Dose-response Study of Efficacy and Safety of Botulinum Toxin Type A to Treat Spasticity of the Arm(s) or of Arm(s) and Leg(s) in Cerebral Palsy
Public ClinicalTrials.gov record NCT02002884. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Prospective, Multicenter, Randomized, Double-blind, Parallel-group, Dose-response Study of Three Doses Xeomin® (incobotulinumtoxinA, NT 201) for the Treatment of Upper Limb Spasticity Alone or Combined Upper and Lower Limb Spasticity in Children and Adolescents (Age 2 - 17 Years) With Cerebral Palsy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of one or both arms alone or in combination with injections into one or both legs are effective and safe in treating children/adolescents (age 2-17 years) with increased muscle tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy.
Study identification
- NCT ID
- NCT02002884
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 351 participants
Conditions and interventions
Conditions
Interventions
- IncobotulinumtoxinA (8 Units per kg body weight) Drug
- IncobotulinumtoxinA (6 Units per kg body weight) Drug
- IncobotulinumtoxinA (2 Units per kg body weight) Drug
Drug
Eligibility (public fields only)
- Age range
- 2 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 28, 2014 (Actual)
- Primary completion
- Jul 4, 2017 (Actual)
- Completion
- Aug 28, 2018 (Actual)
- Last update posted
- Aug 5, 2021
2014 – 2018
United States locations
- U.S. sites
- 6
- U.S. states
- 5
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Merz Investigational Site #001286 | Gulf Breeze | Florida | 32561 | — |
| Merz Investigational Site #001284 | Loxahatchee Groves | Florida | 33470 | — |
| Merz Investigational Site #001285 | Savannah | Georgia | 31405 | — |
| Merz Investigational Site #001186 | Chicago | Illinois | 60611 | — |
| Merz Investigational Site No. #001302 | Royal Oak | Michigan | 48073 | — |
| Merz Investigational Site #001283 | Columbia | Missouri | 65212 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 26 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02002884, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 5, 2021 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02002884 live on ClinicalTrials.gov.