NCT02686983

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 22, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

2 years

First QC Date

February 12, 2016

Last Update Submit

February 22, 2016

Conditions

Chronic Migraine

Outcome Measures

Primary Outcomes (1)

  • Number of migraine days

    Number of days fulfilling the ICHD criteria for migraine

    8 weeks

Secondary Outcomes (4)

  • Number of days with severe headache days

    8 weeks

  • Medication use

    8 weeks

  • Responder rate

    8 weeks

  • Number of migraine attacks

    8 weeks

Study Arms (2)

Active

EXPERIMENTAL

Betamethasone and local anesthetic.

Drug: Betamethasone and local anesthetic

Placebo

PLACEBO COMPARATOR

Saline with local anesthetic.

Drug: Betamethasone and local anesthetic

Interventions

Betamethasone and local anestheticDRUG

Infiltration of the greater occipital nerve .

Also known as: GON block
ActivePlacebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic migraine

You may not qualify if:

  • Medication overuse headache

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Glostrup, Copenhagen, 2600, Denmark

Location

MeSH Terms

Interventions

BetamethasoneAnesthetics, Local

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic Uses

Study Officials

  • Jakob M Hansen, MD, PhD

    Danish Headache Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jakob Møller Hansen

CONTACT

jamoha01@regionh.dk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 12, 2016

First Posted

February 22, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2018

Study Completion

July 1, 2018

Last Updated

February 23, 2016

Record last verified: 2016-02

Locations

DK(1)