BridgeMD
A clinical study to investigate the efficacy and safety of NT 201 in the treatment of lower limb spasticity in children and adolescents with cerebral palsy.
EU CTIS ID: 2023-503420-19-00
What this study is testing
To demonstrate efficacy by showing superiority of NT 201 compared intra-individually to placebo in children and adolescents with LL SP caused by CP at week 4 to week 6 after a single injection.
- Therapeutic confirmatory (Phase III)
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
- Male and female subjects ≥ 2 to ≤ 17 years of age
- Bilateral, symmetrical pes equinus due to LL SP caused by CP in subjects with any Gross Motor Function Classification System (GMFCS) level
- Identical MAS plantar flexor score of ≥ 2 for pes equinus clinical patterns in both legs at neutral ankle position and knee at maximum extension
- Main eligibility criteria for Open-Label Extension Period (OLEX): MAS plantar flexor score of ≥ 1 in both pes equinus clinical patterns
- Main eligibility criteria for Open-Label Extension Period (OLEX): Agreement of investigator, parent(s), and subject (if applicable) to continue treatment
You likely can't join if
- Pre-dominant forms of muscle hypertonia/hyperactivity other than LL SP (e.g., rigidity, dystonia, dyskinesia)
- Previous treatment with Botulinum neurotoxin (BoNT) of any serotype in any body region within the last four months before injection at baseline visit
- Fixed contracture in at least one of both pes equinus
- Significant involuntary movements or limitations that hinder MAS assessment or positioning
- Clinically significant SP in LL clinical patterns other than pes equinus; or gait patterns drop foot, crouch gait, and equinus with jump knee
- Limitation of hip abduction to less than 40° or pre-diagnosed migrational percentage greater than 30°
The study team makes the final eligibility decision.
Where it's taking place
- Turkey
- Ukraine
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, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turkey; Ukraine. Enter your location above to see the nearest site and check your eligibility.
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.