Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2025-12-24 @ 3:31 PM
NCT ID:
NCT01317992
Eligibility 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
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01317992
Study Brief:
Protocol Section:
NCT01317992