Ibudilast in the Treatment of Medication Overuse Headache
- Registration Number
- NCT01317992
- Lead Sponsor
- University of Adelaide
- Brief 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.
- Detailed Description
It has been established that excessive intake of medications used to treat primary headaches, particularly those containing opioids, can induce a form of secondary headache, known as medication overuse headache (MOH). Despite the significant clinical impact of this condition the mechanisms behind MOH remain poorly understood, guidelines for treatment are lacking, and relapse is common.
Recently, it has been recognised that repeated opioid exposure can facilitate pain by activating glia, the immunocompetent cells of the central nervous system, resulting in opioid-induced hyperalgesia (OIH).
The investigators hypothesise that MOH represents a form of OIH in this susceptible patient group - repeated activation of nociceptive pathways by frequent headaches interacts with the opioid induced pro-inflammatory actions of activated glia to produce chronic daily headache (CDH).
This double-blind, randomised, placebo controlled pilot study will investigate the use of ibudilast, a know attenuator of glial activation, in the treatment of medication overuse headache.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ibudilast Ibudilast To receive ibudilast 40mg twice daily for 8 weeks. Placebo Placebo To receive placebo twice daily for 8 weeks.
- Primary Outcome Measures
Name Time Method Headache Index 2, 4, 8, 24 weeks Headache Index as calculated by the summation of headache duration (hours) X headache intensity (11-point numerical rating scale), over the final two weeks of treatment.
- Secondary Outcome Measures
Name Time Method Medication frequency 2, 4, 8, 24 weeks Defined as number of days acute headache medication taken over the previous month.
Headache frequency 2, 4, 8, 24 weeks Defined as number of days with headache over the previous month
Duration of headache 2, 4, 8, 24 weeks Average duration of headache in hours over previous 2 weeks
Intensity of headache 2, 4, 8, 24 weeks Average intensity of headache assessed by numerical rating scale over previous 2 weeks
Frequency of probable migraine attacks 2, 4, 8, 24 weeks Defined as number of probable migraine attacks (using International Classification of Headache Disorders, second edition, criteria for diagnosis of migraine/migraine with aura) over previous month
Headache related impact on quality of life 2, 4, 8, 24 weeks As assessed via the six-item the Headache Impact Test
Allodynia symptom checklist score 2, 4, 8, 24 weeks Assesses presence of cutaneous allodynia during activities of daily living
Von Frey filament test 2, 4, 8, 24 weeks To assess sensitivity to static mechanical cutaneous allodynia
Brush allodynia test 2, 4, 8, 24 weeks To assess sensitivity to dynamic mechanical cutaneous allodynia
Response rate 2, 4, 8, 24 weeks Response defined as ≥ 30% reduction in headache days/month or headache index from baseline. Expressed as percentage of patients who saw a ≥ 30% reduction in headache index after ibudilast treatment (at week 8) and NNT, number of patients treated to see 1 patient "respond".
Relapse rate 2, 4, 8, 24 weeks Expressed as the percentage of patients who were initially classed as responders (at weeks 8) who no longer meet the criteria for responders at 6 months
Trial Locations
- Locations (1)
Pain and Anaesthesia Research Clinic, Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia