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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01317992
Registration number
NCT01317992
Ethics application status
Date submitted
17/03/2011
Date registered
18/03/2011
Date last updated
6/02/2013
Titles & IDs
Public title
Ibudilast in the Treatment of Medication Overuse Headache
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Scientific title
Ibudilast in the Treatment of Medication Overuse Headache: A Double-blind, Randomised, Placebo-controlled Pilot Study
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Secondary ID [1]
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IBU-002
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Secondary ID [2]
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U1111-1119-9613
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Medication Overuse 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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Mental Health
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Addiction
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Public Health
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Other public health
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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 - To receive ibudilast 40mg twice daily for 8 weeks.
Placebo Comparator: Placebo - To receive placebo twice daily for 8 weeks.
Treatment: Drugs: Ibudilast
Ibudilast 4 x 10 mg capsules, orally, twice daily for 8 weeks.
Treatment: Drugs: Placebo
Placebo 4 capsules, orally, twice daily for 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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Headache Index
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Assessment method [1]
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Headache Index as calculated by the summation of headache duration (hours) X headache intensity (11-point numerical rating scale), over the final two weeks of treatment.
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Timepoint [1]
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2, 4, 8, 24 weeks
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Secondary outcome [1]
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Medication frequency
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Assessment method [1]
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Defined as number of days acute headache medication taken over the previous month.
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Timepoint [1]
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2, 4, 8, 24 weeks
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Secondary outcome [2]
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Headache frequency
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Assessment method [2]
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Defined as number of days with headache over the previous month
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Timepoint [2]
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2, 4, 8, 24 weeks
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Secondary outcome [3]
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Duration of headache
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Assessment method [3]
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Average duration of headache in hours over previous 2 weeks
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Timepoint [3]
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2, 4, 8, 24 weeks
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Secondary outcome [4]
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Intensity of headache
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Assessment method [4]
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Average intensity of headache assessed by numerical rating scale over previous 2 weeks
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Timepoint [4]
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2, 4, 8, 24 weeks
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Secondary outcome [5]
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Frequency of probable migraine attacks
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Assessment method [5]
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Defined as number of probable migraine attacks (using International Classification of Headache Disorders, second edition, criteria for diagnosis of migraine/migraine with aura) over previous month
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Timepoint [5]
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2, 4, 8, 24 weeks
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Secondary outcome [6]
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Headache related impact on quality of life
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Assessment method [6]
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As assessed via the six-item the Headache Impact Test
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Timepoint [6]
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2, 4, 8, 24 weeks
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Secondary outcome [7]
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Allodynia symptom checklist score
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Assessment method [7]
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Assesses presence of cutaneous allodynia during activities of daily living
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Timepoint [7]
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2, 4, 8, 24 weeks
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Secondary outcome [8]
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Von Frey filament test
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Assessment method [8]
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To assess sensitivity to static mechanical cutaneous allodynia
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Timepoint [8]
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2, 4, 8, 24 weeks
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Secondary outcome [9]
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Brush allodynia test
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Assessment method [9]
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To assess sensitivity to dynamic mechanical cutaneous allodynia
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Timepoint [9]
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2, 4, 8, 24 weeks
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Secondary outcome [10]
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Response rate
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Assessment method [10]
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Response defined as = 30% reduction in headache days/month or headache index from baseline. Expressed as percentage of patients who saw a = 30% reduction in headache index after ibudilast treatment (at week 8) and NNT, number of patients treated to see 1 patient "respond".
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Timepoint [10]
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2, 4, 8, 24 weeks
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Secondary outcome [11]
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Relapse rate
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Assessment method [11]
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Expressed as the percentage of patients who were initially classed as responders (at weeks 8) who no longer meet the criteria for responders at 6 months
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Timepoint [11]
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2, 4, 8, 24 weeks
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Eligibility
Key inclusion criteria
Inclusion criteria:
- Regular use, for at least 3 months, of opioid-containing analgesics on = 10 days/month
- Headache present on at least 15 days/month, for at least 2 months
- Headache developed or markedly worsened during medication overuse
- Primary indication for analgesics is headache disorder
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Minimum age
18
Years
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Maximum age
No limit
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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
Exclusion criteria:
- Unable to provide written informed consent
- Age < 18 years at time of screening
- Unable to read and write in English
- Receiving tramadol regularly
- Taking triptans > 4 days/month
- Taking opioids for reasons other than headache (e.g. other pain conditions, cough,
bowel motility)
- Severe psychiatric disorders
- Other chronic pain conditions likely to interfere with qualitative sensory testing
(e.g. trigeminal neuralgia, arthritis)
- Diabetic neuropathy
- Recent or current active infection, determined to be clinically significant by the
Principal investigator
- Known active inflammatory diseases such as rheumatoid arthritis
- History of cerebrovascular disorder
- Recent history of significant trauma, as determined by the Principal Investigator
including major surgery within the previous 2 months
- Recent history of drug or alcohol abuse
- Spinal cord injury
- Any clinically significant findings on screening blood sample results
- Current malignancy
- Known hypersensitivity to ibudilast or excipients in Pinatos® formulation
- Renal or hepatic impairment, defined as baseline GFR (as calculated by the
Cockcroft-Gault equation) of < 60 mL/min or LFTs > 3 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
Treatment
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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/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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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
1/04/2011
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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
1/08/2013
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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Pain and Anaesthesia Research Clinic, Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Adelaide
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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University of South Australia
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine if ibudilast is effective in reverting patients
with medication overuse headache suffering chronic daily headache back to their original
episodic headache pattern.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01317992
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Trial related presentations / publications
Bigal ME, Lipton RB. Excessive acute migraine medication use and migraine progression. Neurology. 2008 Nov 25;71(22):1821-8. doi: 10.1212/01.wnl.0000335946.53860.1d.
Obermann M, Katsarava Z. Management of medication-overuse headache. Expert Rev Neurother. 2007 Sep;7(9):1145-55. doi: 10.1586/14737175.7.9.1145.
Hutchinson MR, Bland ST, Johnson KW, Rice KC, Maier SF, Watkins LR. Opioid-induced glial activation: mechanisms of activation and implications for opioid analgesia, dependence, and reward. ScientificWorldJournal. 2007 Nov 2;7:98-111. doi: 10.1100/tsw.2007.230.
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Public notes
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Contacts
Principal investigator
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Paul Rolan, MD FRACP
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Address
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The University of Adelaide
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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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Paul Rolan, MD FRACP
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Address
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Country
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Phone
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+61 8 8303 4102
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01317992
Download to PDF