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

Merz Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Cervical Dystonia

Treatments: Drug: NT 201

Study type: Interventional

Funder types: Industry

Identifiers

NCT00541905

MRZ 60201-0605/1

2006-003410-18 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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82 participants in 1 patient group

NT 201 (50-300 Units)

Experimental group

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.

Treatment:

Drug: NT 201