Overview
Sponsor-declared trial summary
Osteoarthritis of the first carpometacarpal joint
To show that botulinum toxin injection is superior to placebo injection in improving pain in symptomatic trapezometacarpal osteoarthritis at 3 months
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Nice
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 1 Apr 2021 → 14 May 2025
- Decision date (initial)
- 2024-10-18
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517280-23-00
- EudraCT number
- 2020-002127-10
- ClinicalTrials.gov
- NCT04829565
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To show that botulinum toxin injection is superior to placebo injection in improving pain in symptomatic trapezometacarpal osteoarthritis at 3 months
Conditions and MedDRA coding
Osteoarthritis of the first carpometacarpal joint
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.1 | LLT | 10062893 | Rhizarthrosis | 10028395 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Patient >18 years old
- Patient with rhizarthrosis objectified by interrogation, radiography with at least 2 of the following criteria: osteophyte, joint space narrowing, subchondral sclerosis or geode
- Patient who has had an X-ray of the wrist (face, profile and Kapandji incidence) to estimate the severity of the rhizarthrosis.
- Visual analog scale (VAS) of pain > 4
- Failure of well-conducted drug treatments with level 1 and 2 analgesics, anti-inflammatory drugs and orthotic devices
Exclusion criteria 5
- History of surgery of the thumb column
- Patient who has received an intra-articular trapezoidal metacarpal injection of corticoids, botulinum toxin or hyaluronic acid or other product within the last 6 months
- Patient who has received a Botulinum toxin injection at any site within the last 3 months
- Myasthenia or Lambert-Eaton disease, neuromuscular dysfunction, hypersensitivity to incobotulinumtoxin A, severe respiratory disorder or severe swallowing disorder
- Patients with hypersensitivity to botulinum toxin or to any of the excipients (human albumin sucrose)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Evolution of the initial pain by Visual Analogue Scale compared to that measured at 3 months after the injection. Score from 0 to 10. 0 corresponds to the absence of pain and 10 to the maximum imaginable pain.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
XEOMIN 50 unités, poudre pour solution injectable
PRD4171464 · 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
- INTRA-ARTICULAR INJECTION
- Max daily dose
- 50 U unit(s)
- Max total dose
- 50 U unit(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- M03AX01 — BOTULINUM TOXIN
- Marketing authorisation
- 34009 580 887 6 6
- MA holder
- MERZ PHARMACEUTICALS GMBH
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- Route of administration
- INTRA-ARTICULAR INJECTION
- Max daily dose
- 50 U unit(s)
- Max total dose
- 50 U unit(s)
- Max treatment duration
- 1 Day(s)
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Nice
- Sponsor organisation
- Centre Hospitalier Universitaire De Nice
- Address
- 4 Avenue Reine Victoria
- City
- Nice
- Postcode
- 06000
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Nice
- Contact name
- Dr Pierre BLANC Investigateur Principal
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Nice
- Contact name
- Dominique DONZEAU Clinical Trial Manager
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 60 | 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 |
|---|---|---|---|---|---|
| France | 2021-04-01 | 2025-05-14 | 2021-09-15 | 2025-02-03 |
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) | 2020-002127-10_PROTOCOLE_V4-0_20230612 | 4.0 |
| Recruitment arrangements (for publication) | NA_Part II | 0.0 |
| Subject information and informed consent form (for publication) | 2020-002127-10_Carte patiente_TB_V0.2_25082020 | 0.2 |
| Subject information and informed consent form (for publication) | 2020-002127-10_NICE_V3.0_20230612_consolide | 3.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-02 | France | Acceptable 2024-09-07
|
2024-10-18 |