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Repeated GON Injections in CCH

ConditionCluster Headache
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorLeiden University Medical Center

About this trial

Background:

\- The effect of repeated GON-injections has never been studied in a double-blind randomized trial as a prophylactic therapy in a well-documented group of chronic patients. As such, (repeated) GON-injection has not yet found its place in current (inter)national treatment protocols for chronic cluster headache.

Objectives:

\- The primary objective is to determine if repeated GON-injection result in effective control of cluster headache attacks for more days compared to placebo in chronic cluster headache.

Eligibility:

\- Patients will be selected from the LUMC (Leiden University Medical Center) and CWZ (Canisius Wilhelmina Hospital) chronic cluster headache populations, diagnosed based upon the ICHD-3.

Design:

\- Bi-centre, randomized, double-blind, placebo-controlled retention trial with a maximum follow-up of one year.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 and ≤ 70 years

Chronic cluster headache (International Classification of Headache Disorders - third edition; ICHD-3)

Ictal pain must be always at the same side

≥4 weekly attacks of cluster headache in the prospective one-month baseline observation period

Disqualifiers

Contra-indication against, or current use of, corticosteroids

Occipital nerve stimulation (ONS)

Use of anticoagulation medication or a known bleeding disorder

Inability to use an electronic diary to monitor individual attacks and other items

Trial design

Design model

Parallel

Treatments tested in this trial

  • Methylprednisolone

    Drug

    Injection with prednisolon

  • Saline solution

    Drug

    0,9%

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Placebo ArmPlacebo comparator 1 intervention
Group B: Intervention ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

mean number of days, from first injection until discontinuation, study participants remain using study medication (retention rate in survival curve)

Time frame
1 year

Secondary outcomes

1

Frequency of weekly cluster headache attacks vs. baseline

Time frame
1 year
2

Mean duration of attacks vs. baseline

Time frame
1 year
3

Mean severity (1-10) of attacks vs. baseline

Time frame
1 year
4

Proportion of study participants with >50% or 100% reduction in attack frequency vs. baseline

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Leiden University Medical Center

Lead sponsor

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborator

Source ClinicalTrials.gov
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