NCT00541905

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 8, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2007

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

June 4, 2013

Status Verified

June 1, 2013

Enrollment Period

1.1 years

First QC Date

October 8, 2007

Last Update Submit

June 3, 2013

Conditions

Cervical Dystonia

Outcome Measures

Primary Outcomes (1)

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

    From baseline to week 4

Secondary Outcomes (8)

  • TWSTRS, Single interventional effect

    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

    From study baseline to week 14-28, 24-52, 34-76, and 44-100

  • Global Assessment of Efficacy by Investigator (GAEI)

    Week 10-24, 20-48, 30-72, and 40-96

  • Subject Evaluation of Global Response (PEGR)

    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

    Up to 4 weeks from last injection session

  • +3 more secondary outcomes

Study Arms (1)

NT 201 (50-300 Units)

EXPERIMENTAL

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

Interventions

NT 201DRUG

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.

NT 201 (50-300 Units)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medizinische Hochschule Hannover (LKP)

Hanover, 30625, Germany

Location

Related 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. 2): 482, 2011.

    RESULT

  • 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.

    PMID: 23687362RESULT

MeSH Terms

Conditions

Torticollis

Interventions

incobotulinumtoxinA

Condition Hierarchy (Ancestors)

DystoniaDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Prof. Dirk Dressler, MD

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2007

First Posted

October 10, 2007

Study Start

September 1, 2007

Primary Completion

October 1, 2008

Study Completion

May 1, 2010

Last Updated

June 4, 2013

Record last verified: 2013-06

Locations

DE(1)