Ibudilast in the Treatment of Patients With Chronic Migraine.
Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Parisa Gazerani
Collaborators:
Migraine Research Foundation The Ministry of Science, Technology and Innovation, Denmark