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

Completed · Phase 3 · Has a placebo group

Conditions studied: Cervical Dystonia

In brief

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).

Key facts

Study ID

NCT03608397

Run by

Revance Therapeutics, Inc.

People needed

301

Starts

2018-06-20

Expected to finish

2020-06-16

Last updated by the study team

2022-12-05

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults, 18 to 80 years of age
• Meets diagnostic criteria for isolated CD (idiopathic; dystonic symptoms localized to the head, neck, shoulder areas) with at least moderate severity at Baseline (Day 1), defined as a TWSTRS-total score of at least 20, with at least 15 on the TWSTRS-Severity subscale, at least 3 on the TWSTRS-Disability subscale, and at least 1 on the TWSTRS-Pain subscale

You may not qualify if…

• Cervical dystonia attributable to an underlying etiology, (e.g., traumatic torticollis or tardive torticollis)
• Predominant retrocollis or anterocollis CD
• Significant dystonia in other body areas, or is currently being treated with BoNT for dystonia in areas other than those associated with isolated CD
• Severe dysphagia (Grade 3 or 4 on the Dysphagia Severity Scale) at Screening or Baseline (prior to study treatment)
• Any neuromuscular neurological conditions that may place the subject at increased risk of morbidity with exposure to BoNT, including peripheral motor neuropathic diseases (e.g., amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis)
• Previous treatment with any BoNT product for any condition within the 14 weeks prior to Screening
• Botulinum Neurotoxin Type A (BoNTA), except the investigational daxibotulinumtoxinA, treatment-experienced subjects who had suboptimal or no treatment response to the most recent BoNTA injection for CD, as determined by the investigator, or history of primary or secondary non-response to BoNTA injections, known to have neutralizing antibodies to BoNTA; or have a history of botulinum toxin type B (rimabotulinumtoxinB [Myobloc/Neurobloc]) injection for CD due to non-response or suboptimal response to BoNTA

Where it is running

• Movement Disorders Center of Arizona — Scottsdale, Arizona, United States
• The Parkinsons and Movement Disorder Institute — Fountain Valley, California, United States
• University of California, Irvine — Irvine, California, United States
• Loma Linda University — Loma Linda, California, United States
• USC Keck School of Medicine — Los Angeles, California, United States
• Care Access Research — Pasadena, California, United States
• Sutter Institute for Medical Research — Sacramento, California, United States
• Rocky Mountain Movement Disorders Center — Englewood, Colorado, United States
• Associated Neurologist, P.C. — Danbury, Connecticut, United States
• New England Institute for Clinical Research — Stamford, Connecticut, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Parkinson's Disease and Movement Disorders Center of Boca Raton — Boca Raton, Florida, United States
• Design Neuroscience Center — Doral, Florida, United States
• University of Florida Center for Movement Disorders and Neurorestoration — Gainesville, Florida, United States
• Infinity Clinical Research — Hollywood, Florida, United States
• University of Florida Health Science Center Jacksonville — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• Suncoast Neuroscience Associates — St. Petersburg, Florida, United States
• USF Parkinson's Disease and Movement Disorders Center — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Kansas Institute of Reseach — Overland Park, Kansas, United States
• Michigan State University — East Lansing, Michigan, United States
• QUEST Research Institute — Farmington, Michigan, United States
• HOPE Research Institute — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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