Migraine Without Aura ProphylaxisPhase 3NCT00258609
Dysport® In Migraine Without Aura Prophylaxis : DIMWAP Study
A Phase 3 study testing Botulinum Toxin type A (Dysport ® ) IM/SC 6-sites pericranial injection in people with Migraine Without Aura Prophylaxis, run by Department of Medical Services Ministry of Public Health of Thailand at 6 sites in Thailand.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Without Aura Prophylaxis
- What is being tested?
- Botulinum Toxin type A (Dysport ® ) IM/SC 6-sites pericranial injection
- Type of treatment
- Injection or infusion
- How many people
- 128 participants
- Where
- 6 sitesThailand
- Study dates
- Feb 2003to Jun 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Thailand6 sites
Division of Neurology, Department of Medicine, Bhumipol Hospital.
Bangkok
Division of Neurology, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok
Division of Neurology, Department of Medicine, Pramongkutklao Hospital
Bangkok
Division of Neurology, Prasart Neurological Institute, Public Health Ministry.
Bangkok
Northern Neurological Center, Faculty of Medicine, Chiang Mai University
Chiang Mai, 50200
Department of Medicine, Sappasithiprasong Hospital, Public Health Ministry
Ubonratchatani
About this 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.
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.
- Conditions
- Migraine Without Aura Prophylaxis
- Being tested
- Botulinum Toxin type A (Dysport ® ) IM/SC 6-sites pericranial injection
- Keywords
- Botulinum toxin type A,, Dysport®,Dysport, Migraine without aura,, Migraine prophylaxis.
- Medical subject headings
- Migraine without Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin type A (Dysport ® ) IM/SC 6-sites pericranial injectionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
MIDAS score, SF36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2005 (estimated)
- Study startFeb 2003
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Migraine Without Aura ProphylaxisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 128 participants
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Collaborators
- Ipsen, Chiang Mai University
- Investigators
- Siwaporn Chankrachang, MD, Principal investigator, Northern Neurological Center, Faculty of Medicine,Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00258609
- Sponsor's protocol ID
- A-38-52120-007
- Status last verified
- Feb 2019
- First submitted
- 23 Nov 2005
- Last updated
- 18 Feb 2019
- Results posted
- No
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 10849039Evers 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 15377314Tepper 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 15330826Turton 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 12417130Brin MF. Botulinum toxin: chemistry, pharmacology, toxicity, and immunology. Muscle Nerve Suppl. 1997;6:S146-68.
PubMed 9826987Cui 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 14715398Borodic 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 11772268Arezzo 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 12569959Kramer 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 12574949Blersch 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 12409185Caputi 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 15330838Smuts 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 15330827Durham 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 14979881Silberstein 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 11825307Aoki 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00258609
- Acronym / sponsor ID
- A-38-52120-007
- Conditions
- Migraine Without Aura Prophylaxis
- Keywords
- Botulinum toxin type A,, Dysport®,Dysport, Migraine without aura,, Migraine prophylaxis.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Collaborators
- Ipsen, Chiang Mai University
- Study start
- Feb 2003
- Study completion
- Jun 2004
- First posted
- 24 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin type A (Dysport ® ) IM/SC 6-sites pericranial injection | Drug | – |
Primary outcome
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
1 secondary outcome
MIDAS score, SF36
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Background: PubMed 10849039Silberstein 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.
- Background: PubMed 15377314Evers 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.
- Background: PubMed 15330826Tepper 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.
- Background: PubMed 12417130Turton 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.
- Background: PubMed 9826987Brin MF. Botulinum toxin: chemistry, pharmacology, toxicity, and immunology. Muscle Nerve Suppl. 1997;6:S146-68.
- Background: PubMed 14715398Cui 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.
- Background: PubMed 11772268Borodic 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.
- Background: PubMed 12569959Arezzo 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.
- Background: PubMed 12574949Kramer 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.
- Background: PubMed 12409185Blersch 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.
- Background: PubMed 15330838Caputi 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.
- Background: PubMed 15330827Smuts 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siwaporn Chankrachang, MD principal investigator
Northern Neurological Center, Faculty of Medicine,Chiang Mai University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum Toxin type A (Dysport ® ) IM/SC 6-sites pericranial injection in people with Migraine Without Aura Prophylaxis, run by Department of Medical Services Ministry of Public Health of Thailand at 6 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline of Area undercurve of headache diary ( total headache score).. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00258609, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2019.