Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-02-24 @ 5:04 PM
Study NCT ID:
NCT01389193
Status:
COMPLETED
Last Update Posted:
2015-12-29
First Post:
2011-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ibudilast in the Treatment of Patients With Chronic Migraine.
Sponsor:
Parisa Gazerani
Organization:
Study Overview
Official Title:
Targeting Glial Inhibition to Attenuate Chronic Migraine: AN INTERNATIONAL DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED TRIAL OF IBUDILAST
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IBU-003
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| MRF and DRC | OTHER_GRANT | Migraine Research Foundation, Danish Research Council | View |