BoNT in stroke

Start 14 Aug 2025 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Phase III and Phase IV (Integrated)

Status Ongoing, recruiting

Participants planned 12

Countries 1

Sites 1

spastic equinovarus in stroke patients

To conduct a pilot study as guidance for a future observational study to evaluate changes in muscle, tendon and neural properties after botulinum neurotoxin-A (BoNT) treatment of spastic equinovarus in first-ever stroke patients by using Three Dimensional freehand Ultrasound (3DfUS) and Instrumented Spasticity Assessme…

Key facts

Sponsor: UZ Leuven
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trial duration: 14 Aug 2025 → ongoing
Decision date (initial): 2024-12-02
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No
Funding sources: UZ Leuven

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

Conditions and MedDRA coding

spastic equinovarus in stroke patients

Regulatory references

Plan to share IPD: No

EU CT number	Title	Sponsor
2024-513158-32-00	Exploratory, longitudinal study to define changes in muscle, tendon and neural properties after botuline neurotoxin type A (BoNT) treatment of spastic equinovarus in first-ever stroke patients: a pilot study	UZ Leuven

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

Participants eligible for inclusion in this Trial must meet all of the following criteria
1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
2. At least 18 years of age at the time of signing the Informed Consent Form (ICF)
3. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.
4. Pes equinovarus due to spasticity
5. Clinical need for BoNT injection at the lower leg
6. Any previous injection of BoNT into the muscles to be investigated was at least 3 months ago
7. First-ever, unilateral stroke

Exclusion criteria 7

1. Musculoskeletal or other neurological problems affecting the lower limb
2. Presence of spinal cord pathology that could lead to spasticity, ataxia, dystonia
3. Cognitive problems that impede measurements
4. Severe co-morbidities
5. Irritated skin or open wounds where ultrasound will be placed
6. Pregnancy
7. Profound atrophy of the muscles in the target area(s) of injection

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1) Primary outcome parameters measured by 3DfUS muscle volume.
2) Primary outcome parameters measured by ISA The primary outcome parameter to determine the neural contributions to hyperresistance will be derived from the fast stretch: muscle activity (root mean square (RMS) EMG [uV].

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Dysport 500 U, poudre pour solution injectable

PRD10857175 · Product

Active substance: Botulinum Toxin Type a - Haemagglutinin Complex
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAMUSCULAR INJECTION
Max daily dose: 1500 U unit(s)
Max total dose: 1500 U unit(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: M03AX01 — BOTULINUM TOXIN
Marketing authorisation: 0312509
MA holder: IPSEN N.V.
MA country: Luxembourg
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Leuven

Sponsor organisation: UZ Leuven
Address: Herestraat 49
City: Leuven
Postcode: 3000
Country: Belgium

Scientific contact point

Organisation: UZ Leuven
Contact name: Ethische commissie onderzoek

Public contact point

Organisation: UZ Leuven
Contact name: Ethische commissie onderzoek

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Belgium	Ongoing, recruiting	12	1
Rest of world	—	0	—

Investigational sites

Belgium

1 site · Ongoing, recruiting

UZ Leuven

Physical Medicine and Rehabilitation, Herestraat 49, 3000, Leuven

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
Belgium	2025-08-14		2025-08-14

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_Protocol 2024-513158-32-01	1
Recruitment arrangements (for publication)	K1_Recruitment arrangements	1
Subject information and informed consent form (for publication)	L1_SIS and ICF adults nl	2.0
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Dysport	1
Synopsis of the protocol (for publication)	D1_Protocol synopsis MS EN NL FR DE 2024-513158-32-01	1

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	Belgium	Acceptable 2024-11-22	2024-12-02