Study of a New Generation Botulinum Toxin A2NTX to Treat Spasticity After Stroke "A2NTX"

Active, not recruiting

Phase 2/3 Results N/A

Trial Description

To test the safety and efficacy of a new generation botulinum toxin preparation A2NTX for treating stroke patients with lower limb spasticity.
- we study the degree of spasticity in the ankle and knee joints, and walking speed in 30 patients with stroke before and after injecting 300 units of BOTOX or A2NTX in a blinded manner as for the patient, the physician, and the examiner.
- we also assess the safety of A2NTX and compare it to that of BOTOX.

Conditions

Interventions

  • Botox Drug
    Intervention Desc: Intramuscular injection of the botulinum toxin preparation in 300 units (mouse LD50) into tibialis posterior and medial gastrocnemius muscles on the affected side.
    ARM 1: Kind: Experimental
    Label: BOTOX
    Description: single intramuscular injection of 300 units of BOTOX®, a commercially available botulinum toxin preparation of type A1
  • A2NTX Drug
    Other Names: A2NTX:low molecular weight (150kDalton) purified botulinum toxin type A2 preparation
    Intervention Desc: Intramuscular injection of the botulinum toxin preparation in 300 units (mouse LD50) into tibialis posterior and medial gastrocnemius muscles on the affected side.
    ARM 1: Kind: Experimental
    Label: A2NTX
    Description: single intramuscular injection of 300 units of A2NTX, a purified low molecular weight (150 kDalton) botulinum toxin preparation of type A2

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in Modified Ashworth Scale of the ankle joint 30-60 days after injection No
Secondary Change in Functional Independence Measure (FIM) 30 days after injection No

Sponsors