Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
36
Countries
1
Sites
1
piriformis hypertonia
Primary Objective: Sports resumption after BoNT-A injection.
Key facts
- Sponsor
- Stichting Alrijne Zorggroep
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Decision date (initial)
- 2023-11-30
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
Primary Objective: Sports resumption after BoNT-A injection.
Secondary objectives 1
- Secondary objective: Quality of life after injection, pain score (VAS)
Conditions and MedDRA coding
piriformis hypertonia
Regulatory references
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-504427-61-00 | BB trial; Effect of botox in Piriformis syndrome | Stichting Alrijne Zorggroep |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- - Positive effect of the test block with lidocaine and methylprednisolone - Age between 18-60 years old - Active participation in a sport where walking may also be considered
Exclusion criteria 1
- - Botox injection in the piriformis less than three months ago - Other injections in the piriformis less than three months ago
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Subjects that are withdrawn from treatment will be seen in the outpatient clinic 12 weeks after de test block.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB13117MIG · Substance
- Active substance
- Botulinum Toxin Type A
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- INJECTABLE SOLUTION
- Max daily dose
- 100 tuberculin unit tuberculin unit(s)
- Max total dose
- 100 tuberculin unit tuberculin unit(s)
- Max treatment duration
- 20 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- 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
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Stichting Alrijne Zorggroep
- Sponsor organisation
- Stichting Alrijne Zorggroep
- Address
- Simon Smitweg 1
- City
- Leiderdorp
- Postcode
- 2353 GA
- Country
- Netherlands
Scientific contact point
- Organisation
- Stichting Alrijne Zorggroep
- Contact name
- Menno Benard
Public contact point
- Organisation
- Stichting Alrijne Zorggroep
- Contact name
- Menno Benard
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Stichting Alrijne Zorggroep ORG-100044549
|
Leiderdorp, Netherlands | Code 11, Code 13, Code 14, Code 2, Code 5, Data management, Code 8 |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 36 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Stichting Alrijne Zorggroep
Sports medicine, Simon Smitweg 1, 2353 GA, Leiderdorp
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-30 | Netherlands | Acceptable 2023-11-30
|
2023-11-30 |