NCT03617367 (ASPEN-OLS) is a Phase 3 clinical trial of daxibotulinumtoxinA for injection in Cervical Dystonia, sponsored by Revance Therapeutics, Inc..

Who is sponsoring NCT03617367?

NCT03617367 is sponsored by Revance Therapeutics, Inc..

What drugs are being tested in NCT03617367?

Interventions in NCT03617367: daxibotulinumtoxinA for injection.

What condition does NCT03617367 study?

NCT03617367 studies Cervical Dystonia.

Is NCT03617367 still recruiting?

NCT03617367 is currently completed. Last updated 28 January 2022.

Last reviewed 2022-01-28 · How we verify

NCT03617367: ASPEN-OLS

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

Long-Term Safety and Efficacy of Repeat Treatments of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-OLS)

Completed Phase 3 Last updated 28 January 2022

What this trial tests

Phase 3 trial testing daxibotulinumtoxinA for injection in Cervical Dystonia in 357 participants. Completed in 25 May 2021.

Timeline

5 September 2018

Primary endpoint
25 May 2021

25 May 2021

Quick facts

Lead sponsor	Revance Therapeutics, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	357
Start date	5 September 2018
Primary completion	25 May 2021
Estimated completion	25 May 2021
Sites	65 locations across France, Austria, United Kingdom, Germany, Poland, Canada, United States, Spain

Drugs / interventions tested

daxibotulinumtoxinA for injection — full drug profile →

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

Phase 3, open-label, multi-center trial to evaluate the long-term safety, efficacy, and immunogenicity of up to four continuous treatment cycles of daxibotulinumtoxinA (DAXI) for injection.

Publications & conference data

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

Treatment of Dystonia: Medications, Neurotoxins, Neuromodulation, and Rehabilitation.
Bledsoe IO, Viser AC, San Luciano M. · · 2020 · cited 34× · PMID 33095402 · DOI 10.1007/s13311-020-00944-0
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
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
Long-Term Safety and Efficacy of Repeat Treatments with DaxibotulinumtoxinA in Cervical Dystonia: Results from the ASPEN-Open-Label Study.
McAllister P, Patel AT, Banach M, Ellenbogen A, et al · · 2025 · cited 1× · PMID 40439027 · DOI 10.1002/mdc3.70104
Efficacy Remaining at Time of Requested Re-Treatment for Cervical Dystonia: A Potential New Treatment Paradigm with DaxibotulinumtoxinA.
Ellenbogen A, Hauser RA, Patel AT, McAllister P, et al · · 2025 · PMID 40137906 · DOI 10.3390/toxins17030133

Verify or expand the search:

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 NCT03617367 (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: 28 January 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/NCT03617367.

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