Ibudilast in the Treatment of Medication Overuse Headache

• Status: Unknown status
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Adelaide
• Collaborator: University of South Australia
• Treatments: Ibudilast

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