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NCT06296082: STROKEPOC

Comparative Study of the Effects of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity

Recruiting now Phase 2, PHASE3 Last updated 20 February 2025
What this trial tests

Phase 2, PHASE3 trial testing Botulinum toxin type A in Stroke in 90 participants. Currently enrolling.

Timeline
1 September 2024
Primary endpoint
30 December 2025
31 December 2025

Quick facts

Lead sponsorUniversiteit Antwerpen
PhasePhase 2, PHASE3
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment90
Start date1 September 2024
Primary completion30 December 2025
Estimated completion31 December 2025
Sites3 locations across Belgium, Canada, Spain

Drugs / interventions tested

Conditions studied

Sponsor

Universiteit Antwerpen — full company profile →

Who can join

Adults 18 to 75, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a randomized parallel group clinical trial which will be conducted in three countries (Spain, Canada and Belgium) comparing Botulinum Toxin type A (BTX-A) and Dry Needling (DN) effectiveness for post-stroke spasticity in participants who had a first stroke in the previous 12 months and have plantar flexor spasticity. Participants will be randomly allocated to receive either one session of BTX-A or 12 weekly sessions of DN. Blinded evaluators will assess the effects before, during, and after treatment, and at a 4-week follow-up.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Spinal mechanisms and feasibility of Dry Needling versus Botulinum Toxin Type A in post-stroke lower limb spasticity: A proof-of-concept randomized clinical trial protocol (STROKE-POC).
    Pujol-Fuentes C, Eeckhaut B, Fernández Carnero S, Fernández Sanchís D, et al · · 2026 · PMID 42160369 · DOI 10.1371/journal.pone.0334571

Verify or expand the search:

Other trials of Botulinum toxin type A

Trials testing the same drug.

Other recruiting trials for Stroke

Currently open trials in the same condition.

Other Universiteit Antwerpen trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06296082.

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