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Medication Overuse HeadachePhase 1/2NCT01317992

Ibudilast in the Treatment of Medication Overuse Headache

A Phase 1/2 study testing Ibudilast in people with Medication Overuse Headache, run by University of Adelaide at 1 site in Australia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Medication Overuse Headache
What is being tested?
Ibudilast
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteAustralia
Study dates
Apr 2011to Aug 2013
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 23Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Paul Rolan, MD FRACP contact

+61 8 8303 4102

paul.rolan@adelaide.edu.au

Australia1 site, 1 recruiting

  • Pain and Anaesthesia Research Clinic, Royal Adelaide Hospital

    Adelaide, South Australia, 5000

    Recruiting

Other trials in Australia

About this study

Official title: Ibudilast in the Treatment of Medication Overuse Headache: A Double-blind, Randomised, Placebo-controlled Pilot 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.

Read the 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.

Being tested
Ibudilast, Placebo
Keywords
Medication overuse headache, ibudilast, glia
Medical subject headings
Headache Disorders, Secondary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IbudilastDrug

    Ibudilast 4 x 10 mg capsules, orally, twice daily for 8 weeks.

  • PlaceboDrug

    Placebo 4 capsules, orally, twice daily for 8 weeks.

Study groups in NCT01317992
Study groupRoleWhat they receive
IbudilastExperimentalTo receive ibudilast 40mg twice daily for 8 weeks.
Receives: Drug: Ibudilast
PlaceboPlacebo comparatorTo receive placebo twice daily for 8 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Headache Index

    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.

    Measured: 2, 4, 8, 24 weeks

Secondary outcomes (11)

  1. Medication frequency

    Defined as number of days acute headache medication taken over the previous month.

    Measured: 2, 4, 8, 24 weeks

  2. Headache frequency

    Defined as number of days with headache over the previous month

    Measured: 2, 4, 8, 24 weeks

  3. Duration of headache

    Average duration of headache in hours over previous 2 weeks

    Measured: 2, 4, 8, 24 weeks

  4. Intensity of headache

    Average intensity of headache assessed by numerical rating scale over previous 2 weeks

    Measured: 2, 4, 8, 24 weeks

  5. Frequency of probable migraine attacks

    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

    Measured: 2, 4, 8, 24 weeks

  6. Headache related impact on quality of life

    As assessed via the six-item the Headache Impact Test

    Measured: 2, 4, 8, 24 weeks

  7. Allodynia symptom checklist score

    Assesses presence of cutaneous allodynia during activities of daily living

    Measured: 2, 4, 8, 24 weeks

  8. Von Frey filament test

    To assess sensitivity to static mechanical cutaneous allodynia

    Measured: 2, 4, 8, 24 weeks

  9. Brush allodynia test

    To assess sensitivity to dynamic mechanical cutaneous allodynia

    Measured: 2, 4, 8, 24 weeks

  10. Response rate

    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".

    Measured: 2, 4, 8, 24 weeks

  11. Relapse rate

    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

    Measured: 2, 4, 8, 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionJun 2013 (estimated)
  4. Study completionAug 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01317992
Sponsor's protocol ID
U1111-1119-9613
Other IDs
IBU-002
Status last verified
Feb 2013
First submitted
17 Mar 2011
Last updated
6 Feb 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19029522

  • Obermann M, Katsarava Z. Management of medication-overuse headache. Expert Rev Neurother. 2007 Sep;7(9):1145-55. doi: 10.1586/14737175.7.9.1145.

    PubMed 17868013

  • Hutchinson MR, Bland ST, Johnson KW, Rice KC, Maier SF, Watkins LR. Opioid-induced glial activation: mechanisms of activation and implications for opioid analgesia, dependence, and reward. ScientificWorldJournal. 2007 Nov 2;7:98-111. doi: 10.1100/tsw.2007.230.

    PubMed 17982582

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ibudilast in people with Medication Overuse Headache, run by University of Adelaide at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Paul Rolan, MD FRACP (+61 8 8303 4102, paul.rolan@adelaide.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Headache Index (time frame: 2, 4, 8, 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01317992, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2013.

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