Ibudilast in the Treatment of Patients With Chronic Migraine.
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 1

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.
    


Intervention name(s): Ibudilast; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ibudilast 40 mg twice daily oral capsules for a duration of 8 weeks; Placebo 40 mg twice daily oral capsules for a duration of 8 weeks
Other intervention name(s): Ibudilast (Ketas® 10 mg capsules) manufactured by Kyorin Pharmaceuticals.; Pharmaceutical Packaging Professionals, West Thebarton Rd, Thebarton, South Australia
Intervention MeSH terms: Ibudilast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: ibudilast; migraine; glial cell