Botulinum toxin type A (BOTOX®) for the prophylactic treatment of chronic daily headache: A randomized, double-blind, placebo-controlled trial

Headache

Volumn 45, Issue 4, 2005, Pages 293-307

  Mathew, Ninan T ^a   Frishberg, Benjamin M ^b   Gawel, Marek ^c   Dimitrova, Rozalina ^d   Gibson, John ^d   Turkel, Catherine ^d  

^a Houston Headache Clinic   (United States)

^b Neurology Center   (United States)

^c SUNNYBROOK RESEARCH INSTITUTE   (Canada)

^d ALLERGAN INC   (United States)

Author keywords

Botulinum toxin type A; Chronic daily headache; Double blind; Migraine headache; Placebo controlled; Prophylaxis

Indexed keywords

BOTULINUM TOXIN A; PLACEBO;

ADULT; AGED; ARTICLE; BLEEDING; CHRONIC DAILY HEADACHE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DYSPHAGIA; FACE PAIN; FEMALE; HEADACHE; HUMAN; HYPERESTHESIA; INJECTION PAIN; INJECTION SITE REACTION; MAJOR CLINICAL STUDY; MALE; MUSCLE HYPERTONIA; MUSCLE WEAKNESS; NECK PAIN; PHARYNGITIS; PRIORITY JOURNAL; PROPHYLAXIS; PTOSIS; RANDOMIZED CONTROLLED TRIAL; SCREENING TEST; SHOULDER PAIN; SKIN MANIFESTATION; TREATMENT OUTCOME; VISUAL DISORDER;

ADOLESCENT; ADULT; AGED; BOTULINUM TOXIN TYPE A; DOUBLE-BLIND METHOD; FEMALE; HEADACHE DISORDERS; HUMANS; MALE; MIDDLE AGED; NEUROMUSCULAR AGENTS; SINGLE-BLIND METHOD; TREATMENT OUTCOME;

EID: 17244368592     PISSN: 00178748     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1526-4610.2005.05066.x     Document Type: Article

References (49)

1. Castillo J, Munoz P, Guitera V, Pascual J. Epidemiology of chronic daily headache in the general population. Headache. 1999;39:190-196.
2. Silberstein SD, Lipton RB. Chronic daily headache. Curr Opin Neurol. 2000;13:277-283.
3. Welch KM, Goadsby PJ. Chronic daily headache: nosology and pathophysiology. Curr Opin Neurol. 2002;15:287-295.
4. Wang SJ, Fuh JL, Lu SR, et al. Chronic daily headache in Chinese elderly: prevalence, risk factors, and biannual follow-up. Neurology. 2000;54:314-319.
5. Scher AI, Lipton RB, Stewart W. Risk factors for chronic daily headache. Curr Pain Headache Rep. 2002;6:486-491.
6. Pascual J, Colas R, Castillo J. Epidemiology of chronic daily headache. Curr Pain Headache Rep. 2001;5:529-536.
7. Mathew NT. Chronic refractory headache. Neurology. 1993;43:S26-33.
8. Bigal ME, Sheftell FD, Rapoport AM, Tepper SJ, Lipton RB. Chronic daily headache: identification of factors associated with induction and transformation. Headache. 2002;42:575-581.
9. Newman LC, Lipton RB, Solmon S, et al. Daily headache in a population sample: results from the American Migraine Study. Headache. 1994;34:295.
10. Silberstein SD, Lipton RB, Solomon S, Mathew NT. Classification of daily and near-daily headaches: proposed revisions to the IHS criteria. Headache. 1994;34:1-7.
11. Manzoni GC, Granella F, Sandrini G, Cavallini A, Zanferrari C, Nappi G. Classification of chronic daily headache by International Headache Society criteria: limits and new proposals. Cephalalgia. 1995;15:37-43.
12. Silberstein SD, Lipton RB, Sliwinski M. Classification of daily and near-daily headaches: field trial of revised IHS criteria. Neurology. 1996;47:871-875.
13. Aurora SK. Imaging chronic daily headache. Curr Pain Headache Rep. 2003;7:209-211.
14. Mathew NT, Reuveni U, Perez F. Transformed or evolutive migraine. Headache. 1987;27:102-106.
15. Sandrini G, Manzoni GC, Zanferrari C, Nappi G. An epidemiological approach to the nosography of chronic daily headache. Cephalalgia. 1993;13(suppl 12):72-77.
16. Katsarava Z, Schneeweiss S, Kurth T, et al. Incidence and predictors for chronicity of headache in patients with episodic migraine. Neurology. 2004;62:788-790.
17. Welch KM, Nagesh V, Aurora SK, Gelman N. Periaqueductal gray matter dysfunction in migraine: cause or the burden of illness? Headache. 2001;41:629-637.
18. Kruit MC, van Buchem MA, Hofman PA, et al. Migraine as a risk factor for subclinical brain lesions. JAMA. 2004;291:427-434.
19. Limmroth V, Katsarava Z, Fritsche G, Przywara S, Diener HC. Features of medication overuse headache following overuse of different acute headache drugs. Neurology. 2002;59:1011-1014.
20. Silberstein SD, Winner PK, Chmiel JJ. Migraine preventive medication reduces resource utilization. Headache. 2003;43:171-178.
21. Silvestrini M, Bartolini M, Coccia M, Baruffaldi R, Taffi R, Provinciali L. Topiramate in the treatment of chronic migraine. Cephalalgia. 2003;23:820-824.
22. Spira PJ, Beran RG. Gabapentin in the prophylaxis of chronic daily headache: a randomized, placebo-controlled study. Neurology. 2003;61:1753-1759.
23. rd, Cantrell DT, Winner P, White JR. Chronic daily headache prophylaxis with tizanidine: a double-blind, placebo-controlled, multicenter outcome study. Headache. 2002;42:470-482.
24. Silberstein SD, Goadsby PJ. Migraine: preventive treatment. Cephalalgia. 2002;22:491-512.
25. Redillas C, Solomon S. Prophylactic pharmacological treatment of chronic daily headache. Headache. 2000;40:83-102.
26. Silberstein SD, Neto W, Schmitt J, Jacobs D. Topiramate in migraine prevention: results of a large controlled trial. Arch Neurol. 2004;61:490-495.
27. Brandes JL, Saper JR, Diamond M, et al. Topiramate for migraine prevention: a randomized controlled trial. JAMA. 2004;291:965-973.
28. Dolly O. Synaptic transmission: inhibition of neurotransmitter release by botulinum toxins. Headache. 2003;43(suppl 1):S16-S24.
29. Aoki KR. Evidence for antinociceptive activity of botulinum toxin type a in pain management. Headache. 2003;43(suppl 1):9-15.
30. Cui M, Khanijou S, Rubino J, Aoki KR. Subcutaneous administration of botulinum toxin A reduces formalin-induced pain. Pain. 2004;107:125-133.
31. Durham PL, Cady R, Cady R. Regulation of calcitonin gene-related peptide secretion from trigeminal nerve cells by botulinum toxin type A: implications for migraine therapy. Headache. 2004;44:35-42; discussion 42-43.
32. Barrientos N, Chana P. Botulinum toxin type A in prophylactic treatment of migraine headaches: a preliminary study. J Headache Pain. 2003;4:146-151.
33. Blumenfeld A. Botulinum toxin type a as an effective prophylactic treatment in primary headache disorders. Headache. 2003;43:853-860.
34. Silberstein S, Mathew N, Saper J, Jenkins S, Group FtBMCR. Botulinum toxin type A as a migraine preventive treatment. Headache. 2000;40:445-450.
35. Troost BT. Botulinum toxin type A (BOTOX®) in the treatment of migraine and other headaches. Expert Rev Neurotherapeutics. 2004;41:27-31.
36. Headache Classification Committee of the International Headache Society. Classification and diagnostic criteria for headache disorders, cranial neuralgias and facial pain. Cephalalgia. 1988;8(suppl 7):1-96.
37. Blumenfeld AM, Binder W, Silberstein SD, Blitzer A. Procedures for administering botulinum toxin type A for migraine and tension-type headache Headache. 2003;43:884-891.
38. Stewart WF, Lipton RB, Celentano DD, Reed ML. Prevalence of migraine headache in the United States. Relation to age, income, race, and other sociodemographic factors. JAMA. 1992;267:64-69.
39. Seigel S. Non-parametric statistics for the behavioral sciences. Vol. 96. New York: McGraw-Hill Book Company; 1956:116-127.
40. Headache Classification Subcommittee of the International Headache Society. The international classification of headache disorders. Cephalalgia. 2004;24:1-160.
41. Note for guidance on clinical investigation of medicinal products for the treatment of migraine: European Agency for the Evaluation of Medicinal Products, 2003.
42. TOPAMAX® [package insert]. Raritan, NJ: Ortho-McNeil Pharmaceutical, Inc.; 2004.
43. DEPAKOTE® [package insert]. Abbott Park, IL: Abbott Laboratories, Inc.; 2003.
44. Mathew NT, Saper JR, Silberstein SD, et al. Migraine prophylaxis with divalproex. Arch Neurol. 1995;52:281-286.
45. Couch JR Jr. Placebo effect and clinical trials in migraine therapy. Neuroepidemiology. 1987;6:178-185.
46. Dodick D, Mauskop A, Elkind A, et al. Botulinum toxin type A for the prophylaxis of chronic daily headache: subgroup analysis of patients not receiving other prophylactic medications (a randomized double-blind, placebo-controlled study). Headache. 2005;45:315-324.
47. Naumann M. Safety of botulinum toxin type A: a systematic review and meta-analysis. Curr Med Res Opin. 2004;20:981-990.
48. Brashear A, Gordon MF, Elovic E, et al. Intramuscular injection of botulinum toxin for the treatment of wrist and finger spasticity after a stroke. N Engl J Med. 2004;20:981-990.
49. BOTOX® [package insert]. Irvine, CA: Allergan, Inc.; 2002.