IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Cervical Dystonia

NCT00407030 | Completed Phase 3 Results DMC

• 1 other identifier: MRZ 60201-0408
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 1

Brief Summary

At baseline patients received incobotulinumtoxinA (Xeomin) or placebo. Thereafter, all patients who entered the extension period were treated with up to five injection sessions of incobotulinumtoxinA (Xeomin) during the extension period.

Conditions

Cervical Dystonia

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Placebo

  The TWSTRS-Total score is the sum of scores of the three components of the scale: * TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity) * TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain) * TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability). The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.

  Baseline, week 4

• Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (120 Units) Versus Placebo

  The TWSTRS-Total score is the sum of scores of the three components of the scale: * TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity) * TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain) * TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability). The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.

  Baseline, week 4

• Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Xeomin (120 Units)

  The TWSTRS-Total score is the sum of scores of the three components of the scale: * TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity) * TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain) * TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability). The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.

  Baseline, week 4

Secondary Outcomes (5)

• Change From Baseline in the TWSTRS-Total Score

  Baseline, week 8, final visit (up to 20 weeks after injection of the Main Period)

• Change From Baseline in the TWSTRS Disability Subscore

  Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)

• Change From Baseline in the TWSTRS Severity Subscore

  Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)

• Change From Baseline in the TWSTRS Pain Subscore

  Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)

• Patient Evaluation of Global Response (PEGR) at Final Visit

  Final visit (up to 20 weeks after injection of the Main Period)

Study Arms (3)

incobotulinumtoxinA (Xeomin) (240 Units)

EXPERIMENTAL

incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 240 units, total volume 4.8mL; Mode of administration: intramuscular injection

Drug: incobotulinumtoxinA (Xeomin) (240 Units)

incobotulinumtoxinA (Xeomin) (120 Units)

EXPERIMENTAL

incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 120 units, total volume 4.8 mL; Mode of administration: intramuscular injection

Drug: incobotulinumtoxinA (Xeomin) (120 Units)

Placebo

PLACEBO COMPARATOR

Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 4.8 mL; Mode of administration: intramuscular injection

Drug: Placebo

Interventions

incobotulinumtoxinA (Xeomin) (240 Units) DRUG

incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (240 Units)

incobotulinumtoxinA (Xeomin) (240 Units)

incobotulinumtoxinA (Xeomin) (120 Units) DRUG

incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (120 Units)

incobotulinumtoxinA (Xeomin) (120 Units)

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female outpatients between ages 18 and 75 years inclusive)
• A clinical diagnosis of cervical dystonia (i.e. spasmodic torticollis) with predominantly rotational form and a need for injection (determined by the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total score)
• TWSTRS-Total score \>= 20
• TWSTRS-Severity score \>= 10
• TWSTRS-Disability score \>= 3
• TWSTRS-Pain score \>= 1
• On a stable dose of medications (if any) used for focal dystonia treatment (e.g. anticholinergics and benzodiazepines) for at least 3 months prior to and expected throughout the Main Period
• For pre-treated patients only: Source documentation of the last two consecutive injection sessions with Botulinum Toxin and stable therapeutic response directly prior to trial entry
• For pre-treated patients only: At least 10 weeks must have been passed between the last injection with Botulinum Toxin for cervical dystonia and baseline
• For pre-treated patients only: The most recent injection with Botulinum Toxin must have been maximal 300 Units of type A or 12,000 Units of type B

You may not qualify if:

• Traumatic torticollis or tardive torticollis
• TWSTRS-Severity score for anterocollis \>= 2 points (pure anterocollis)
• TWSTRS-Severity score for retrocollis \>= 2 points (pure retrocollis)
• Myotomy or denervation surgery in the affected muscles (e.g. peripheral denervation and/or spinal cord stimulation)
• Hypersensitivity to human serum albumin, sucrose, or Botulinum Toxin Type A
• Diagnosis of myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease which might interfere with the trial
• Current swallowing disorder of any origin (dysphagia scale \>= 3, i.e. severe, with swallowing difficulties and requiring a change in diet)
• Marked limitation on passive range of motion that suggests contractures or other structural abnormality, e.g. cervical contractures or cervical spine syndrome
• Treatment with Botulinum Toxins for any indication other than cervical dystonia within 4 months prior to baseline and during the trial

Sponsors & Collaborators

• Merz Pharmaceuticals GmbH: lead

Study Sites (1)

Unknown Facility

Dallas, Texas, United States

Location

Related Publications (2)

• Comella CL, Jankovic J, Truong DD, Hanschmann A, Grafe S; U.S. XEOMIN Cervical Dystonia Study Group. Efficacy and safety of incobotulinumtoxinA (NT 201, XEOMIN(R), botulinum neurotoxin type A, without accessory proteins) in patients with cervical dystonia. J Neurol Sci. 2011 Sep 15;308(1-2):103-9. doi: 10.1016/j.jns.2011.05.041. Epub 2011 Jul 18.

  PMID: 21764407 RESULT

• Evidente VG, Fernandez HH, LeDoux MS, Brashear A, Grafe S, Hanschmann A, Comella CL. A randomized, double-blind study of repeated incobotulinumtoxinA (Xeomin((R))) in cervical dystonia. J Neural Transm (Vienna). 2013 Dec;120(12):1699-707. doi: 10.1007/s00702-013-1048-3. Epub 2013 Jun 19.

  PMID: 23779062 RESULT

MeSH Terms

Conditions

Torticollis

Interventions

incobotulinumtoxinA

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Angelika Hanschmann
• Organization: Merz Pharmaceuticals GmbH

angelika.hanschmann@merz.de

++49-69-1503

Study Officials

• Cynthia Comella, M.D.

  Rush University Medical Center, 1725 West Harrison Street, Suite 755, Chicago, 60612 Illinois, USA

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2006
• First Posted: December 4, 2006
• Study Start: July 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: June 1, 2009
• Last Updated: July 19, 2013
• Results First Posted: December 31, 2010

Record last verified: 2013-07

Locations

US (1)