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

Part of paid clinical trials in Dallas, Texas.

Sponsor
Merz Pharmaceuticals GmbH
Study ID
NCT00407030
Phase
PHASE3
Status
Completed

Conditions

  • Cervical Dystonia

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Jul 31, 2006
Status verified
Jul 2013
Primary completion
Jan 31, 2008
Completion
Jun 30, 2009

Study Design

Enrollment
233 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: incobotulinumtoxinA (Xeomin) (240 Units)
    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
  • Experimental: incobotulinumtoxinA (Xeomin) (120 Units)
    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
  • Placebo Comparator: Placebo
    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

Primary Outcome Measure

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 [ Time Frame: Baseline, week 4 ]

Locations (1)

FacilityCityStateZIPSite coordinators
-DallasTexas--

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