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

NCT01910363 ↗

Phase 2/3 Unknown 30 enrolled University of Tokushima Ministry of Health, Labour and Welfare, Japan · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start: 2013-07
Primary completion: 2014-01
Completion: —

Publications

Kaji R. Clinical differences between A1 and A2 botulinum toxin subtypes. Toxicon. 2015 Dec 1;107(Pt A):85-8. doi: 10.1016/j.toxicon.2015.09.025. Epub 2015 Sep 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	A2NTX	Protein / enzyme biologic	300 iu	Intramuscular
Comparator	BOTOX®:onabotulinumtoxinA (Allergan Co Ltd), commercially available botulinum toxin type A1	Protein / enzyme biologic	300 iu	Intramuscular

Indications

No indication recorded.