Daily Dystonia Practice - A Trial to Investigate NT 201, the Duration of Treatment Effect After One Injection Session and in Long-term Treatment in Cervical Dystonia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT00541905
First received: October 8, 2007
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

The aim of this study is to confirm efficacy and safety of NT 201 (Xeomin®, also known as IncobotulinumtoxinA) after one injection session and to determine the efficacy and safety profile and the duration of treatment effect of NT 201 in long-term treatment with repeated injection sessions.


Condition Intervention Phase
Cervical Dystonia
Drug: NT 201
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Single-arm, Multicenter Trial to Investigate the Efficacy and Safety of NT 201 and the Duration of Treatment Effect After One Injection Session and in Long-term Treatment in Patients With Cervical Dystonia

Resource links provided by NLM:


Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:
  • Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), total score: Change from study baseline (initial injection session) to week 4 [ Time Frame: From baseline to week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • TWSTRS, Single interventional effect [ Time Frame: From week 10-24 to week 14-28, from week 20-48 to week 24-52, from week 30-72 to week 34-76, and from week 40-96 to week 44-100 ] [ Designated as safety issue: No ]
    Single interventional effect of one injection session by the change of the TWSTRS total, severity and disability scores from each cycle baseline to 4 weeks thereafter.

  • TWSTRS, overall interventional effect [ Time Frame: From study baseline to week 14-28, 24-52, 34-76, and 44-100 ] [ Designated as safety issue: No ]
    Measured by the change in the TWSTRS total, severity and disability scores, from study baseline to each examination 4 weeks after the injection sessions

  • Global Assessment of Efficacy by Investigator (GAEI) [ Time Frame: Week 10-24, 20-48, 30-72, and 40-96 ] [ Designated as safety issue: No ]
    At the end of each injection cycle

  • Subject Evaluation of Global Response (PEGR) [ Time Frame: Week 10-24, 20-48, 30-72, and 40-96 ] [ Designated as safety issue: No ]
    At the end of each injection cycle.

  • Time from last injection session to onset of treatment effect as given by subjective subject assessment [ Time Frame: Up to 4 weeks from last injection session ] [ Designated as safety issue: No ]
    Measured in days.

  • Time from last injection session to waning of treatment effect as rated by subjective subject assessment [ Time Frame: Up to 24 weeks from last injection session ] [ Designated as safety issue: No ]
    Measured in weeks.

  • Duration of treatment effect [ Time Frame: Up to 24 weeks from last injection session ] [ Designated as safety issue: No ]
    Defined as time period within an injection cycle from the day of the injection session until the day where the need for reinjection was indicated by the subject (if subject experienced an onset of treatment effect).

  • Dystonia Discomfort Scale (DDS) score (subject diary), change from baseline [ Time Frame: From study baseline up to week 100 ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: September 2007
Study Completion Date: May 2010
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NT 201 (50-300 Units)
NT 201 (Xeomin®, also know as IncobotulinumtoxinA 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.
Drug: NT 201
Subjects to receive up to 5 injection sessions, with a total dose of up to 300 Units each. No more than 50 units should have be given at any one injection site during one session.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) - total score at baseline > / = 25 with TWSTRS - severity score > / = 10 and TWSTRS - disability score > / = 3
  • Patients must be on a stable dose of other medications
  • For pre-treated patients only: Source documentation of the last two consecutive injection sessions with botulinum neurotoxin type A and stable treatment response directly prior to trial entry
  • For pre-treated patients only: At least 10 weeks must have passed between the last injection session of botulinum neurotoxin type A for cervical dystonia and the time of the baseline visit.
  • For pre-treated patients only: The most recent injection session with botulinum neurotoxin for cervical dystonia must have been at a dose of ≤ 300 units of Botox® or Xeomin®, or ≤ 1,200 units Dysport®.
  • Age > / = 18 and < 76 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00541905

Locations
Germany
Medizinische Hochschule Hannover (LKP)
Hannover, Germany, 30625
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
Investigators
Principal Investigator: Prof. Dirk Dressler, MD Hannover Medical School
  More Information

Publications:
Dressler D, Kupsch A, Paus S, Seitzinger A, Gebhardt B. Sustained efficacy of Incobotulinumtoxin-A (Xeomin®; Botulinum Neurotoxin Type-A, free from Complexing Proteins) in Long-Term Treatment of Cervical Dystonia. European Journal of Neurology 18 (Suppl. 2): 482, 2011.

Responsible Party: Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT00541905     History of Changes
Other Study ID Numbers: MRZ 60201-0605/1, 2006-003410-18
Study First Received: October 8, 2007
Last Updated: June 3, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Torticollis
Central Nervous System Diseases
Dyskinesias
Movement Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 29, 2014