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
Completed · Phase 3
Conditions studied: Cerebral Palsy, Spasticity
In brief
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.
Key facts
- Study ID
- NCT02002884
- Run by
- Merz Pharmaceuticals GmbH
- People needed
- 351
- Starts
- 2014-03-28
- Expected to finish
- 2018-08-28
- Last updated by the study team
- 2021-08-05
Who can join
Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Female or male subject of 2 to 17 years of age (inclusive).
- Uni- or bilateral Cerebral Palsy (CP) with clinical need for injections with NT 201 for the treatment of upper limb (UL) spasticity at least unilaterally.
- Ashworth Scale (AS) score in the main clinical target patterns in this study:
- Flexed elbow: AS≥2 in elbow flexors (at least unilaterally). and/or
- Flexed Wrist: AS≥2 in wrist flexors (at least unilaterally).
- Clinical need according to the judgment of the investigator in one out of five treatment combinations (A-E, as shown below). AS score must be ≥2 for each target pattern chosen for injection at the Baseline Injection Visit V2.
- A. UL(s) treatment only (GMFCS I-V):
- A1) Unilateral treatment of UL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) for:
- At least one of the main clinical target patterns flexed elbow (4 U/kg BW) and/or flexed wrist (2 U/kg BW).
- and
- Additional clinical patterns in the same limb (i.e., clenched fist, thumb in palm, and/or pronated forearm) with the remaining units until maximum dose of 8 U/kg BW (maximum of 200 U) for treatment of a single UL is reached.
- or
- A2) Bilateral treatment of UL spasticity with equal doses of 8 U/kg BW NT 201 (maximum of 200 U) to each UL. Dose per UL must be distributed between:
- At least one of the main clinical target patterns flexed elbow (4 U/kg BW) and/or flexed wrist (2 U/kg BW).
- and
- Additional clinical patterns in the same limb (i.e., clenched fist, thumb in palm, and/or pronated forearm) with the remaining units until maximum dose of 8 U/kg BW (maximum of 200 U) for treatment of a single UL is reached.
- B. Unilateral UL and unilateral lower limb (LL) treatment (GMFCS I-V):
- B1) Unilateral treatment of UL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) for:
- At least one of the main clinical target patterns flexed elbow (4 U/kg BW) and/or flexed wrist (2 U/kg BW).
- and
- Additional clinical patterns in the same limb (i.e., clenched fist, thumb in palm, and/or pronated forearm) with the remaining units until maximum dose of 8 U/kg BW (maximum of 200 U) for treatment of a single UL is reached.
- plus
- B2) Ipsilateral unilateral treatment of LL spasticity with 8 U/kg BW NT 201 (maximum of 200 U). Dose to LL must be distributed to at least one of clinical target patterns pes equinus, flexed knee, adducted thigh, and extended great toe as clinically needed.
- C. Unilateral UL and bilateral LL treatment (GMFCS I-III)
- C1) Unilateral treatment of UL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) for:
You may not qualify if…
- Pre-treated (non-naïve) subjects must not have received BoNT treatment within the last 14 weeks prior to Screening Visit (V1) in any indication.
Where it is running
- Merz Investigational Site #001286 — Gulf Breeze, Florida, United States
- Merz Investigational Site #001284 — Loxahatchee Groves, Florida, United States
- Merz Investigational Site #001285 — Savannah, Georgia, United States
- Merz Investigational Site #001186 — Chicago, Illinois, United States
- Merz Investigational Site No. #001302 — Royal Oak, Michigan, United States
- Merz Investigational Site #001283 — Columbia, Missouri, United States
- Merz Investigational Site #054010 — Godoy Cruz, Mendoza Province, Argentina
- Merz Investigational Site #054005 — Caba, Argentina
- Merz Investigational Site #052023 — Aguascalientes, Mexico
- Merz Investigational Site #052003 — Guadalajara, Mexico
- Merz Investigational Site #052024 — Mexico City, Mexico
- Merz Investigational Site #052022 — Mexico City, Mexico
- Merz Investigational Site #052027 — Monterrey, Mexico
- Merz Investigational Site #052028 — Monterrey, Mexico
- Merz Investigational Site #052026 — Zapopan, Mexico
- Merz Investigational Site #048089 — Bialystok, Poland
- Merz Investigational Site #048063 — Gdansk, Poland
- Merz Investigational Site #048059 — Krakow, Poland
- Merz Investigational Site #048084 — Lublin, Poland
- Merz Investigational Site #048094 — Poznan, Poland
- Merz Investigational Site #048075 — Sandomierz, Poland
- Merz Investigational Site #048060 — Wiązowna, Poland
- Merz Investigational Site #007014 — Kazan', Russia
- Merz Investigational Site #007015 — Khabarovsk, Russia
- Merz Investigational Site #007018 — Novosibirsk, Russia
Full record on ClinicalTrials.gov
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