Overview
Sponsor-declared trial summary
Cluster headache
To show that repeated GON-injections are a safe, well-tolerated, convenient, and cost-effective therapy to rapidly and long-term reduce the attack frequency in chronic cluster headache.
Key facts
- Sponsor
- Leids Universitair Medisch Centrum (LUMC)
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 10 Aug 2024 → 8 Apr 2026
- Decision date (initial)
- 2024-08-09
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- ZonMW
External identifiers
- EU CT number
- 2024-514311-10-00
- EudraCT number
- 2021-006687-25
- ClinicalTrials.gov
- NCT05324748
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacoeconomic, Efficacy, Safety
To show that repeated GON-injections are a safe, well-tolerated,
convenient, and cost-effective therapy to rapidly and long-term reduce
the attack frequency in chronic cluster headache.
Secondary objectives 3
- To determine f the effect of one GON-injection predict the effects of subsequent GON-injections.
- The median GON-injection interval.
- The tolerability of repeated GON-injections .
Conditions and MedDRA coding
Cluster headache
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 25.0 | LLT | 10086874 | Chronic cluster headache | 100000004848 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Age ≥18
- 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
Exclusion criteria 7
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Retention rate (= time between the first injection and end-of-treatment; survival curves verum vs. placebo)
Secondary endpoints 12
- Frequency of daily cluster headache attacks
- The use of acute attack medication per day (subcutaneous sumatriptan and 100% oxygen)
- Mean duration and severity (1-10) of attacks
- Injection interval
- Total number of injections in study period
- Proportion of participants still in study at 1 year
- Participants idea: did they receive placebo or verum?
- Physician's idea: did they administer placebo or verum?
- Adverse events + ultrasound structural integrity measurements greater occipital nerve
- Proportion of subjects with a >50% and 100% reduction in attack frequency
- Daily quality of life (EQ 5D)
- Healthcare use & productivity losses
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Depo-Medrone 40 mg/ml Suspension for Injection.
PRD1182064 · Product
- Active substance
- Methylprednisolone Acetate
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 80 mg/ml milligram(s)/millilitre
- Max total dose
- 960 mg/ml milligram(s)/millilitre
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- H02AB04 — METHYLPREDNISOLONE
- Marketing authorisation
- PL 00057/0963
- MA holder
- PFIZER LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
NaCl 0,9 % B. Braun, solution injectable
PRD9621454 · Product
- Active substance
- Sodium Chloride
- Substance synonyms
- SODIUM CHLORID
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 2 ml millilitre(s)
- Max total dose
- 24 ml millilitre(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- V07AB — SOLVENTS AND DILUTING AGENTS, INCL. IRRIGATING SOLUTIONS
- Marketing authorisation
- BE128125
- MA holder
- B.BRAUN MELSUNGEN AG
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Leids Universitair Medisch Centrum (LUMC)
- Sponsor organisation
- Leids Universitair Medisch Centrum (LUMC)
- Address
- Albinusdreef 2
- City
- Leiden
- Postcode
- 2333 ZA
- Country
- Netherlands
Scientific contact point
- Organisation
- Leids Universitair Medisch Centrum (LUMC)
- Contact name
- Rolf Fronczek
Public contact point
- Organisation
- Leids Universitair Medisch Centrum (LUMC)
- Contact name
- Rolf Fronczek
Sponsor responsibilities
- Article 77 implementation
- Leids Universitair Medisch Centrum (LUMC)
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 50 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2024-08-10 | 2026-04-08 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Onderzoeksprotocol NL7966505822 | 5 |
| Recruitment arrangements (for publication) | K1 Recruitment Procedure | 1 |
| Subject information and informed consent form (for publication) | L1 informatiebrief en toestemmingsformulieren_CWZ | 6 |
| Subject information and informed consent form (for publication) | L1 informatiebrief en toestemmingsformulieren_LUMC | 6 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC Methylprednisolon | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-16 | Netherlands | Acceptable with conditions 2024-08-09
|
2024-08-09 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-11 | Netherlands | Acceptable with conditions | 2024-11-26 |