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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01389193
Registration number
NCT01389193
Ethics application status
Date submitted
29/06/2011
Date registered
8/07/2011
Date last updated
29/12/2015
Titles & IDs
Public title
Ibudilast in the Treatment of Patients With Chronic Migraine.
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Scientific title
Targeting Glial Inhibition to Attenuate Chronic Migraine: AN INTERNATIONAL DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED TRIAL OF IBUDILAST
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Secondary ID [1]
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MRF and DRC
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Secondary ID [2]
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IBU-003
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Universal Trial Number (UTN)
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Trial acronym
IBU-003
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Migraine Headache
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Condition category
Condition code
Neurological
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Other neurological disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ibudilast
Treatment: Drugs - Placebo
Experimental: Ibudilast -
Placebo comparator: Placebo -
Treatment: Drugs: Ibudilast
Ibudilast 40 mg twice daily oral capsules for a duration of 8 weeks
Treatment: Drugs: Placebo
Placebo 40 mg twice daily oral capsules for a duration of 8 weeks
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Primary efficacy end point
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Assessment method [1]
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As suggested by the IHS guidelines for clinical trials in chronic migraine, the primary efficacy endpoint will be number of headache days per month with moderate or severe intensity. Study outcomes will be assessed at baseline and at weeks 2, 4 and 8 of each treatment period.
To monitor treatment with ibudilast, blood biochemistry (including assessment of renal and hepatic including GGT function) and haematology will be assessed at baseline, and at weeks 2, 4 and 8 of each treatment period. Patients will also be screened for adverse effects via questionnaire at each visit during treatment.
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Timepoint [1]
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8 weeks
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Secondary outcome [1]
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Secondary efficacy end points
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Assessment method [1]
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The secondary end points assessed will include:
* Migraine frequency (number of days with migraine of any severity/month)
* Migraine episode frequency (number of migraine episodes/month)
* Medication frequency (number of days acute headache medication taken/month)
* Headache related impact on quality of life as assessed using the HIT-6
* Cutaneous allodynia as assessed using the ASC-12
* Biomarker levels
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Timepoint [1]
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8 weeks
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Secondary outcome [2]
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Serum biomarker levels
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Assessment method [2]
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To determine if serum levels of the following potential biomarkers are able to differentiate response to treatment with ibudilast: glutamate, calcitonin gene-related peptide, glial fibrillary acidic protein and S100 calcium binding protein ß.
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Timepoint [2]
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8 weeks
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Eligibility
Key inclusion criteria
Men and women aged between 18 to 65 years Migraine with or without aura, as diagnosed according to the second edition International Classification of Headache Disorders (ICHD-II) Onset of migraine before 50 years of age Headache on 15 or more days per month Migraine-like headache on 8 or more days per month, as per the IHS guidelines
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Change in type or dose of migraine prophylactic medication in last 3 months
* Medication overuse headache as diagnosed according to the ICHD-IIR
* Post-traumatic headache as diagnosed according to the ICHD-II
* Other dominant chronic pain condition
* Known active inflammatory diseases such as rheumatoid arthritis
* History of recent cerebrovascular disorder
* Unable to provide written informed consent
* Unable to read and write in English
* Severe psychological/psychiatric disorders
* Recent history of significant trauma, as determined by the Principal Investigator including major surgery within the previous 2 months or major surgery planned during the treatment period
* Recent history of drug or alcohol abuse
* Any clinically significant findings on screening blood sample results
* Current malignancy
* Known hypersensitivity to ibudilast or excipients in Ketas® formulation
* Renal or hepatic impairment, defined as baseline GFR (as calculated by the Cockcroft-Gault equation) of <60 mL/min, LFTs (excluding bilirubin) > 3 times the upper limit of normal or bilirubin > 2 times the upper limit of normal
* For females of childbearing potential:
* Pregnancy
* Lack of adequate contraception (abstinence, double barrier method, intrauterine device, surgical sterilization (self or partner), hormonal contraceptive methods (oral, injected, or implanted)
* Breastfeeding
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2015
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Sample size
Target
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Accrual to date
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Final
33
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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School of Medical sciences, University of Adelaide - Adelaide
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Recruitment postcode(s) [1]
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- Adelaide
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Funding & Sponsors
Primary sponsor type
Other
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Name
Parisa Gazerani
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Address
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Country
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Other collaborator category [1]
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Government body
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Name [1]
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The Ministry of Science, Technology and Innovation, Denmark
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Migraine Research Foundation
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
This will be a double-blind, randomised, placebo-controlled, two period cross over study of ibudilast in the treatment of chronic migraine. For participants resident in Adelaide, South Australia (i.e. "local participants"): The study will involve a screening visit followed by eight visits to the Pain and Anaesthesia Research Clinic (PARC), within the Royal Adelaide Hospital (RAH), for baseline testing, initiation of the study medications and ongoing data collection (one baseline and three study visits during each treatment period). At the baseline visit, blood samples to assess biomarkers (glutamate, calcitonin gene-related peptide, glial fibrillary acidic protein and S100ß) will be taken. Patients will then be randomised (in a 1:1 ratio) to commence either ibudilast or placebo treatment, which will continue for 8 weeks. Subsequently participants will undergo a 4-week washout period. At the end of the washout period a second 8-week treatment block with the alternative treatment will commence. Patients will complete a headache diary daily for at least 4 weeks prior to the baseline visit, throughout the treatment and washout periods and for 4 weeks after treatment ceases. The diary will record headache frequency, duration, intensity, pain characteristics and medication intake for comparison with baseline data. From screening until the final study visit (over a minimum of 6 months) a total of approximately 200 mL in blood samples will be taken from each local participant. For participants located in country or interstate locations: The same study will be undertaken, but instead of attending the Pain and Anaesthesia Research Clinic (PARC), within the Royal Adelaide Hospital (RAH) for screening and study visits, these will be managed remotely through: basic input from the participant's GP during the screening period correspondence with the PI and study staff via registered post, phone or Skype scheduled visits to the nearest pathology collection centre for blood biochemistry and haematology analysis Interstate or country participants will also be exempt from collection of blood samples for biomarker analysis, hence a total of approximately 120 mL of blood samples will be taken from each interstate or country participant.
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Trial website
https://clinicaltrials.gov/study/NCT01389193
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Paul Rolan, MBBS FRACP FFPM MD
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Address
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School of Medical sciences, University of Adelaide, Adelaide, Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01389193
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