NCT01317992

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2011

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

February 6, 2013

Status Verified

February 1, 2013

Enrollment Period

2.2 years

First QC Date

March 17, 2011

Last Update Submit

February 4, 2013

Conditions

Medication Overuse Headache

Keywords

Medication overuse headacheibudilastglia

Outcome Measures

Primary Outcomes (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.

    2, 4, 8, 24 weeks

Secondary Outcomes (11)

  • Medication frequency

    2, 4, 8, 24 weeks

  • Headache frequency

    2, 4, 8, 24 weeks

  • Duration of headache

    2, 4, 8, 24 weeks

  • Intensity of headache

    2, 4, 8, 24 weeks

  • Frequency of probable migraine attacks

    2, 4, 8, 24 weeks

  • +6 more secondary outcomes

Study Arms (2)

Ibudilast

EXPERIMENTAL

To receive ibudilast 40mg twice daily for 8 weeks.

Drug: Ibudilast

Placebo

PLACEBO COMPARATOR

To receive placebo twice daily for 8 weeks.

Drug: Placebo

Interventions

IbudilastDRUG

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

Ibudilast
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pain and Anaesthesia Research Clinic, Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

RECRUITING

Related Publications (3)

  • 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.

    PMID: 19029522BACKGROUND

  • 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.

    PMID: 17868013BACKGROUND

  • 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.

    PMID: 17982582BACKGROUND

Related Links

MeSH Terms

Conditions

Headache Disorders, Secondary

Interventions

ibudilast

Condition Hierarchy (Ancestors)

Headache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Paul Rolan, MD FRACP

    The University of Adelaide

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Rolan, MD FRACP

CONTACT

+61 8 8303 4102paul.rolan@adelaide.edu.au

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Paul Rolan

Study Record Dates

First Submitted

March 17, 2011

First Posted

March 18, 2011

Study Start

April 1, 2011

Primary Completion

June 1, 2013

Study Completion

August 1, 2013

Last Updated

February 6, 2013

Record last verified: 2013-02

Locations

AU(1)