalier, Michel Lantéri-Minet, Gilles Géraud, Hervé Attain, Christian Lucas, Antonio Delgado

Published in: CNS Drugs | Issue 15/2004

Login to get access

Abstract

Introduction: Seglor® capsules, a unique modified-release formulation of dihydroergotamine mesilate, have long been in clinical use in France for migraine prophylaxis. The aim of the PROMISE (PROphylaxis of Migraine with SEglor®) study was to establish the efficacy and tolerability of Seglor® in the prevention of migraine in a general practice setting.
Methods: The PROMISE study was a double blind, placebo-controlled, parallel-group study carried out in primary care practice. It included 363 migraine patients treated with Seglor® or placebo for 5 months after a 1-month placebo run-in phase.
Results: Migraine attack frequency (primary efficacy criterion) decreased markedly in the two treatment groups so that the difference in favour of Seglor® did not reach statistical significance. However, most secondary outcome measures (duration of single attack, total duration of attacks over 1 month, consumption of mild opiate analgesics, subjective improvement) improved to a significantly greater degree in patients receiving Seglor® than in those receiving placebo. In the 84.5% of patients who had impaired quality of life at entry, the percentage of reduction in attack frequency and most other efficacy measures showed significant improvement with Seglor®. The safety profile for Seglor® was comparable to that of placebo.
Conclusion: These results support the effectiveness of Seglor® in patients with migraine-related quality-of-life impairment. The findings of the PROMISE study also suggest that patients’ quality of life should be assessed systematically before initiating a preventive treatment for migraine.
Footnotes
1
The use of trade names is for product identification purposes only and does not imply endorsement.
 
Literature
1.
Dahlöf CG, Dimenas E. Migraine patients experience poorer subjective well-being/quality of life even between attacks. Cephalalgia 1995; 15: 31–6PubMedCrossRef
2.
Osterhaus JT, Townsend RJ, Gandek B, et al. Measuring the functional status and well-being of patients with migraine headache. Headache 1994; 34: 337–43PubMedCrossRef
3.
Richard A, Henry P, Chazot G, et al. Quality of life and migraine: validation of the QVM questionnaire in hospital consultation and in general medicine [in French]. Therapie 1993; 48: 89–96PubMed
4.
Terwindt GM, Ferrari MD, Tijhuis M, et al. The impact of migraine on quality of life in the general population: the GEM study. Neurology 2000; 55: 624–9PubMedCrossRef
5.
Mathew NT, Kurman R, Perez F. Drug induced refractory headache: clinical features and management. Headache 1990; 30: 634–8PubMedCrossRef
6.
Rapoport AM. Pharmacological prevention of migraine. Clin Neurosci 1998; 5: 55–9PubMed
7.
Lantéri-Minet M. Analgesic-induced chronic headaches. Pathol Biol 2000; 48: 707–14PubMed
8.
9.
Agence Nationale d’Accréditation et d’Evaluation en Santé (ANAES). Diagnostic and therapeutic management of migrainein adults and children. Clinical and economic aspects: recommendations [online]. Available from URL: http://​www.​anaes.​fr [Accessed 2002 Oct]
10.
Lantéri-Minet M, Alchaar H, Besson G, et al. Prophylaxis for migraine headache: a pharmacoepidemiological study of practices used by primary care physicians and neurologists in France. Rev Neurol (Paris) 2000; 156: 1106–12
11.
Langohr HD, Reinecke M, Gerber WD, et al. Dihydroergotamine and flunarizine in the prevention of migraine: a comparative double-blind study. Fortschr Med 1988; 106: 65–70PubMed
12.
Martucci N, Manna V, Mattesi P, et al. Ergot derivatives in the prophylaxis of migraine: a multicentric study with a timed-release dihydroergotamine formulation. Cephalalgia 1983; 3Suppl. 1: 151–5PubMed
13.
Neuman M, Demarez JP, Harmey JL, et al. Prevention of migraine attacks through the use of dihydroergotamine. Int J Clin Pharmacol Res 1986; 6: 11–3PubMed
14.
Pradalier A, Dry J, Loisy B, et al. Comparative study of indoramin versus dihydroergotamine in the preventive treatment of migraine. Therapie 1988; 43: 293–7PubMed
15.
Aylward M, Davies DE, Maddock J, et al. On the treatment of migraine: pharmacokinetic-pharmacodynamic relationships for a programmed release formulation of dihydroergotamine administered orally in the human. Cephalalgia 1983; 3Suppl. 1: 146–50PubMed
16.
International Headache Society Clinical Trials Subcommittee. Guidelines for controlled trials of drugs in migraine: second edition. Cephalalgia 2000; 20: 765–86CrossRef
17.
Headache Classification Committee of the International Headache Society. Classification and diagnostic criteria for headache disorders, cranial neuralgia, and facial pain. Cephalalgia 1988; 8Suppl. 7: 1–96
18.
Ventafridda V, Saita L, Ripamonti C, et al. WHO guidelines for the use of analgesics in cancer pain. Int J Tissue React 1985; 7: 93–6PubMed
19.
Jhingran P, Osterhaus JT, Miller DW, et al. Development and validation of the Migraine-Specific Quality of Life questionnaire. Headache 1998; 38: 295–302PubMedCrossRef
20.
Steiner TJ, Ahmed F, Findley LJ, et al. S-fluoxetine in the prophylaxis of migraine: a phase II double-blind randomized placebo-controlled study. Cephalalgia 1998; 18: 283–6PubMedCrossRef
21.
Silberstein SD. The pharmacology of ergotamine and dihydroergotamine. Headache 1997; 37Suppl. 1: 15–25PubMed
22.
Lance JW. Current concepts of migraine pathogenesis. Neurology 1993; 43Suppl. 3: 11–5
23.
Newman-Tancredi A, Conte C, Chaput C, et al. Agonist activity of antimigraine drugs at recombinant human 5-HT1a receptors: potential implications for prophylactic and acute therapy. Naunyn Schmiedebergs Arch Pharmacol 1997; 355: 682–8PubMedCrossRef
24.
Hanoun N, Saurini F, Lanfumey L, et al. Dihydroergotamine and its metabolite, 8′-hydroxy-dihydroergotamine, as 5-HT1a receptor agonists in the rat brain. Br J Pharmacol 2003; 139: 424–34PubMedCrossRef
25.
Hamon M, Maroteaux L, Lanfumey L, et al. 5-HT1a and 5-HT2B/2C serotonin receptors: potential targets for the preventive treatment of migraine. Rev Neurol (Paris) 2002; 158Suppl. 2: 190
26.
Schaerlinger B, Hickel P, Etienne N, et al. Agonist actions of dihydroergotamine at 5-HT2B and 5-HT2C receptors and their possible relevance to antimigraine efficacy. Br J Pharmacol 2003; 140: 277–84PubMedCrossRef
27.
Merikangas KR. Association between psychopathology and headache syndromes. Curr Opin Neurol 1995; 8: 248–51PubMedCrossRef
28.
Radat F. Psychopathology and headache. Rev Neurol (Paris) 2000; 156Suppl. 4: 62–7
29.
Stewart W, Breslau N, Keck PE. Comorbidity of migraine and panic disorder. Neurology 1994; 44Suppl. 7: 23–7
30.
Diener HC, Föh M, Iaccarino C, et al. Cyclandelate in the prophylaxis of migraine: a randomized, parallel, double-blind study in comparison with placebo and propranolol. Cephalalgia 1996; 16: 441–7PubMedCrossRef
31.
Kaniecki RG. A comparison of divalproex with propranolol and placebo for the prophylaxis of migraine without aura. Arch Neurol 1997; 54: 1141–5PubMedCrossRef
32.
Klapper J. Divalproex sodium in migraine prophylaxis: a dose-controlled study. Cephalalgia 1997; 17: 103–8PubMedCrossRef
33.
van de Ven LLM, Franke CL, Koehler PJ. Prophylactic treatment of migraine with bisoprolol: a placebo-controlled study. Cephalalgia 1997; 17: 596–9PubMedCrossRef
34.
Schoenen J, Jacquy J, Lenaerts M. Effectiveness of high-dose riboflavin in migraine prophylaxis: a randomized controlled trial. Neurology 1998; 50: 466–70PubMedCrossRef
35.
Pfaffenrath V, Diener HC, Fischer M, et al. The efficacy and safety of Tanacetum parthenium (feverfew) in migraine prophylaxis: a double-blind, multicentre, randomized placebo-controlled dose-response study. Cephalalgia 2002; 22: 523–32PubMedCrossRef
36.
Migraine-Nimodipine European Study Group (MINES). European multicenter trial of nimodipine in the prophylaxis of common migraine (migraine without aura). Headache 1989; 29: 633–8CrossRef
37.
Migraine-Nimodipine European Study Group (MINES). European multicenter trial of nimodipine in the prophylaxis of classic migraine (migraine with aura). Headache 1989; 29: 639–42CrossRef
Metadata
Title
The PROMISE Study: PROphylaxis of Migraine with SEglor® (Dihydroergotamine Mesilate) in French Primary Care
Authors
Prof. André Pradalier
Michel Lantéri-Minet
Gilles Géraud
Hervé Attain
Christian Lucas
Antonio Delgado
Publication date
01-12-2004
Publisher
Springer International Publishing
Published in
CNS Drugs / Issue 15/2004
Print ISSN: 1172-7047
Electronic ISSN: 1179-1934
DOI
https://doi.org/10.2165/00023210-200418150-00009

Other articles of this Issue 15/2004

CNS Drugs 15/2004 Go to the issue

Original Research Article

Acute Treatment of Migraine with Zolmitriptan 5mg Orally Disintegrating Tablet

Correspondence

Zotepine for Behavioural and Psychological Symptoms in Dementia: An Open-Label Study

Original Research Article

Impact of Rivastigmine Use on the Risk of Nursing Home Placement in a US Sample

Review Article

Role of the Serotonergic System in the Neurobiology of Alcoholism

Current Opinion

Interferons in Relapsing-Remitting Multiple Sclerosis

Acknowledgments

Acknowledgement