Ibudilast in the Treatment of Patients With Chronic Migraine.

Summary

This will be a double-blind, randomised, placebo-controlled, two period cross over study of ibudilast in the treatment of chronic migraine.

For participants resident in Adelaide, South Australia (i.e. "local participants"):

The study will involve a screening visit followed by eight visits to the Pain and Anaesthesia Research Clinic (PARC), within the Royal Adelaide Hospital (RAH), for baseline testing, initiation of the study medications and ongoing data collection (one baseline and three study visits during each treatment period).

At the baseline visit, blood samples to assess biomarkers (glutamate, calcitonin gene-related peptide, glial fibrillary acidic protein and S100β) will be taken. Patients will then be randomised (in a 1:1 ratio) to commence either ibudilast or placebo treatment, which will continue for 8 weeks. Subsequently participants will undergo a 4-week washout period. At the end of the washout period a second 8-week treatment block with the alternative treatment will commence.

Patients will complete a headache diary daily for at least 4 weeks prior to the baseline visit, throughout the treatment and washout periods and for 4 weeks after treatment ceases. The diary will record headache frequency, duration, intensity, pain characteristics and medication intake for comparison with baseline data.

From screening until the final study visit (over a minimum of 6 months) a total of approximately 200 mL in blood samples will be taken from each local participant.

For participants located in country or interstate locations:

The same study will be undertaken, but instead of attending the Pain and Anaesthesia Research Clinic (PARC), within the Royal Adelaide Hospital (RAH) for screening and study visits, these will be managed remotely through:

basic input from the participant's GP during the screening period correspondence with the PI and study staff via registered post, phone or Skype scheduled visits to the nearest pathology collection centre for blood biochemistry and haematology analysis

Interstate or country participants will also be exempt from collection of blood samples for biomarker analysis, hence a total of approximately 120 mL of blood samples will be taken from each interstate or country participant.

Conditions

• Migraine Headache

Interventions

DRUG

Ibudilast

Ibudilast 40 mg twice daily oral capsules for a duration of 8 weeks

DRUG

Placebo

Placebo 40 mg twice daily oral capsules for a duration of 8 weeks

Sponsors & Collaborators

• The Ministry of Science, Technology and Innovation, Denmark

  collaborator OTHER_GOV

• Migraine Research Foundation

  collaborator OTHER

• Parisa Gazerani

  lead OTHER

Principal Investigators

• Paul Rolan, MBBS FRACP FFPM MD · School of Medical sciences, University of Adelaide, Adelaide, Australia

• Parisa Gazerani, PharmD, PhD · Aalborg University

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-06-30

Primary Completion

2015-12-31

Completion

2015-12-31

Countries

• Australia

Study Locations