CClinicalTrials.gg
Sign In
CompletedNCT00258609Updated Feb 18, 2019

Dysport® In Migraine Without Aura Prophylaxis : DIMWAP Study

A Phase 3 interventional study of Botulinum Toxin type A (Dysport ® ) IM/SC 6-sites pericranial injection in Migraine Without Aura Prophylaxis, sponsored by Rajavithi Hospital. Completed at 6 sites in Thailand. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-02-18.

Sponsored by Rajavithi Hospital · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to determine whether 120 Unit, and 240 unit of botulinum toxin A are effective in the treatment of migraine without aura prophylaxis.

Read the detailed description

This is a 12-week, prospective double-blinded, randomized, multicenter study of placebo, 120 Unit, and 240 unit of botulinum toxin A ( Dysport ® ) injection for patient with a diagnosis of Migraine without aura according to International Headache Society criteria. It is designed to evaluate the efficacy, safety, tolerability and optimum dose of Botulinum toxin type A (Dysport ®)injection for migraine without aura prophylaxis.

02

Conditions studied

  • Migraine Without Aura Prophylaxis

Keywords

  • Botulinum toxin type A,
  • Dysport®,Dysport
  • Migraine without aura,
  • Migraine prophylaxis.
03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 128 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Rajavithi Hospital is the lead sponsor of 46 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • The patient must give written (personally signed and dated) informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed part of the normal medical care of the patient.• Able to give written inform consent and have a copied one.• Male or female patient age 18 - 65.• Patients are fulfil the International Headache Society diagnostic criteria for migraine• Patients experience an average of 2 to 8 migraine attacks per month over the 3 months and if they recorded 2 to 8 migraine attacks during the screening period. • Patients with prophylactic treatment for migraine have been unchanged for 3 months. • Able to continuation anti - migraine drugs.• Female patient in good general health who is potentially fertile and sexually active must be instructed by the investigator to avoid pregnancy during the study by condom or other contraceptive measure and has negative urine pregnancy test. (if possible at each visit a control of the urine pregnancy test will be performed).• Patients have to judge reliable for medication compliance and recording the effects of medication, as well as clearly motivated to obtain benefit from treatment. • The normal physical and neurological examinations during the whole study period. • Normal result for haematology test • Liver transaminase inferior than 2 upper normal values of the laboratory.

Exclusion criteria

Exclusion Criteria:

  • Patients are fulfil the international Headache Society criteria diagnostic for pure migraine with aura.• The patient is pregnant or lactating.• The patient is a female at risk of pregnancy during the study, not taking adequate precautions against pregnancy.• The patient has a known hypersensitivity to any of the test materials or related compounds.• The patient is unable or unwilling to comply fully with the protocol.• The patient has received any unlicensed drug within the previous 6 months.• Treatment with investigational drug (s) within 6 months before the screening visit.• The patient has previously entered this study.• Patient with past history of predominant tension type headache, botulism, other neuromuscular disorder (e.g. myasthenia gravis, Lambert - Elton Syndrome)• Patient with significant medical / neurological / psychiatric disorders such as blood dyscrasia,thrombocytopenia, rheumatoid arthritis, congestive heart failure, coronary artery heart diseases, dementia, psychosis, major depression or other conditions which could influence the clinical trial. • History of drugs abuse (narcotic (s), cafergot, or others) or drug (botulinum toxin type A) allergy.• Treatment with BTX A within 6 month Treatment or any medical condition that may have put the participant at risk with exposure to BTX-A (neuromuscular disorders, aminoglycoside antibiotics, curare-like agents).• History of migrainous infarction, hemiplegic migraine.• Unable to fill patient diary at home during migraine attack.• Patient who plan to schedule elective surgery during the study.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
128 participants

Interventions

  • DrugBotulinum Toxin type A (Dysport ® ) IM/SC 6-sites pericranial injection
06

What researchers measure

Primary outcomes

  1. Mean change from baseline of Area undercurve of headache diary ( total headache score).

  2. Mean change from baseline of total duration of migraine attack( hours) in 4 weeks.

  3. Mean change from baseline of migraine frequency

Secondary outcomes

  1. MIDAS score, SF36

07

Study locations

6 sites
  • Division of Neurology, Department of Medicine, Bhumipol Hospital.
    Bangkok,, Thailand
  • Division of Neurology, Prasart Neurological Institute, Public Health Ministry.
    Bangkok,, Thailand
  • Division of Neurology, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University
    Bangkok, Thailand
  • Division of Neurology, Department of Medicine, Pramongkutklao Hospital
    Bangkok, Thailand
  • Northern Neurological Center, Faculty of Medicine, Chiang Mai University
    Chiang Mai, 50200, Thailand
  • Department of Medicine, Sappasithiprasong Hospital, Public Health Ministry
    Ubonratchatani, Thailand
08

References and documents

Publications

  • Silberstein S, Mathew N, Saper J, Jenkins S. Botulinum toxin type A as a migraine preventive treatment. For the BOTOX Migraine Clinical Research Group. Headache. 2000 Jun;40(6):445-50. doi: 10.1046/j.1526-4610.2000.00066.x. PubMed 10849039 ↗
  • Evers S, Vollmer-Haase J, Schwaag S, Rahmann A, Husstedt IW, Frese A. Botulinum toxin A in the prophylactic treatment of migraine--a randomized, double-blind, placebo-controlled study. Cephalalgia. 2004 Oct;24(10):838-43. doi: 10.1111/j.1468-2982.2004.00754.x. PubMed 15377314 ↗
  • Tepper SJ, Bigal ME, Sheftell FD, Rapoport AM. Botulinum neurotoxin type A in the preventive treatment of refractory headache: a review of 100 consecutive cases. Headache. 2004 Sep;44(8):794-800. doi: 10.1111/j.1526-4610.2004.04147.x. PubMed 15330826 ↗
  • Turton K, Chaddock JA, Acharya KR. Botulinum and tetanus neurotoxins: structure, function and therapeutic utility. Trends Biochem Sci. 2002 Nov;27(11):552-8. doi: 10.1016/s0968-0004(02)02177-1. PubMed 12417130 ↗
  • Brin MF. Botulinum toxin: chemistry, pharmacology, toxicity, and immunology. Muscle Nerve Suppl. 1997;6:S146-68. PubMed 9826987 ↗
  • Cui M, Khanijou S, Rubino J, Aoki KR. Subcutaneous administration of botulinum toxin A reduces formalin-induced pain. Pain. 2004 Jan;107(1-2):125-33. doi: 10.1016/j.pain.2003.10.008. PubMed 14715398 ↗
  • Borodic GE, Acquadro M, Johnson EA. Botulinum toxin therapy for pain and inflammatory disorders: mechanisms and therapeutic effects. Expert Opin Investig Drugs. 2001 Aug;10(8):1531-44. doi: 10.1517/13543784.10.8.1531. PubMed 11772268 ↗
  • Arezzo JC. Possible mechanisms for the effects of botulinum toxin on pain. Clin J Pain. 2002 Nov-Dec;18(6 Suppl):S125-32. doi: 10.1097/00002508-200211001-00003. PubMed 12569959 ↗
  • Kramer HH, Angerer C, Erbguth F, Schmelz M, Birklein F. Botulinum Toxin A reduces neurogenic flare but has almost no effect on pain and hyperalgesia in human skin. J Neurol. 2003 Feb;250(2):188-93. doi: 10.1007/s00415-003-0971-x. PubMed 12574949 ↗
  • Blersch W, Schulte-Mattler WJ, Przywara S, May A, Bigalke H, Wohlfarth K. Botulinum toxin A and the cutaneous nociception in humans: a prospective, double-blind, placebo-controlled, randomized study. J Neurol Sci. 2002 Dec 15;205(1):59-63. doi: 10.1016/s0022-510x(02)00313-1. PubMed 12409185 ↗
  • Caputi CA. Effectiveness of BoNT-A in the treatment of migraine and its ability to repress CGRP release. Headache. 2004 Sep;44(8):837-8. doi: 10.1111/j.1526-4610.2004.04158_1.x. No abstract available. PubMed 15330838 ↗
  • Smuts JA, Schultz D, Barnard A. Mechanism of action of botulinum toxin type A in migraine prevention: a pilot study. Headache. 2004 Sep;44(8):801-5. doi: 10.1111/j.1526-4610.2004.04148.x. PubMed 15330827 ↗
  • 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 Jan;44(1):35-42; discussion 42-3. doi: 10.1111/j.1526-4610.2004.04007.x. PubMed 14979881 ↗
  • Silberstein SD. Review of botulinum toxin type A and its clinical applications in migraine headache. Expert Opin Pharmacother. 2001 Oct;2(10):1649-54. doi: 10.1517/14656566.2.10.1649. PubMed 11825307 ↗
  • Aoki KR. Evidence for antinociceptive activity of botulinum toxin type A in pain management. Headache. 2003 Jul-Aug;43 Suppl 1:S9-15. doi: 10.1046/j.1526-4610.43.7s.3.x. PubMed 12887389 ↗
  • Blumenfeld AM, Dodick DW, Silberstein SD. Botulinum neurotoxin for the treatment of migraine and other primary headache disorders. Dermatol Clin. 2004 Apr;22(2):167-75. doi: 10.1016/s0733-8635(03)00105-0. PubMed 15222577 ↗
  • Gobel H. Botulinum toxin in migraine prophylaxis. J Neurol. 2004 Feb;251 Suppl 1:I8-11. doi: 10.1007/s00415-004-1103-y. PubMed 14991336 ↗
  • Evers S, Rahmann A, Vollmer-Haase J, Husstedt IW. Treatment of headache with botulinum toxin A--a review according to evidence-based medicine criteria. Cephalalgia. 2002 Nov;22(9):699-710. doi: 10.1046/j.1468-2982.2002.00390.x. PubMed 12421155 ↗
  • Chankrachang S, Arayawichanont A, Poungvarin N, Nidhinandana S, Boonkongchuen P, Towanabut S, Sithinamsuwan P, Kongsaengdao S. Prophylactic botulinum type A toxin complex (Dysport(R)) for migraine without aura. Headache. 2011 Jan;51(1):52-63. doi: 10.1111/j.1526-4610.2010.01807.x. Epub 2010 Nov 16. PubMed 21083558 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00258609
Lead sponsor
Rajavithi Hospital
Collaborators
Ipsen, Chiang Mai University
First posted
Nov 24, 2005
Start date
Feb 2003
Completion
Jun 2004
Last update
Feb 18, 2019

Study contacts

Siwaporn Chankrachang, MD
principal investigator · Northern Neurological Center, Faculty of Medicine,Chiang Mai University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Migraine Disorders→

Other studies from this sponsor

Rajavithi Hospital

Start the discussion