Who is sponsoring NCT03608397?

NCT03608397 is sponsored by Revance Therapeutics, Inc..

What drugs are being tested in NCT03608397?

Interventions in NCT03608397: DaxibotulinumtoxinA for injection, Placebo.

What condition does NCT03608397 study?

NCT03608397 studies Cervical Dystonia.

Is NCT03608397 still recruiting?

NCT03608397 is currently completed. Last updated 5 December 2022.

Last reviewed 2022-12-05 · How we verify

NCT03608397: ASPEN-1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Last updated 5 December 2022

What this trial tests

Phase 3 trial testing DaxibotulinumtoxinA for injection in Cervical Dystonia in 301 participants. Completed in 16 June 2020.

Timeline

20 June 2018

Primary endpoint
3 December 2019

16 June 2020

Quick facts

Lead sponsor	Revance Therapeutics, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	301
Start date	20 June 2018
Primary completion	3 December 2019
Estimated completion	16 June 2020
Sites	75 locations across France, Austria, United Kingdom, Germany, Poland, Canada, United States, Spain

Drugs / interventions tested

DaxibotulinumtoxinA for injection — full drug profile →
Placebo

Conditions studied

Cervical Dystonia — all drugs for Cervical Dystonia →

Sponsor

Revance Therapeutics, Inc. — full company profile →

Who can join

Adults 18 to 80, any sex, with Cervical Dystonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Medical and Surgical Treatments for Dystonia.
Jinnah HA. · · 2020 · cited 33× · PMID 32279713 · DOI 10.1016/j.ncl.2020.01.003
Cell-Penetrating Peptide-Based Delivery of Macromolecular Drugs: Development, Strategies, and Progress.
Sun Z, Huang J, Fishelson Z, Wang C, et al · · 2023 · cited 31× · PMID 37509610 · DOI 10.3390/biomedicines11071971
Efficacy and Safety of DaxibotulinumtoxinA for Injection in Cervical Dystonia: ASPEN-1 Phase 3 Randomized Controlled Trial.
Comella CL, Jankovic J, Hauser RA, Patel AT, et al · · 2024 · cited 19× · PMID 38295339 · DOI 10.1212/wnl.0000000000208091
Exploring the Chemical Features and Biomedical Relevance of Cell-Penetrating Peptides.
Moreno-Vargas LM, Prada-Gracia D. · · 2024 · cited 14× · PMID 39795918 · DOI 10.3390/ijms26010059
OnabotulinumtoxinA Dosing, Disease Severity, and Treatment Benefit in Patients With Cervical Dystonia: A Cohort Analysis From CD PROBE.
Agarwal P, Barbano R, Moore H, Schwartz M, et al · · 2022 · cited 7× · PMID 35847221 · DOI 10.3389/fneur.2022.914486
Treatment of dystonia and tics.
Bellows S, Jankovic J. · · 2020 · cited 6× · PMID 34316614 · DOI 10.1016/j.prdoa.2019.11.005

Verify or expand the search:

Other trials of DaxibotulinumtoxinA for injection

Trials testing the same drug.

NCT04259086 — Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Upper Facial Lines · Phase 2 · completed
NCT03911102 — Efficacy and Safety of Increasing Doses of DaxibotulinumtoxinA for Injection (DAXI for Injection) in the Treatment of Mo · Phase 2 · completed
NCT03786770 — Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Forehead Lines (Frontalis) · Phase 2 · completed

Other recruiting trials for Cervical Dystonia

Currently open trials in the same condition.

NCT07140874 — Zinc as an Adjunctive Therapy for Cervical Dystonia · Phase 2 · recruiting
NCT06937931 — A Study of IPN10200 for the Treatment of Cervical Dystonia in Adults · Phase 2 · recruiting

Other Revance Therapeutics, Inc. trials

Trials by the same sponsor.

NCT06411002 — Phase 2a Study of DaxibotulinumtoxinA-lanm for Injection in Dynamic Forehead Lines and Glabellar Lines · Phase 2 · completed
NCT04846530 — Teosyal RHA® Histology and Intradermal Implantation Evaluation Study · unknown
NCT04259086 — Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Upper Facial Lines · Phase 2 · completed
NCT03911102 — Efficacy and Safety of Increasing Doses of DaxibotulinumtoxinA for Injection (DAXI for Injection) in the Treatment of Mo · Phase 2 · completed
NCT03786770 — Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Forehead Lines (Frontalis) · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03608397 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Revance Therapeutics, Inc.
Last refreshed: 5 December 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03608397.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing