Repeated GON Injections in CCH

NCT05324748 | Recruiting Phase 3 DMC

• 1 other identifier: 79665
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cluster Headache

Keywords

GON-injection

Outcome Measures

Primary Outcomes (1)

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

  1 year

Secondary Outcomes (7)

• Frequency of weekly cluster headache attacks vs. baseline

  1 year

• Mean duration of attacks vs. baseline

  1 year

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

  1 year

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

  1 year

• Median injection interval

  1 year

Study Arms (2)

Placebo Arm

PLACEBO COMPARATOR

Drug: Saline solution

Intervention Arm

EXPERIMENTAL

Drug: Methylprednisolone

Interventions

Methylprednisolone DRUG

Injection with prednisolon

Intervention Arm

Saline solution DRUG

0,9%

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• On a stable regimen of cluster headache prophylactics for \>4 weeks prior to onset of study treatment and agreeing not to increase the dose and not starting a new cluster prophylactic during the study period

You may not qualify if:

• 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
• Other headaches if the patient cannot reliably distinguish them from attacks of cluster headache
• Current use of prophylactic medication for other headaches
• Pregnancy

Sponsors & Collaborators

• Leiden University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (2)

Leiden University Medical Center

Leiden, Netherlands

RECRUITING

Canisius Wilhelmina Ziekenhuis

Nijmegen, Netherlands

RECRUITING

MeSH Terms

Conditions

Cluster Headache

Interventions

Methylprednisolone; Saline Solution

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Willemijn Naber

CONTACT

0715262587; w.c.naber@lumc.nl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Bi-centre, randomized, double-blind, placebo-controlled retention trial

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 12, 2022
• Study Start: November 7, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-02

Locations

NL (2)