Overview
Sponsor-declared trial summary
brain damage oriented spasticity
To determine the efficacy and safety of the administration of IncobotulinumtoxinA at individualized doses, selected based on the individual needs of patients (spasticity patterns) with severe spasticity and involvement of the upper and lower limbs.
Key facts
- Sponsor
- Dra. Nuria Gutierrez Dubón
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 3 May 2023 → ongoing
- Decision date (initial)
- 2024-10-02
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517668-51-01
- EudraCT number
- 2022-004127-40
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
To determine the efficacy and safety of the administration of IncobotulinumtoxinA at individualized doses, selected based on the individual needs of patients (spasticity
patterns) with severe spasticity and involvement of the upper and lower limbs.
Secondary objectives 1
- Not described
Conditions and MedDRA coding
brain damage oriented spasticity
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-517668-51-00 | Clinical trial on the effectiveness and safety of botulinum toxin type A (incobotulinumtoxin) in doses adapted to the individual needs of patients with severe spasticity | Dra. Nuria Gutierrez Dubón |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Patients older than 18 years
- with a diagnosis of severe multifocal spasticity of the upper and lower limbs due to acquired brain damage
- Who need treatment with IncobotulinumtoxinA at a dose equal to or greater than 800U
- That they agree to participate in the study and sign the informed consent
- With pain assessment data (VAS scale), muscle tone (Asworth scale), and Barthel scale during the follow-up evaluation.
- No contraindications for treatment with botulinum toxin
Exclusion criteria 2
- Patients with severe systemic diseases and active infection
- Pregnant patients or under lactating period.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Asworth scale at 6 weeks of treatment
Secondary endpoints 5
- Pain: Variation on the VAS scale (0-10) at 6 and 12 weeks of treatment
- Effect on the Asworth scale at 12 weeks from drug infiltration
- Barthel scale at 6 and 12 weeks after injection
- Satisfaction with treatment
- Assess the safety and tolerability of the treatment
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
XEOMIN 50 unidades polvo para solución inyectable
PRD10941714 · Product
- Active substance
- Clostridium Botulinum Neurotoxin Type a (150KD), Free of Complexing Proteins
- Substance synonyms
- IncobotulinumtoxinA, NT 201, Botulinum toxin type A (150 kD), free from complexing proteins
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 800 IU international unit(s)
- Max total dose
- 800 IU international unit(s)
- Max treatment duration
- 800 Day(s)
- Authorisation status
- Authorised
- ATC code
- M03AX01 — BOTULINUM TOXIN
- Marketing authorisation
- 74067
- MA holder
- MERZ PHARMACEUTICALS GMBH
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB13117MIG · Substance
- Active substance
- Botulinum Toxin Type A
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 800 IU international unit(s)
- Max total dose
- 800 IU international unit(s)
- Max treatment duration
- 3 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Dra. Nuria Gutierrez Dubón
- Sponsor organisation
- Dra. Nuria Gutierrez Dubón
- Address
- Plaça Poligono 38, 1
- City
- Serra (Valencia9
- Postcode
- 46118
- Country
- Spain
Scientific contact point
- Organisation
- Dra. Nuria Gutierrez Dubón
- Contact name
- Nuria Gutiérrez
Public contact point
- Organisation
- Dra. Nuria Gutierrez Dubón
- Contact name
- Nuria Gutiérrez
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 30 | 1 |
| 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 |
|---|---|---|---|---|---|
| Spain | 2023-05-03 | 2023-07-20 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocolo Ensayo Clinico H Dr Moliner v4 FINAL | 4.0 |
| Recruitment arrangements (for publication) | K_recruitments arrangements in cover letter | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC XEOMIN | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-20 | Spain | Acceptable 2024-10-02
|
2024-10-02 |