Ibudilast in the Treatment of Patients With Chronic Migraine.

NCT01389193 | Completed Phase 1 DMC

• 2 other identifiers: IBU-003MRF and DRC
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ibudilast; migraine; glial cell

Outcome Measures

Primary Outcomes (1)

• Primary efficacy end point

  As suggested by the IHS guidelines for clinical trials in chronic migraine, the primary efficacy endpoint will be number of headache days per month with moderate or severe intensity. Study outcomes will be assessed at baseline and at weeks 2, 4 and 8 of each treatment period. To monitor treatment with ibudilast, blood biochemistry (including assessment of renal and hepatic including GGT function) and haematology will be assessed at baseline, and at weeks 2, 4 and 8 of each treatment period. Patients will also be screened for adverse effects via questionnaire at each visit during treatment.

  8 weeks

Secondary Outcomes (2)

• Secondary efficacy end points

  8 weeks

• Serum biomarker levels

  8 weeks

Other Outcomes (1)

• safety and tolerability of ibudilast

  8 weeks

Study Arms (2)

Ibudilast

EXPERIMENTAL

Drug: Ibudilast

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ibudilast DRUG

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

Also known as: Ibudilast (Ketas® 10 mg capsules) manufactured by Kyorin Pharmaceuticals.

Ibudilast

Placebo DRUG

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

Also known as: Pharmaceutical Packaging Professionals, West Thebarton Rd, Thebarton, South Australia

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged between 18 to 65 years Migraine with or without aura, as diagnosed according to the second edition International Classification of Headache Disorders (ICHD-II) Onset of migraine before 50 years of age Headache on 15 or more days per month Migraine-like headache on 8 or more days per month, as per the IHS guidelines

You may not qualify if:

• Change in type or dose of migraine prophylactic medication in last 3 months
• Medication overuse headache as diagnosed according to the ICHD-IIR
• Post-traumatic headache as diagnosed according to the ICHD-II
• Other dominant chronic pain condition
• Known active inflammatory diseases such as rheumatoid arthritis
• History of recent cerebrovascular disorder
• Unable to provide written informed consent
• Unable to read and write in English
• Severe psychological/psychiatric disorders
• Recent history of significant trauma, as determined by the Principal Investigator including major surgery within the previous 2 months or major surgery planned during the treatment period
• Recent history of drug or alcohol abuse
• Any clinically significant findings on screening blood sample results
• Current malignancy
• Known hypersensitivity to ibudilast or excipients in Ketas® formulation
• Renal or hepatic impairment, defined as baseline GFR (as calculated by the Cockcroft-Gault equation) of \<60 mL/min, LFTs (excluding bilirubin) \> 3 times the upper limit of normal or bilirubin \> 2 times the upper limit of normal

Sponsors & Collaborators

• Parisa Gazerani: lead
• The Ministry of Science, Technology and Innovation, Denmark: collaborator
• Migraine Research Foundation: collaborator

Study Sites (1)

School of Medical sciences, University of Adelaide

Adelaide, Australia

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

ibudilast; Capsules

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Paul Rolan, MBBS FRACP FFPM MD

  School of Medical sciences, University of Adelaide, Adelaide, Australia

  PRINCIPAL INVESTIGATOR

• Parisa Gazerani, PharmD, PhD

  Aalborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associtae professor

Study Record Dates

• First Submitted: June 29, 2011
• First Posted: July 8, 2011
• Study Start: June 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 29, 2015

Record last verified: 2015-12

Locations

AU (1)