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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Ibudilast in the Treatment of Medication Overuse Headache: A Double-blind, Randomised, Placebo-controlled Pilot Study
Secondary ID [1] 0 0
IBU-002
Secondary ID [2] 0 0
U1111-1119-9613
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medication Overuse 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
Mental Health 0 0 0 0
Addiction
Public Health 0 0 0 0
Other public health

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

Outcomes
Primary outcome [1] 0 0
Headache Index
Timepoint [1] 0 0
2, 4, 8, 24 weeks
Secondary outcome [1] 0 0
Medication frequency
Timepoint [1] 0 0
2, 4, 8, 24 weeks
Secondary outcome [2] 0 0
Headache frequency
Timepoint [2] 0 0
2, 4, 8, 24 weeks
Secondary outcome [3] 0 0
Duration of headache
Timepoint [3] 0 0
2, 4, 8, 24 weeks
Secondary outcome [4] 0 0
Intensity of headache
Timepoint [4] 0 0
2, 4, 8, 24 weeks
Secondary outcome [5] 0 0
Frequency of probable migraine attacks
Timepoint [5] 0 0
2, 4, 8, 24 weeks
Secondary outcome [6] 0 0
Headache related impact on quality of life
Timepoint [6] 0 0
2, 4, 8, 24 weeks
Secondary outcome [7] 0 0
Allodynia symptom checklist score
Timepoint [7] 0 0
2, 4, 8, 24 weeks
Secondary outcome [8] 0 0
Von Frey filament test
Timepoint [8] 0 0
2, 4, 8, 24 weeks
Secondary outcome [9] 0 0
Brush allodynia test
Timepoint [9] 0 0
2, 4, 8, 24 weeks
Secondary outcome [10] 0 0
Response rate
Timepoint [10] 0 0
2, 4, 8, 24 weeks
Secondary outcome [11] 0 0
Relapse rate
Timepoint [11] 0 0
2, 4, 8, 24 weeks

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

Study design
Purpose of the study
Treatment
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
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2013
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Pain and Anaesthesia Research Clinic, Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
University of Adelaide
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of South Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Rolan, MD FRACP
Address 0 0
The University of Adelaide
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Paul Rolan, MD FRACP
Address 0 0
Country 0 0
Phone 0 0
+61 8 8303 4102
Fax 0 0
Email 0 0
paul.rolan@adelaide.edu.au
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/NCT01317992