Text Size

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

This study is currently recruiting participants.
Verified March 2013 by Ipsen
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01753349
First received: December 17, 2012
Last updated: March 31, 2013
Last verified: March 2013
History of Changes
  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:

MedlinePlus related topics: Dystonia
U.S. FDA Resources

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


Estimated Enrollment: 1050
Study Start Date: December 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753349

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

  Show 63 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: March 31, 2013
Health Authority: Australia: Human Research Ethics Committee
Austria: Ethikkommission
Austria: Agency for Health and Food Safety
Belgium: Ethics Committee
China: Ethics Committee
Estonia: Research Ethics Committee
France: French Data Protection Authority
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Hungary: Institutional Ethics Committee
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Italy: Ethics Committee
Latvia: Institutional Review Board
Latvia: State Agency of Medicines
Romania: Ethics Committee
Romania: National Agency for Medicines and Medical Devices
Russia: Ethics Committee
Slovenia: Ethics Committee
Slovenia: Agency for Medicinal Products - Ministry of Health
Sweden: Institutional Review Board
United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on May 16, 2013