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

NCT ID: NCT02686983

Last Updated: 2016-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Migraine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active

Betamethasone and local anesthetic.

Group Type EXPERIMENTAL

Betamethasone and local anesthetic

Intervention Type DRUG

Infiltration of the greater occipital nerve .

Placebo

Saline with local anesthetic.

Group Type PLACEBO_COMPARATOR

Betamethasone and local anesthetic

Intervention Type DRUG

Infiltration of the greater occipital nerve .

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Betamethasone and local anesthetic

Infiltration of the greater occipital nerve .

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

GON block

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Chronic migraine

Exclusion Criteria

* Medication overuse headache
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jakob Møller Hansen, MD.

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jakob Møller Hansen, MD.

MD, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jakob M Hansen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Danish Headache Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Danish Headache Center, University of Copenhagen, Faculty of Health Sciences, Department of Neurology, Glostrup Hospital

Glostrup, Copenhagen, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jakob Møller Hansen

Role: CONTACT

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DHC-GON-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Anesthetic Blockades and Migraine
NCT02188394 COMPLETED PHASE2
Efficacy of GONB in Patients of Migraine
NCT05679765 COMPLETED PHASE4
Predictors of GON Blockade Success in Migraine
NCT07170111 NOT_YET_RECRUITING NA