A Randomized, double blind, placebo-controlled study of MAP0004 in adult patients with migraine

Headache

Volumn 49, Issue 6, 2009, Pages 826-837

  Aurora, Sheena K ^a   Rozen, Todd D ^b   Kori, Shashidhar H ^c   Shrewsbury, Stephen B ^c  

^a Swedish Headache Center   (United States)

^b Michigan Head Pain and Neurological Institute   (United States)

^c MAP Pharmaceuticals Inc   (United States)

Author keywords

Clinical trial; Dihydroergotamine mesylate; Inhalation; Migraine

Indexed keywords

DIHYDROERGOTAMINE MESILATE; MAP 0004; PLACEBO; UNCLASSIFIED DRUG;

ACUTE DISEASE; ADULT; ANALGESIA; ARTICLE; BLOOD EXAMINATION; CHILL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSGEUSIA; ELECTROCARDIOGRAM; ELECTROCARDIOGRAPHY; FEMALE; FLUSHING; HUMAN; HYPESTHESIA; LABORATORY TEST; MAJOR CLINICAL STUDY; MALE; METERED DOSE INHALER; MIGRAINE WITH AURA; MIGRAINE WITHOUT AURA; MULTICENTER STUDY; MUSCLE TIGHTNESS; NAUSEA; PAROSMIA; PLUME; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SMELLING DISORDER; SPIROMETRY; UNITED STATES; UNSPECIFIED SIDE EFFECT; URINALYSIS; VITAL SIGN; VOMITING;

ADMINISTRATION, INHALATION; ADOLESCENT; ADULT; ANALGESICS, NON-NARCOTIC; DIHYDROERGOTAMINE; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; MIGRAINE DISORDERS; PAIN MEASUREMENT; TIME FACTORS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 67650095021     PISSN: 00178748     EISSN: 15264610     Source Type: Journal    
DOI: 10.1111/j.1526-4610.2009.01453.x     Document Type: Article

References (27)

1. Stovner LJ, Hagen K, Jensen R, et al. The global burden of headache: A documentation of headache prevalence and disability worldwide. Cephalalgia. 2007 27 : 193 210.
2. Silberstein S, Loder E, Diamond S, Reed ML, Bigal ME, Lipton RB, on Behalf of the AMPP Advisory Group. Probable migraine in the United States: Results of the American Migraine Prevalence and Prevention (AMPP) Study. Cephalalgia. 2007 27 : 220 229.
3. Lipton RB, Hamelsky SW, Dayno JM. What do patients with migraine want from acute migraine treatment? Headache: The Journal of Head and Face Pain. 2002 42 (Suppl. 1 3 9.
4. Gallagher RM, Kunkel R. Migraine medication attributes important for patient compliance: Concerns about side effects may delay treatment. Headache: The Journal of Head and Face Pain. 2003 43 : 36 43.
5. Ferrari MD, Roon KI, Lipton RB, Goadsby PJ. Oral triptans (serotonin 5-HT(1B/1D) agonists) in acute migraine treatment: A meta-analysis of 53 trials. Lancet. 2001 358 : 1668 1675.
6. Aurora S, Kori S, Barrodale P, Nelsen A, McDonald S. Gastric stasis occurs in spontaneous, visually induced, and interictal migraine. Headache: The Journal of Head and Face Pain. 2007 47 : 1443 1446.
7. Aurora SK, Kori SH, Barrodale P, McDonald SA, Haseley D. Gastric stasis in migraine: More than just a paroxysmal abnormality during a migraine attack. Headache: The Journal of Head and Face Pain. 2006 46 : 57 63.
8. Boyle R, Behan PO, Sutton JA. A correlation between severity of migraine and delayed gastric emptying measured by an epigastric impedance method. Br J Clin Pharmacol. 1990 30 : 405 409.
9. Thomsen LL, Dixon R, Lassen LH, et al. 311C90 (Zolmitriptan), a novel centrally and peripheral acting oral 5-hydroxytryptamine-1D agonist: A comparison of its absorption during a migraine attack and in a migraine-free period. Cephalalgia. 1996 16 : 270 275.
10. Tokola RA, Neuvonen P-TJ. Effect of migraine attacks on paracetamol absorption. Br J Clin Pharmacol. 1984 18 : 867 871.
11. Volans GN. Absorption of effervescent aspirin during migraine. Br Med J. 1974 4 : 265 268.
12. Silberstein SD. Practice parameter: Evidence-based guidelines for migraine headache (an evidence-based review): Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2000 55 : 754 762.
13. Schuurmans A, van Weel C. Pharmacologic treatment of migraine. Comparison of guidelines. Can Fam Physician. 2005 51 : 838 843.
14. Saper JR, Silberstein S, Dodick D, Rapoport A. DHE in the pharmacotherapy of migraine: Potential for a larger role. Headache: The Journal of Head and Face Pain. 2006 46 (Suppl. 4 S212 S220.
15. Silberstein SD, McCrory DC. Ergotamine and dihydroergotamine: History, pharmacology, and efficacy. Headache: The Journal of Head and Face Pain. 2003 43 : 144 166.
16. Goadsby PJ, Lipton RA, Ferrari MD. Migraine - current understanding and treatment. N Engl J Med. 2002 346 : 257 270.
17. Armer TA, Shrewsbury SB, Newman SP, Pitcairn G, Ramadan N. Aerosol delivery of ergotamine tartrate via a breath synchronized plume-control inhaler in humans. Curr Med Res Opin. 2007 23 : 3177 3187.
18. Shrewsbury SB, Cook RO, Taylor G, Edwards C, Ramadan NM. Safety and pharmacokinetics of dihydroergotamine mesylate administered via a novel (Tempo™) inhaler. Headache: The Journal of Head and Face Pain. 2008 48 : 355 367.
19. International Headache Society Clinical Trials Subcommittee. Guidelines for controlled trials of drugs in migraine: Second edition. Cephalalgia. 2000 20 : 765 786.
20. Colman I, Brown MD, Innes GD, Grafstein E, Roberts TE, Rowe BH. Parenteral dihydroergotamine for acute migraine headache: A systematic review of the literature. Ann Emerg Med. 2005 45 : 393 401.
21. Goadsby PJ. Recent advances in the diagnosis and management of migraine. BMJ. 2006 332 : 25 29.
22. Saper JR, Silberstein S. Pharmacology of dihydroergotamine and evidence for efficacy and safety in migraine. Headache: The Journal of Head and Face Pain. 2006 46 : S171 S181.
23. Winner P, Ricalde O, Le Force B, et al. A double-blind study of subcutaneous dihydroergotamine versus subcutaneous sumatriptan in the treatment of acute migraine. Arch Neurol. 1996 53 : 180 184.
24. Wyss PA, Rosenthaler J, Neusch E, Aellig WH. Pharmacokinetic investigation of oral and IV dihydroergotamine in healthy subjects. Eur J Clin Pharmacol. 1991 41 : 597 602.
25. Cook R, Shrewsbury S, Ramadan N. 5-HT, adrenergic, dopaminergic receptor binding: Implications for inhaled dosing with dihydroergotamine mesylate via a novel system (Tempo™ inhaler). Presented at the American Headache Society 49th Annual Headache Symposium, June 2007, Chicago, Illinois.
26. Antonaci F, Chimento P, Diener HC, Sances G, Bono G. Lessons from placebo effects in migraine treatment. J Headache Pain. 2007 8 : 63 66.
27. Diener H-C, Dowson AJ, Ferrari M, Nappi G, Tfelt-Hansen P. Unbalanced randomization influences placebo response: Scientific versus ethical issues around the use of placebo in migraine trials. Cephalalgia. 1999 19 : 699 700.