Status:
COMPLETED
Dose-response Study of Efficacy and Safety of Botulinum Toxin Type A to Treat Spasticity of the Leg(s) in Cerebral Palsy
Lead Sponsor:
Merz Pharmaceuticals GmbH
Conditions:
Lower Limb Spasticity Due to Cerebral Palsy
Eligibility:
All Genders
2-17 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg(s) are effective in treating children/adolescents (age 2-17 years) with increased muscle ...
Eligibility Criteria
Inclusion
- Female or male subject of 2 to 17 years of age (inclusive).
- Uni- or bilateral cerebral palsy with clinical need for uni- or bilateral LL injections with BoNT for the treatment of spasticity.
- Ashworth Scale \[AS\] score ≥2 in plantar flexors (at least unilaterally).
- Clinical need for a total dose of 16 U/kg BW NT 201 (maximum of 400 U) for the treatment of LL spasticity according to the clinical judgment of the investigator.
Exclusion
- Fixed contracture defined as severe restriction of the range of joint movement on passive stretch or predominant forms of muscle hypertonia other than spasticity (e.g., dystonia) in the target limb(s).
- Surgery on pes equinus on side(s) intended to be treated with BoNT injections in this study within 12 months prior to Screening Visit (V1), in the screening period or planned for the time of participation in this study.
- Hip flexion requiring BoNT injection.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
311 Patients enrolled
Trial Details
Trial ID
NCT01893411
Start Date
June 1 2013
End Date
May 1 2016
Last Update
August 5 2021
Active Locations (53)
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1
Merz Investigational Site #043037
Graz, Austria, 8036
2
Merz Investigational Site #043036
Vienna, Austria, 1100
3
Merz Investigational Site #420029
Brno, Czechia, 65691
4
Merz Investigational Site #420028
Olomouc, Czechia, 77520