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Medication Overuse Headache | Ibudilast in the Treatment of Medication Overuse Headache

Medication Overuse Headache research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Medication Overuse Headache

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:IbudilastIbudilast 4 x 10 mg capsules, orally, twice daily for 8 weeks.

Drug:PlaceboPlacebo 4 capsules, orally, twice daily for 8 weeks.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

IbudilastTo receive ibudilast 40mg twice daily for 8 weeks.

PlaceboTo receive placebo twice daily for 8 weeks.

Study Status

Unknown status

Start Date: April 2011

Completed Date: August 2013

Phase: Phase 1/Phase 2

Type: Interventional

Design:

Primary Outcome: Headache Index

Secondary Outcome: Medication frequency

Study sponsors, principal investigator, and references

Principal Investigator: Paul Rolan, MD FRACP

Lead Sponsor: University of Adelaide

Collaborator: University of South Australia

More information:https://clinicaltrials.gov/show/NCT01317992

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. Review.

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