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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.
Scientific title
Targeting Glial Inhibition to Attenuate Chronic Migraine: AN INTERNATIONAL DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED TRIAL OF IBUDILAST
Secondary ID [1] 0 0
MRF and DRC
Secondary ID [2] 0 0
IBU-003
Universal Trial Number (UTN)
Trial acronym
IBU-003
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Migraine Headache 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary efficacy end point
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
8 weeks
Secondary outcome [1] 0 0
Secondary efficacy end points
Assessment method [1] 0 0
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
Timepoint [1] 0 0
8 weeks
Secondary outcome [2] 0 0
Serum biomarker levels
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
8 weeks

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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2015
Sample size
Target
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
School of Medical sciences, University of Adelaide - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
Parisa Gazerani
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
The Ministry of Science, Technology and Innovation, Denmark
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Migraine Research Foundation
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Paul Rolan, MBBS FRACP FFPM MD
Address 0 0
School of Medical sciences, University of Adelaide, Adelaide, Australia
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
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