Dose-response Study of Efficacy and Safety of Botulinum Toxin Type A to Treat Spasticity of the Leg(s) in Cerebral Palsy

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Merz Pharmaceuticals

Status and phase

Completed
Phase 3

Conditions

Lower Limb Spasticity Due to Cerebral Palsy

Treatments

Drug: IncobotulinumtoxinA (4 Units per kg body weight)
Drug: IncobotulinumtoxinA (16 Units per kg body weight)
Drug: IncobotulinumtoxinA (12 Units per kg body weight)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01893411
MRZ60201_3070_1
2012-005054-30 (EudraCT Number)

Details and patient eligibility

About

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 tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy.

Enrollment

311 patients

Sex

All

Ages

2 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

311 participants in 3 patient groups

16 Units per kg body weight incobotulinumtoxinA (Xeomin)
Experimental group
Treatment:
Drug: IncobotulinumtoxinA (16 Units per kg body weight)
12 Units per kg body weight incobotulinumtoxinA (Xeomin)
Experimental group
Treatment:
Drug: IncobotulinumtoxinA (12 Units per kg body weight)
4 Units per kg body weight incobotulinumtoxinA (Xeomin)
Experimental group
Treatment:
Drug: IncobotulinumtoxinA (4 Units per kg body weight)

Trial contacts and locations

53

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Data sourced from clinicaltrials.gov

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