Single Treatment of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-1)

Phase 3 Completed 301 enrolled Revance Therapeutics, Inc. Syneos Health · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized, double-blind, placebo-controlled, parallel group, multi-center trial of two doses of daxibotulinumtoxinA (DAXI) for injection (high-dose; low-dose in adult subjects with isolated (primary) cervical dystonia (CD).

Timeline

Start: 2018-06-20
Primary completion: 2019-12-03
Completion: 2020-06-16

Outcome

Met primary endpoint

paper DAXI 125U and 250U significantly improved the mean TWSTRS total score vs placebo PMID 38295339 ↗

paper DAXI 125U, -8.5 [1.93], p < 0.0001; DAXI 250U, -6.6 [1.92], p = 0.0006). PMID 38295339 ↗

Publications

Comella CL, Jankovic J, Hauser RA, Patel AT, Banach MD, Ehler E, Vitarella D, Rubio RG, Gross TM; ASPEN-1 Study Group. Efficacy and Safety of DaxibotulinumtoxinA for Injection in Cervical Dystonia: ASPEN-1 Phase 3 Randomized Controlled Trial. Neurology. 2024 Feb 27;102(4):e208091. doi: 10.1212/WNL.0000000000208091. Epub 2024 Jan 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Botulinum toxin type A	Protein / enzyme biologic	125 iu	Intramuscular
Subject	Botulinum toxin type A	Protein / enzyme biologic	250 iu	Intramuscular