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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Ipsen Identifier:
First received: December 17, 2012
Last updated: September 30, 2016
Last verified: September 2016
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: 1050
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.

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 identifier: NCT01753349

  Show 113 Study Locations
Sponsors and Collaborators
Study Director: Savary Om, M.D. Ipsen
  More Information

Responsible Party: Ipsen Identifier: NCT01753349     History of Changes
Other Study ID Numbers: Y-79-52120-166 
Study First Received: December 17, 2012
Last Updated: September 30, 2016
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
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Lebanon: Ministry of Public Health
Poland: Ethics Committee
Malaysia: Institutional Review Board
Turkey: Ethics Committee
Taiwan: Institutional Review Board
Mexico: Federal Commission for Protection Against Health Risks
Mexico: Ethics Committee
Portugal: Health Ethic Committee
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Serbia: Ethics Committee
Brazil: Ethics Committee
Egypt: Ministry of Health, Drug Policy and Planning Center
Israel: Ethics Commission
Philippines: Ethics Committee
Philippines : Food and Drug Administration
Singapore: Health Sciences Authority
Singapore: Institutional Review Board
Thailand: Ethical Committee
United States: Institutional Review Board
Jordan: Jordanian Food and Drug Administration
Jordan: Ethical Committee
Algeria: Ministry of Health
United Arab Emirates: Ethical Committee

Additional relevant MeSH terms:
Dystonic Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents processed this record on December 02, 2016