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Dysport® In Migraine Without Aura Prophylaxis : DIMWAP Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00258609
Recruitment Status : Completed
First Posted : November 24, 2005
Last Update Posted : February 18, 2019
Chiang Mai University
Information provided by:
Rajavithi Hospital

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.

Condition or disease Intervention/treatment Phase
Migraine Without Aura Prophylaxis Drug: Botulinum Toxin type A (Dysport ® ) IM/SC 6-sites pericranial injection Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
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 Start Date : February 2003
Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Migraine

Primary Outcome Measures :
  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 Outcome Measures :
  1. MIDAS score, SF36

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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:

• 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00258609

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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, Thailand, 50200
Department of Medicine, Sappasithiprasong Hospital, Public Health Ministry
Ubonratchatani, Thailand
Sponsors and Collaborators
Rajavithi Hospital
Chiang Mai University
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Principal Investigator: Siwaporn Chankrachang, MD Northern Neurological Center, Faculty of Medicine,Chiang Mai University


Layout table for additonal information Identifier: NCT00258609     History of Changes
Other Study ID Numbers: A-38-52120-007
First Posted: November 24, 2005    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019

Keywords provided by Rajavithi Hospital:
Botulinum toxin type A,
Migraine without aura,
Migraine prophylaxis.

Additional relevant MeSH terms:
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Migraine Disorders
Migraine without Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents