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.
We will connect you to the doctor responsible for this trial and help you get more information.
Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01317992
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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
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)
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
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:
Lack of adequate contraception (abstinence, double barrier method, intrauterine device, surgical sterilization (self or partner), hormonal contraceptive methods
(oral, injected, or implanted)
All locations for NCT01317992
Adelaide, South Australia, Australia, 5000
Put me in touch!
View full eligibility
Tris trial is registered with FDA with number: NCT01317992. The sponsor of the trial is University of Adelaide and it is looking for 40 volunteers for the current phase.
Official trial title: Ibudilast in the Treatment of Medication Overuse Headache: A Double-blind, Randomised, Placebo-controlled Pilot Study
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