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NCT Number: NCT00541905

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

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.

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Key information

Conditions

Cervical Dystonia Dyskinesias Dystonia Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Torticollis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medizinische Hochschule Hannover (LKP)

Hanover, 30625, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NT 201

Drug

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 outcomes

  1. 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

  1. TWSTRS, Single interventional effect

    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

    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.

  2. TWSTRS, overall interventional effect

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

    Measured by the change in the TWSTRS total, severity and disability scores, from study baseline to each examination 4 weeks after the injection sessions

  3. Global Assessment of Efficacy by Investigator (GAEI)

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

    At the end of each injection cycle

  4. Subject Evaluation of Global Response (PEGR)

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

    At the end of each injection cycle.

  5. Time from last injection session to onset of treatment effect as given by subjective subject assessment

    Time frame: Up to 4 weeks from last injection session

    Measured in days.

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

    Time frame: Up to 24 weeks from last injection session

    Measured in weeks.

  7. Duration of treatment effect

    Time frame: Up to 24 weeks from last injection session

    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).

  8. Dystonia Discomfort Scale (DDS) score (subject diary), change from baseline

    Time frame: From study baseline up to week 100

Sponsors and collaborators

Lead sponsor

Merz Pharmaceuticals GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2010
First posted
Oct 10, 2007
Registry last updated
Jun 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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