Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
60
Countries
2
Sites
2
Spasticity after Stroke
To understand the effects that BTX A and Dry Needling have on post-stroke spasticity in the lower limbs at the spinal level
Key facts
- Sponsor
- University Of Antwerp
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Musculoskeletal and Neural Physiological Phenomena [G11], Diseases [C] - Musculoskeletal Diseases [C05], Diseases [C] - Nervous System Diseases [C10], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]
- Trial duration
- 21 Feb 2025 → ongoing
- Decision date (initial)
- 2024-07-15
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-510866-18-00
- ClinicalTrials.gov
- NCT06296082
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy, Safety, Pharmacodynamic
To understand the effects that BTX A and Dry Needling have on post-stroke spasticity in the lower limbs at the spinal level
Secondary objectives 1
- to assess their safety, feasibility, muscle and functional level effects, quality of life, and cost-effectiveness
Conditions and MedDRA coding
Spasticity after Stroke
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- aged 18-85 years old
- having lower limb post-stroke spasticity in ankle plantar flexors (MAS scores of 1, 1+ and 2);
- having had a first stroke
- having no more than 12 months of evolution since stroke; 5) having no previous Dry Needling (DN) or Botulinum Toxin type A (BTX A) treatment for spasticity
- having ankle PROM ≥ 20° (approx.) when the knee is supported in ~30° flexion
- being able to walk independently with or without aids
- having no previous Dry Needling (DN) or Botulinum Toxin type A (BTX A) treatment for spasticity
Exclusion criteria 4
- medical conditions interfering with data interpretation
- any contraindication to receiving BTX A or PS treatment
- If taking anti-spasticity medications, participants must be on stable medication for at least 3 months prior to the start of the study and neither the dose nor the medication can be changed during the trial
- Pregnancy and/or Breastfeeding
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Spasticity: it will be measured with the Tonic Stretch Reflex Threshold and its velocity sensitivity. It will be assessed weekly during 15 weeks (in week 3, two assessments will be conducted- one before the treatment and one after) and on the 19th week
Secondary endpoints 7
- Resistance to passive stretching: measured with the Modified Ashworth Scale (MAS) It will be assessed weekly during 15 weeks and on the 19th week (in week 3, two assessments will be conducted- one before the treatment and one after).
- Gait: measured with instrumented gait analysis and the 10 Meter Walk Test (10MWT). It will be assessed on week 1, 2, 9, 15 and 19
- Functional mobility: measured with the Time Up and Go (TUG). Assessed on week 1, 2, 9, 15 and 19
- Muscle ultrasound (morphometric and densitometric variables): measured with ultrasound imaging. Assessed every week from 1 to 15 and on the 19 week (in week 3, two assessments will be conducted - one before the treatment and one after)
- Quality of life: measured with the EuroQoL-5D. Assessed on week 1, 15 and 19
- Cost-effectiveness: measured with a cost-effectiveness analysis. It will be done after every intervention session (from 3 to 15 week and on 19)
- sample size, recruitment, and consent rates will be determined, as well as the safety and feasibility of both treatments
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
BOTOX 50 Allergan Units Powder for solution for injection
PRD9600256 · 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
- INTRAMUSCULAR INJECTION
- Max daily dose
- 400 U/ml unit(s)/millilitre
- Max total dose
- 400 U/ml unit(s)/millilitre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- M03AX01, D11AX — BOTULINUM TOXIN, OTHER DERMATOLOGICALS
- Marketing authorisation
- PL 41042/0059
- MA holder
- ABBVIE LTD (UK)
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
BOTOX 100 Allergan Units Powder for solution for injection
PRD9600254 · 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
- INTRAMUSCULAR INJECTION
- Max daily dose
- 400 U/ml unit(s)/millilitre
- Max total dose
- 400 U/ml unit(s)/millilitre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- M03AX01, D11AX — BOTULINUM TOXIN, OTHER DERMATOLOGICALS
- Marketing authorisation
- PL 41042/0057
- MA holder
- ABBVIE LTD (UK)
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
University Of Antwerp
- Sponsor organisation
- University Of Antwerp
- Address
- Universiteitsplein 1
- City
- Antwerp
- Postcode
- 2610
- Country
- Belgium
Locations
2 EU/EEA countries · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 30 | 1 |
| Spain | Authorised, 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 |
|---|---|---|---|---|---|
| Belgium | 2024-09-18 | 2024-09-23 | |||
| Spain | 2025-05-21 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-69283
- Halt date
- 2025-01-30
- Planned restart
- 2025-03-10
- Member states concerned
- Belgium
- Publication date
- 2025-02-05
- Reason
- Sponsor decision
- Explanation
- On 24/07/2024, an amendment was submitted to include a clinical trial location in Belgium: AZ Voorkempen (recruiting center). On 05/02/2025 the amendment was further updated to include the adapted patient documentation referenced in the conditional approval received on 15/07/2024.
This submission was delayed due to a misunderstanding in interpreting the conditional approval letter and occurred after patients had been included. Before the inclusion of any patients at the Revarte site, the comments in the conditional approval letter received on 15/07/2024 were incorporated into the informed consent forms used for the 4 patients included and uploaded to CTIS on 05/02/2025. However, the modifications were not resubmitted afterward due to a misinterpretation of the approval letter, as well as delays in the substantial modification of AZ Voorkempen caused by difficulties in creating a CTIS account for AZ Voorkempen.
With the submission of these patient documents on 05/02/2025, four patients have now been included, with the first ICF signed on 23/09/2024. The site initiation visit was performed on 26/07/2024, and a green light to start the trial was sent to the site on 18/09/2024 (for details see attached documents). However, the inclusion has been on hold since 30/01/2025 until we receive your approval to restart. - Follow-up measures
- Study on hold for future new patients.
willing to implement any corrective measures proposed by CTIS. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 27 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Recruitment arrangements - Extract (for publication) | B1_Cover letter_SM_2024-510866-18-00 V1 | 1 |
| Recruitment arrangements - Extract (for publication) | K1_Recruitment_arrangement_HCULB_tc V1 | 1 |
| Recruitment arrangements - Extract (for publication) | K2_Recruitment material informational poster V1 | 1 |
| Recruitment arrangements (for publication) | K1_1_Recruitment arrangement | 2 |
| Recruitment arrangements (for publication) | K1_1_Recruitment arrangement_trackchanges | 2 |
| Recruitment arrangements (for publication) | K1_2_Recruitment arrangement BE SM tc | 4.0 |
| Recruitment arrangements (for publication) | K1_2_Recruitment arrangements BE SM | 4 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment_arrangement | 1 |
| Recruitment arrangements (for publication) | Recruitment arrangement BE | 1 |
| Recruitment arrangements (for publication) | Recruitment_arrangement_Spain | 1 |
| Subject information and informed consent form (for publication) | Consentimiento informado | 1 |
| Subject information and informed consent form (for publication) | Hoja de Informacion al paciente- Consentimiento Informado | 1 |
| Subject information and informed consent form (for publication) | ICF | 1 |
| Subject information and informed consent form (for publication) | ICF | 1 |
| Subject information and informed consent form (for publication) | L1_1_SIS and ICF | 3.0 |
| Subject information and informed consent form (for publication) | L1_1_SIS and ICF_trackchanges | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material patient brochure | 1 |
| Subject information and informed consent form (for publication) | L2_2 Other subject information material patient brochure | 2.0 |
| Subject information and informed consent form (for publication) | L2_2 Other subject information material patient brochure_AZ voorkempen | 3 |
| Subject information and informed consent form (for publication) | L2_2 Other subject information material patient brochure_AZ voorkempen_tc | 3.0 |
| Subject information and informed consent form (for publication) | L2_2 Other subject information material patient brochure_tc | 2 |
| Subject information and informed consent form (for publication) | L2_2 Other subject information material poster | 2.0 |
| Subject information and informed consent form (for publication) | L2_2 Other subject information material poster_tc | 2.0 |
| Subject information and informed consent form (for publication) | patient brochure | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-29 | Belgium | Acceptable 2024-07-15
|
2024-07-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-20 | Belgium | Acceptable | 2025-02-26 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-03-02 | Acceptable | 2026-03-02 |