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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
Timepoint [1] 0 0
8 weeks
Secondary outcome [1] 0 0
Secondary efficacy end points
Timepoint [1] 0 0
8 weeks
Secondary outcome [2] 0 0
Serum biomarker levels
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
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
The Ministry of Science, Technology and Innovation, Denmark
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Migraine Research Foundation
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01389193
Trial related presentations / publications
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
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01389193