Overview
Sponsor-declared trial summary
patients with head and neck squamous cell carcinoma (HNSCC)
To evaluate whether intraglandular application of botulinum toxin type A prior to radiotherapy preserves salivary gland function.
Key facts
- Sponsor
- Fakultni Nemocnice Kralovske Vinohrady
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Otorhinolaryngologic Diseases [C09]
- Decision date (initial)
- 2026-06-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
To evaluate whether intraglandular application of botulinum toxin type A prior to radiotherapy preserves salivary gland function.
Secondary objectives 3
- To assess the effect of BoNT/A on quantitative salivary secretion
- To evaluate patient-reported xerostomia and quality of life
- To assess the safety and tolerability of intraglandular BoNT/A application
Conditions and MedDRA coding
patients with head and neck squamous cell carcinoma (HNSCC)
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Age ≥ 18 years
- Histologically confirmed head and neck squamous cell carcinoma indicated for radiotherapy
- Symmetrical function of submandibular glands on pre-treatment Tc99m scintigraphy
- Signed informed consent
Exclusion criteria 5
- Previous radiotherapy to the head and neck region
- Known salivary gland disease (e.g., sialolithiasis, recurrent sialadenitis)
- Pregnancy or lactation
- Known allergy to botulinum toxin or neuromuscular transmission disorders
- Prior surgery affecting major salivary glands (to be evaluated individually)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change in salivary gland function assessed by dynamic Tc99m scintigraphy (excretory fraction), comparing values before and after radiotherapy (biomarker of gland function).
Secondary endpoints 5
- Quantitative change in salivary secretion measured by Škach’s test (stimulated and unstimulated) (biomarker of gland function).
- Change in ultrasound parameters of salivary glands (gland volume and echostructure) (biomarker of gland structure).
- Patient-reported xerostomia assessed by the Xerostomia Questionnaire (XQ).
- Quality of life assessed by EORTC QLQ-C30.
- Safety and tolerability of BoNT/A assessed by: (i) incidence of adverse events related to BoNT/A, (ii) severity of adverse events (CTCAE grading), (iii) occurrence of local complications at the injection site.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
BOTOX 100 jednotek definovaných dle Allerganu prášek pro injekční roztok
PRD10008687 · Product
- Active substance
- Botulinum Toxin Type A
- Substance synonyms
- Onaclostox, Botulinum toxin, type A, purified neurotoxin component, OnabotulinumtoxinA, BOTULINUM TOXIN A, BOTULIN TOXIN A
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 2 ml millilitre(s)
- Max total dose
- 2 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- M03AX01, D11AX — BOTULINUM TOXIN, OTHER DERMATOLOGICALS
- Marketing authorisation
- 63/568/93-C
- MA holder
- ABBVIE S.R.O. (CZECH REPUBLIC)
- MA country
- Czech Republic
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fakultni Nemocnice Kralovske Vinohrady
- Sponsor organisation
- Fakultni Nemocnice Kralovske Vinohrady
- Address
- Srobarova 1150/50, Vinohrady Vinohrady
- City
- Prague
- Postcode
- 100 00
- Country
- Czechia
Scientific contact point
- Organisation
- Fakultni Nemocnice Kralovske Vinohrady
- Contact name
- MUDr. Ľudmila Verešpejová
Public contact point
- Organisation
- Fakultni Nemocnice Kralovske Vinohrady
- Contact name
- Prof. MUDr. Petr Toušek, Ph.D., FESC
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Authorised, recruitment pending | 40 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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_PROBOT_protocol_version 1-2_14-05-2026_clean | 1.2 |
| Recruitment arrangements (for publication) | K1_PROBOT_sablona 1 | 1 |
| Subject information and informed consent form (for publication) | L1_PROBOT_ICF_version 1-0_19-11-2025 | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_PROBOT_souhrn udaju o pripravku BOTOX 100 | 1 |
| Synopsis of the protocol (for publication) | D2_PROBOT_synopse_verze 1-1_23-03-2026 | 1.1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-31 | Czechia | Acceptable 2026-06-02
|
2026-06-02 |