Phase IV-Cervical Dystonia-INTEREST IN CD2 (INTEREST_INCD2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01753349
First received: December 17, 2012
Last updated: September 30, 2014
Last verified: September 2014
  Purpose

The purpose of the study is to document long-term response in real-life practice after injection cycles with BoNT-A in subjects suffering from idiopathic cervical dystonia (Long-term clinical and pharmaco-economic data).


Condition Intervention
Cervical Dystonia
Drug: BoNT-A injections, 3-4 times yearly

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An International Observational Prospective Study On Long-Term Response To Botulinum Toxin Type A (BoNT-A) Injections In Subjects Suffering From Idiopathic Cervical Dystonia (CD) - Pharmaco-Economic Impact

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Change in subject's satisfaction using a 5-point Likert scale. [ Time Frame: Baseline and at every 3 to 4 months, up to 3 years. ] [ Designated as safety issue: No ]
    Identification of prognostic factors for subject's satisfaction regarding control of symptoms associated with idiopathic CD.


Secondary Outcome Measures:
  • Change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score and severity sub-scale. [ Time Frame: Baseline and at every 3 to 4 months, up to 3 years. ] [ Designated as safety issue: No ]
    Assessment of severity of CD.

  • Change in tremor associated with CD using Tsui score [ Time Frame: Baseline and at every 3 to 4 months, up to 3 years. ] [ Designated as safety issue: No ]
  • Change in pain relief assessed using the TWSTRS pain sub-scale. [ Time Frame: Baseline and at every 3 to 4 months, up to 3 years. ] [ Designated as safety issue: No ]
  • Change in disability will be measured with the TWSTRS disability sub-scale. [ Time Frame: Baseline and at every 3 to 4 months, up to 3 years. ] [ Designated as safety issue: No ]
  • Pharmaco-economic endpoints [ Time Frame: Baseline and at every 3 to 4 months, up to 3 years. ] [ Designated as safety issue: No ]
    • Time intervals between injections
    • Changes in concomitant treatments for CD and associated symptoms.
    • Changes in employment status


Enrollment: 114
Study Start Date: December 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Idiopathic cervical dystonia
Adults subjects from Hospitals, Private Practices suffering idiopathic cervical dystonia.
Drug: BoNT-A injections, 3-4 times yearly

  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

Adult subjects from Hospitals, Private Practices suffering idiopathic cervical dystonia.

Criteria

Inclusion Criteria:

  • Subject for whom there is an intention to treat with BoNT-A.
  • BoNT treatment naïve or previously treated with BoNT.
  • If previously treated with BoNT, at least a 12-week interval between the last injection (BoNT-A or BoNT-B) and inclusion.
  • Subject able to comply with the protocol.
  • Provision of written informed consent prior to collect the data.

Exclusion Criteria:

  • Contraindications to any BoNT-A preparations.
  • The subject has already been included in the study.
  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: NCT01753349

  Show 115 Study Locations
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Savary Om, M.D. Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01753349     History of Changes
Other Study ID Numbers: Y-79-52120-166
Study First Received: December 17, 2012
Last Updated: September 30, 2014
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Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Torticollis
Central Nervous System Diseases
Dyskinesias
Movement Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014