Longitudinal Study for Treatment With Botulinum Toxin A Injections in naïve and Pre-treated Patients Suffering From Cervical Dystonia [CD-NIS-Longterm] (CDNISLongterm)

This study is currently recruiting participants.
Verified March 2014 by Ipsen
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01840462
First received: April 23, 2013
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

The objective of this study is to investigate the efficacy of Dysport® in the treatment of cervical dystonia (CD) in a non-interventional long-term study in naïve and pre-treated patients.


Condition
Cervical Dystonia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A National, Multicenter, Non-interventional, Prospective, Longitudinal Study for Treatment With Botulinum Toxin A Injections in naïve and Pre-treated Patients Suffering From Cervical Dystonia (Dysport®)

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Change in Tsui scores [ Time Frame: Baseline and 12 weeks post-injection Cycle 2 ] [ Designated as safety issue: No ]
    The Tsui rating scale is a disease-specific score to evaluate the severity of CD taking the clinical signs of CD into account in a standardised manner.


Secondary Outcome Measures:
  • Change in Tsui scores [ Time Frame: Baseline and 12 weeks post-injection Cycle 1 ] [ Designated as safety issue: No ]
    The Tsui rating scale is a disease-specific score to evaluate the severity of CD taking the clinical signs of CD into account in a standardised manner.

  • Change in Tsui scores [ Time Frame: Baseline and 12 weeks post-injection Cycle 3 ] [ Designated as safety issue: No ]
    The Tsui rating scale is a disease-specific score to evaluate the severity of CD taking the clinical signs of CD into account in a standardised manner.

  • Change in Tsui scores [ Time Frame: Baseline and 12 weeks post-injection Cycle 4 ] [ Designated as safety issue: No ]
    The Tsui rating scale is a disease-specific score to evaluate the severity of CD taking the clinical signs of CD into account in a standardised manner.


Estimated Enrollment: 360
Study Start Date: July 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Subjects naïve to botulinum toxin A (BoNT-A) treatment
Patients naïve to botulinum toxin A treatment
Subjects pre-treated with botulinum toxin A (BoNT-A) injection

Patients pre-treated with botulinum toxin A for at least 2 years.

4 injection cycles, each at 3 to 4 months intervals. Investigators follow their individual injection protocol for the treatment with BoNT-A (modalities of administration in accordance with local Summary of Product Characteristics).


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients suffering from cervical dystonia

Criteria

Inclusion Criteria:

  • Suffering from cervical dystonia with rotational torticollis/-caput or laterocollis/-caput as the primary component
  • Naïve to botulinum toxin A or pre-treated with botulinum toxin A on a regular basis for at least 2 years prior to inclusion and last injection with Dysport® and last injection between 3 and 6 months prior to inclusion
  • With the intention to be treated with Dysport®

Exclusion Criteria:

  • The subject has already been included in this study
  • Participation in an interventional trial
  • Suffering from anterocollis or retrocollis as primary component
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01840462

Contacts
Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com

Locations
Austria
Recruiting
Graz, Austria
Germany
Recruiting
Wiesbaden, Germany
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Andrea Reissig, PhD. Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01840462     History of Changes
Other Study ID Numbers: A-94-52120-165
Study First Received: April 23, 2013
Last Updated: March 27, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Torticollis
Dystonia
Dystonic Disorders
Stress, Psychological
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Behavioral Symptoms
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014