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

June 3, 2013 updated by: Merz Pharmaceuticals GmbH

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover (LKP)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From baseline to week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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
TWSTRS, overall interventional effect
Time Frame: From study baseline to week 14-28, 24-52, 34-76, and 44-100
Measured by the change in the TWSTRS total, severity and disability scores, from study baseline to each examination 4 weeks after the injection sessions
From study baseline to week 14-28, 24-52, 34-76, and 44-100
Global Assessment of Efficacy by Investigator (GAEI)
Time Frame: Week 10-24, 20-48, 30-72, and 40-96
At the end of each injection cycle
Week 10-24, 20-48, 30-72, and 40-96
Subject Evaluation of Global Response (PEGR)
Time Frame: Week 10-24, 20-48, 30-72, and 40-96
At the end of each injection cycle.
Week 10-24, 20-48, 30-72, and 40-96
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
Measured in days.
Up to 4 weeks from last injection session
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
Measured in weeks.
Up to 24 weeks from last injection session
Duration of treatment effect
Time Frame: Up to 24 weeks from last injection session
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).
Up to 24 weeks from last injection session
Dystonia Discomfort Scale (DDS) score (subject diary), change from baseline
Time Frame: From study baseline up to week 100
From study baseline up to week 100

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merz Pharmaceuticals GmbH

Investigators

  • Principal Investigator: Prof. Dirk Dressler, MD, Hannover Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

October 8, 2007

First Submitted That Met QC Criteria

October 8, 2007

First Posted (Estimate)

October 10, 2007

Study Record Updates

Last Update Posted (Estimate)

June 4, 2013

Last Update Submitted That Met QC Criteria

June 3, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRZ 60201-0605/1
  • 2006-003410-18 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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