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Clinical trial to see the effect and safety of botulinum toxin type A with doses adapted to patients with severe spasticity
EU CTIS ID: 2024-517668-51-01
What this study is testing
To determine the efficacy and safety of the administration of IncobotulinumtoxinA at individualized doses, selected based on the individual needs of patients (spasticity patterns) with severe spasticity and involvement of the upper and lower limbs.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients older than 18 years
- with a diagnosis of severe multifocal spasticity of the upper and lower limbs due to acquired brain damage
- Who need treatment with IncobotulinumtoxinA at a dose equal to or greater than 800U
- That they agree to participate in the study and sign the informed consent
- With pain assessment data (VAS scale), muscle tone (Asworth scale), and Barthel scale during the follow-up evaluation.
- No contraindications for treatment with botulinum toxin
You likely can't join if
- Patients with severe systemic diseases and active infection
- Pregnant patients or under lactating period.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.