search
Back to results

Dysport® In Migraine Without Aura Prophylaxis : DIMWAP Study

Primary Purpose

Migraine Without Aura Prophylaxis

Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Botulinum Toxin type A (Dysport ® ) IM/SC 6-sites pericranial injection
Sponsored by
Rajavithi Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Migraine Without Aura Prophylaxis focused on measuring Botulinum toxin type A,, Dysport®,Dysport, Migraine without aura,, Migraine prophylaxis.

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: • 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.

Sites / Locations

  • Division of Neurology, Department of Medicine, Bhumipol Hospital.
  • Division of Neurology, Prasart Neurological Institute, Public Health Ministry.
  • Division of Neurology, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University
  • Division of Neurology, Department of Medicine, Pramongkutklao Hospital
  • Northern Neurological Center, Faculty of Medicine, Chiang Mai University
  • Department of Medicine, Sappasithiprasong Hospital, Public Health Ministry

Outcomes

Primary Outcome Measures

Mean change from baseline of Area undercurve of headache diary ( total headache score).
Mean change from baseline of total duration of migraine attack( hours) in 4 weeks.
Mean change from baseline of migraine frequency

Secondary Outcome Measures

MIDAS score, SF36

Full Information

First Posted
November 23, 2005
Last Updated
February 15, 2019
Sponsor
Rajavithi Hospital
Collaborators
Ipsen, Chiang Mai University
search

1. Study Identification

Unique Protocol Identification Number
NCT00258609
Brief Title
Dysport® In Migraine Without Aura Prophylaxis : DIMWAP Study
Official Title
A 12-week Prospective, Double-blinded, Randomized, Multicenter Study of Low Dose and Medium Dose Botulinum Toxin Type A (Dysport® ) Injection for Migraine Prophylaxis.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Rajavithi Hospital
Collaborators
Ipsen, Chiang Mai University

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Without Aura Prophylaxis
Keywords
Botulinum toxin type A,, Dysport®,Dysport, Migraine without aura,, Migraine prophylaxis.

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
128 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin type A (Dysport ® ) IM/SC 6-sites pericranial injection
Primary Outcome Measure Information:
Title
Mean change from baseline of Area undercurve of headache diary ( total headache score).
Title
Mean change from baseline of total duration of migraine attack( hours) in 4 weeks.
Title
Mean change from baseline of migraine frequency
Secondary Outcome Measure Information:
Title
MIDAS score, SF36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: • 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siwaporn Chankrachang, MD
Organizational Affiliation
Northern Neurological Center, Faculty of Medicine,Chiang Mai University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Neurology, Department of Medicine, Bhumipol Hospital.
City
Bangkok,
Country
Thailand
Facility Name
Division of Neurology, Prasart Neurological Institute, Public Health Ministry.
City
Bangkok,
Country
Thailand
Facility Name
Division of Neurology, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University
City
Bangkok
Country
Thailand
Facility Name
Division of Neurology, Department of Medicine, Pramongkutklao Hospital
City
Bangkok
Country
Thailand
Facility Name
Northern Neurological Center, Faculty of Medicine, Chiang Mai University
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Department of Medicine, Sappasithiprasong Hospital, Public Health Ministry
City
Ubonratchatani
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
10849039
Citation
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.
Results Reference
background
PubMed Identifier
15377314
Citation
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.
Results Reference
background
PubMed Identifier
15330826
Citation
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.
Results Reference
background
PubMed Identifier
12417130
Citation
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.
Results Reference
background
PubMed Identifier
9826987
Citation
Brin MF. Botulinum toxin: chemistry, pharmacology, toxicity, and immunology. Muscle Nerve Suppl. 1997;6:S146-68.
Results Reference
background
PubMed Identifier
14715398
Citation
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.
Results Reference
background
PubMed Identifier
11772268
Citation
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.
Results Reference
background
PubMed Identifier
12569959
Citation
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.
Results Reference
background
PubMed Identifier
12574949
Citation
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.
Results Reference
background
PubMed Identifier
12409185
Citation
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.
Results Reference
background
PubMed Identifier
15330838
Citation
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.
Results Reference
background
PubMed Identifier
15330827
Citation
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.
Results Reference
background
PubMed Identifier
14979881
Citation
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.
Results Reference
background
PubMed Identifier
11825307
Citation
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.
Results Reference
background
PubMed Identifier
12887389
Citation
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.
Results Reference
background
PubMed Identifier
15222577
Citation
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.
Results Reference
background
PubMed Identifier
14991336
Citation
Gobel H. Botulinum toxin in migraine prophylaxis. J Neurol. 2004 Feb;251 Suppl 1:I8-11. doi: 10.1007/s00415-004-1103-y.
Results Reference
background
PubMed Identifier
12421155
Citation
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.
Results Reference
background
PubMed Identifier
21083558
Citation
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.
Results Reference
background

Learn more about this trial

Dysport® In Migraine Without Aura Prophylaxis : DIMWAP Study

We'll reach out to this number within 24 hrs