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

Cervical Dystonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00541905
• Other study ID #: MRZ 60201-0605/1
• Secondary ID: 2006-003410-18
• Status: Completed
• Phase: Phase 4
• First received: October 8, 2007
• Last updated: June 3, 2013
• Start date: September 2007
• Est. completion date: May 2010

Study information

• Verified date: June 2013
• Source: Merz Pharmaceuticals GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: May 2010
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Dystonia
• Dystonia
• Dystonic Disorders
• Torticollis

Intervention

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.

Locations

Country	Name	City	State
Germany	Medizinische Hochschule Hannover (LKP)	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
Merz Pharmaceuticals GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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.

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), total score: Change from study baseline (initial injection session) to week 4		From baseline to week 4	No
Secondary	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.	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	No
Secondary	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	From study baseline to week 14-28, 24-52, 34-76, and 44-100	No
Secondary	Global Assessment of Efficacy by Investigator (GAEI)	At the end of each injection cycle	Week 10-24, 20-48, 30-72, and 40-96	No
Secondary	Subject Evaluation of Global Response (PEGR)	At the end of each injection cycle.	Week 10-24, 20-48, 30-72, and 40-96	No
Secondary	Time from last injection session to onset of treatment effect as given by subjective subject assessment	Measured in days.	Up to 4 weeks from last injection session	No
Secondary	Time from last injection session to waning of treatment effect as rated by subjective subject assessment	Measured in weeks.	Up to 24 weeks from last injection session	No
Secondary	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).	Up to 24 weeks from last injection session	No
Secondary	Dystonia Discomfort Scale (DDS) score (subject diary), change from baseline		From study baseline up to week 100	No