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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

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

NCT ID

NCT00541905

First Posted

October 8, 2007

Last Updated

June 3, 2013

Sponsor

Merz Pharmaceuticals GmbH

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

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

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

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

Learn more about this trial

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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