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

Phase 4CompletedNCT00541905

Merz Pharmaceuticals GmbH82 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cervical Dystonia

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Medizinische Hochschule Hannover (LKP)

Hanover, Germany

Outcomes

Primary Outcomes

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 Outcomes

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.

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

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

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

Global Assessment of Efficacy by Investigator (GAEI)

At the end of each injection cycle

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

Subject Evaluation of Global Response (PEGR)

At the end of each injection cycle.

Time frame: 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

Measured in days.

Time frame: Up to 4 weeks from last injection session

Time from last injection session to waning of treatment effect as rated by subjective subject assessment

Measured in weeks.

Time frame: Up to 24 weeks from last injection session

Data from ClinicalTrials.gov

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