Dysport® In Migraine Without Aura Prophylaxis : DIMWAP Study

This study has been completed.
Sponsor:
Collaborators:
Ipsen
Chiang Mai University
Information provided by:
Rajavithi Hospital
ClinicalTrials.gov Identifier:
NCT00258609
First received: November 23, 2005
Last updated: December 22, 2005
Last verified: December 2005
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by Rajavithi Hospital:

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

Estimated Enrollment: 128
Study Start Date: February 2003
Estimated Study Completion Date: June 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00258609

Locations
Thailand
Division of Neurology, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, Thailand
Division of Neurology, Prasart Neurological Institute, Public Health Ministry.
Bangkok, Thailand
Division of Neurology, Department of Medicine, Bhumipol Hospital.
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
Ipsen
Chiang Mai University
Investigators
Principal Investigator: Siwaporn Chankrachang, MD Northern Neurological Center, Faculty of Medicine,Chiang Mai University
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00258609     History of Changes
Other Study ID Numbers: A-38-52120-007
Study First Received: November 23, 2005
Last Updated: December 22, 2005
Health Authority: Thailand: Faculty of Medicine,Chiang Mai University
Thailand : Research ethic committee, Public Health Ministry of Thailand

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

Additional relevant MeSH terms:
Migraine Disorders
Migraine without Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014