Open-Label Non-Inferiority Study Evaluating the Efficacy and Safety of Xeomin® in Subjects With Cervical Dystonia Flex

NCT01486264 | Completed Phase 4 Results

• 1 other identifier: MUS60201_4073_1
• Study Type: interventional
• Target: 283
• Locations: 1 country
• Sites: 43

Brief Summary

This study will compare Xeomin®, a botulinum toxin medication, in shorter treatment intervals (Short Flex dosing) to the standard interval dosing (Long Flex dosing) to determine if the response to treatment is comparable in both how it works and any side effects. Xeomin® is approved by the United States Food and Drug Administration (FDA) for the treatment of cervical dystonia (CD). The use of Xeomin® is investigational in regards to shorter treatment intervals. An investigational use is one that is not approved by the FDA.

Conditions

Cervical Dystonia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Severity Subscale Score Based on Blinded Rater Assessment at Week 4 After the 8th Injection

  The validated assessment scale TWSTRS was used to measure the impact of cervical dystonia (CD) on participants. A blinded rater performed all TWSTRS-Severity subscale assessments for a given participant. TWSTRS-Severity subscale score ranges from 0 (=absence of severity) to 35 points (=maximum severity).

  Baseline and Week 4 after the 8th injection (Week 44 to 68 for Short Flex and Week 84 to 104 for Long Flex)

Secondary Outcomes (12)

• Change From Baseline in TWSTRS Total Score Based on Blinded Rater Assessment at Week 4 After the 8th Injection

  Baseline and Week 4 after the 8th injection (Week 44 to 68 for Short Flex and Week 84 to 104 for Long Flex)

• Change From Baseline in TWSTRS Total Score Based on Unblinded Rater Assessment at Week 4 After the 8th Injection

  Baseline and Week 4 after the 8th injection (Week 44 to 68 for Short Flex and Week 84 to 104 for Long Flex)

• Change From Baseline in TWSTRS Severity Subscale Based on Unblinded Rater Assessment at Week 4 After the 8th Injection

  Baseline and Week 4 after the 8th injection (Week 44 to 68 for Short Flex and Week 84 to 104 for Long Flex)

• Change From Baseline in TWSTRS Disability Subscale Based on Unblinded Rater Assessment at Week 4 After the 8th Injection

  Baseline and Week 4 after the 8th injection (Week 44 to 68 for Short Flex and Week 84 to 104 for Long Flex)

• Change From Baseline in TWSTRS Pain Subscale Based on Unblinded Rater Assessment at Week 4 After the 8th Injection

  Baseline and Week 4 after the 8th injection (Week 44 to 68 for Short Flex and Week 84 to 104 for Long Flex)

Study Arms (2)

Xeomin® Short Flex

ACTIVE COMPARATOR

short flex dosing of Xeomin. It is a botulinum toxin type A produced from fermentation of Hall strain Clostridium botulinum serotype A.

Biological: Xeomin®

Xeomin® Long Flex

ACTIVE COMPARATOR

long flex dosing of Xeomin. It is a botulinum toxin type A produced from fermentation of Hall strain Clostridium botulinum serotype A.

Biological: Xeomin®

Interventions

Xeomin® BIOLOGICAL

Xeomin is botulinum toxin type A produced from fermentation of Hall strain Clostridium botulinum serotype A

Also known as: botulinum toxin, botulinum toxin type A

Xeomin® Long Flex; Xeomin® Short Flex

Eligibility Criteria

• Age: 18 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented clinical diagnosis of idiopathic or genetic Cervical Dystonia

You may not qualify if:

• Current treatment with botulinum toxin of any type for any other indication (including aesthetic indications) and for any body region during the study.

Sponsors & Collaborators

• Merz Pharmaceuticals GmbH: lead
• Merz North America, Inc.: collaborator

Study Sites (43)

Merz Investigative Site #001234

Birmingham, Alabama, 35294-0017, United States

Location

Merz Investigative Site 001017

Fountain Valley, California, 92708, United States

Location

Merz Investigative Site #001225

Loma Linda, California, 92354-3450, United States

Location

Merz Investigative Site #001219

Los Angeles, California, 90033, United States

Location

Merz Investigative Site # 001276

Manchester, Connecticut, 06040, United States

Location

Merz Investigative Site #001231

Washington D.C., District of Columbia, 20007, United States

Location

Merz Investigative Site #001076

Boca Raton, Florida, 33486, United States

Location

Merz Investigative Site #001019

Gainesville, Florida, 32610, United States

Location

Merz Investigative Site #001046

Jacksonville, Florida, 32209, United States

Location

Merz Investigative Site #001075

Melbourne, Florida, 32901, United States

Location

Merz Investigative Site #001217

Port Charlotte, Florida, 33980, United States

Location

Merz Investigative Site #1253

Tampa, Florida, 33613, United States

Location

Merz Investigative Site #001055

Atlanta, Georgia, 30329, United States

Location

Merz Investigative Site# 01255

Chicago, Illinois, 60611, United States

Location

Merz Investigative Site #001215

Chicago, Illinois, 60612, United States

Location

Merz Investigative Site # 01069

Des Moines, Iowa, 50309, United States

Location

Merz Investigative Site #001110

Overland Park, Kansas, 66211, United States

Location

Merz Investigative Site # 001071

Elkridge, Maryland, 21075, United States

Location

Merz Investigative Site # 001018

Detroit, Michigan, 48201-2153, United States

Location

Merz Investigative Site #001030

Farmington Hills, Michigan, 48334, United States

Location

Merz Investigative Site # 0001275

Eagan, Minnesota, 55121, United States

Location

Merz Investigative Site #1250

St Louis, Missouri, 63104, United States

Location

Merz Investigative Site #001210

St Louis, Missouri, 63110, United States

Location

Merz Investigative Site #001221

Albany, New York, 12208, United States

Location

Merz Investigative Site #001233

New York, New York, 10003, United States

Location

Merz Investigative Site #1256

New York, New York, 10029-6574, United States

Location

Merz Investigative Site# 01252

Charlotte, North Carolina, 28207, United States

Location

Merz Investigative Site #001005

Durham, North Carolina, 27705, United States

Location

Merz Investigative Site# 01260

Raleigh, North Carolina, 27607, United States

Location

Merz Investigative Site #001009

Winston-Salem, North Carolina, 27157, United States

Location

Merz Investigative Site #1265

Cincinnati, Ohio, 45219, United States

Location

Merz Investigative Site #001220

Tulsa, Oklahoma, 74136, United States

Location

Merz Investigative Site #1033

Portland, Oregon, 97239, United States

Location

Merz Investigative Site #1251

Portland, Oregon, 97239, United States

Location

Merz Investigative Site # 0001271

Hershey, Pennsylvania, 17033, United States

Location

Merz Investigative Site #1249

Philadelphia, Pennsylvania, 19107, United States

Location

Merz Investigative Site #001206

Nashville, Tennessee, 37232-2551, United States

Location

Merz Investigative Site #1074

Dallas, Texas, 75214, United States

Location

Merz Investigative Site #001223

Dallas, Texas, 75231, United States

Location

Merz Investigative Site # 001216

Houston, Texas, 77030, United States

Location

Merz Investigative Site# 001266

Houston, Texas, 77030, United States

Location

Merz Investigative Site #001224

Kirkland, Washington, 98034, United States

Location

Merz Investigative Site #1270

Seattle, Washington, 98122, United States

Location

Related Publications (1)

• Comella C, Hauser RA, Isaacson SH, Truong D, Oguh O, Hui J, Molho ES, Brodsky M, Furr-Stimming E, Comes G, Hast MA, Charles D. Efficacy and safety of two incobotulinumtoxinA injection intervals in cervical dystonia patients with inadequate benefit from standard injection intervals of botulinum toxin: Phase 4, open-label, randomized, noninferiority study. Clin Park Relat Disord. 2022 Mar 14;6:100142. doi: 10.1016/j.prdoa.2022.100142. eCollection 2022.

  PMID: 35330880 RESULT

MeSH Terms

Conditions

Torticollis

Interventions

incobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Public Disclosure Manager
• Organization: Merz Pharmaceuticals GmbH

clinicaltrials@merz.com

+49 69 1503 1

Study Officials

• Michael Kulagowski, MD

  Merz North America, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2011
• First Posted: December 6, 2011
• Study Start: January 20, 2012
• Primary Completion: March 29, 2016
• Study Completion: March 29, 2016
• Last Updated: October 27, 2022
• Results First Posted: September 6, 2019

Record last verified: 2017-04

Locations

US (43)