GON-block in Chronic Migraine: a Randomized, Double- Blin... | NCT02686983

Studies
GON-block in Chronic Migraine: a Randomized, Double- Blind, Placebo-controlled Study

NCT02686983

Sponsor

Jakob Møller Hansen, MD.

Status

Unknown status

Last Update Posted

Feb 23, 2016Estimated

Enrollment

34Estimated

Phase

Phase 4

Conditions

Chronic Migraine

Interventions

Betamethasone and local anesthetic

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Mar 2018Estimated

Completion Date

Jul 2018Estimated

First Submitted Date

Feb 12, 2016

First Submission Date that Met QC Criteria

Feb 19, 2016

First Posted Date

Feb 22, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2016

Last Update Posted Date

Feb 23, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Infiltration of the greater occipital nerve (GON) with local anaesthetics and corticosteroids is a treatment option for cluster headache. Corticosteroids may be helpful in reducing the pain intensity and frequency in chronic migrtaine. This RCT is set up to assess efficacy and safety of sub-occipital steroid injections with local anesthetic in patients with chronic migraine.

Detailed Description

Infiltration of the greater occipital nerve (GON) with local anaesthetics and corticosteroids is a treatment option for cluster headache. In general, there is a marked paucity of evidence concerning GON blocks in migraine. Corticosteroids may be helpful in reducing the pain intensity and frequency in these patients. This is an RCT to assess efficacy and safety of sub-occipital steroid injections with local anesthetic in patients with chronic migraine.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active	Experimental	Betamethasone and local anesthetic.	Drug: Betamethasone and local anesthetic
Placebo	Placebo Comparator	Saline with local anesthetic.	Drug: Betamethasone and local anesthetic

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Betamethasone and local anesthetic	Drug	Infiltration of the greater occipital nerve .	Active Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of migraine days	Number of days fulfilling the ICHD criteria for migraine	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Number of days with severe headache days	Number of days with severe headache days	8 weeks
Medication use	use of medication recorded during the 8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chronic migraine

Exclusion Criteria:

Medication overuse headache

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jakob Møller Hansen	Contact			jamoha01@regionh.dk

Overall Officials

Name	Affiliation	Role
Jakob M Hansen, MD, PhD	Danish Headache Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Danish Headache Center, University of Copenhagen, Faculty of Health Sciences, Department of Neurology, Glostrup Hospital		Glostrup, Copenhagen		2600	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001623	Betamethasone
D000779	Anesthetics, Local

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided