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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

Primary Purpose

Cervical Dystonia

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
NT 201
Sponsored by
Merz Pharmaceuticals GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Dystonia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medizinische Hochschule Hannover (LKP)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NT 201 (50-300 Units)

Arm Description

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.

Outcomes

Primary Outcome Measures

Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), total score: Change from study baseline (initial injection session) to week 4

Secondary Outcome Measures

TWSTRS, Single interventional effect
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
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)
At the end of each injection cycle
Subject Evaluation of Global Response (PEGR)
At the end of each injection cycle.
Time from last injection session to onset of treatment effect as given by subjective subject assessment
Measured in days.
Time from last injection session to waning of treatment effect as rated by subjective subject assessment
Measured in weeks.
Duration of treatment effect
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

Full Information

First Posted
October 8, 2007
Last Updated
June 3, 2013
Sponsor
Merz Pharmaceuticals GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00541905
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merz Pharmaceuticals GmbH

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Dystonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NT 201 (50-300 Units)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
NT 201
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
TWSTRS, Single interventional effect
Description
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.
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
Title
TWSTRS, overall interventional effect
Description
Measured by the change in the TWSTRS total, severity and disability scores, from study baseline to each examination 4 weeks after the injection sessions
Time Frame
From study baseline to week 14-28, 24-52, 34-76, and 44-100
Title
Global Assessment of Efficacy by Investigator (GAEI)
Description
At the end of each injection cycle
Time Frame
Week 10-24, 20-48, 30-72, and 40-96
Title
Subject Evaluation of Global Response (PEGR)
Description
At the end of each injection cycle.
Time Frame
Week 10-24, 20-48, 30-72, and 40-96
Title
Time from last injection session to onset of treatment effect as given by subjective subject assessment
Description
Measured in days.
Time Frame
Up to 4 weeks from last injection session
Title
Time from last injection session to waning of treatment effect as rated by subjective subject assessment
Description
Measured in weeks.
Time Frame
Up to 24 weeks from last injection session
Title
Duration of treatment effect
Description
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).
Time Frame
Up to 24 weeks from last injection session
Title
Dystonia Discomfort Scale (DDS) score (subject diary), change from baseline
Time Frame
From study baseline up to week 100

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Dirk Dressler, MD
Organizational Affiliation
Hannover Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Hochschule Hannover (LKP)
City
Hannover
ZIP/Postal Code
30625
Country
Germany

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
result
PubMed Identifier
23687362
Citation
Dressler D, Paus S, Seitzinger A, Gebhardt B, Kupsch A. Long-term efficacy and safety of incobotulinumtoxinA injections in patients with cervical dystonia. J Neurol Neurosurg Psychiatry. 2013 Sep;84(9):1014-9. doi: 10.1136/jnnp-2012-303608. Epub 2013 May 18.
Results Reference
result

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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

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