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. (see Contacts and Locations)
Verified July 2014 by Ipsen
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01840462
First received: April 23, 2013
Last updated: July 28, 2014
Last verified: July 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 28, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Agency for Health and Food Safety

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 August 26, 2014