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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) - Pharmacoeconomic Impact

PHRR140421-000191

IPSEN Interest in CD2

2013-CT0102

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) - pharmacoeconomic impact

Focal dystonias are defined as abnormal co-contractions of agonist and antagonist muscles leading to torsion of body parts and abnormal postures. Cervical dystonia (CD) is the most common of the focal dystonias (1). The prevalence is reported to be 89 per million in Rochester, Minnesota, US (2) and 57 per million of the population in eight European countries (3). BoNT-A is established as safe and effective for the treatment of CD according to robust and well-designed clinical trials (4) in highly selected patients, which may not relate to real-life practice with individualized patients. The INTEREST IN CD group conducted an observational study to document response in real-life practice after one injection cycle with BoNT-A (5). Long-term clinical and pharmaco-economic data in real-life practice are needed.

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2013-10-01 36 2016-10-01 0000-00-00

Completed

Institution Classification Region LTO #
Ipsen Pharma SAS Private Business France CDRR-NCR-CRO-11
Institution Classification Region LTO #
Novotech (Australia) Pty. Ltd. - Philippine Branch Private Business NCR CDRR-NCR-CRO-11
Institution Amount Region
Ipsen Pharma SAS N/A France
Name E-Mail Phone Number Postal Address
Franchette (Shey) Dulfo Shey.Dulfo@novotech-cro.com +63 2 883 52 20 Room 1912, 19/F Marco Polo Ortigas Manila, Sapphire Road, Ortigas Center, Pasig Metro Manila 1600 Philippines
Name E-Mail Phone Number Postal Address
Franchette A. Dulfo Shey.Dulfo@novotech-cro.com +63 2 883 52 20 Room 1912, 19/F Marco Polo Ortigas Manila, Sapphire Road, Ortigas Center, Pasig Metro Manila 1600 Philippines
Name Expertise Affiliation
Raymond L. Rosales, MD Principal Investigator Metropolitan Medical Center
Roland Dominic G. Jamora, MD Principal Investigator St. Luke's Medical Center - Quezon City, Institute of Neurosciences
Project Location Institutional Ethics Review Board
Metropolitan Medical Center Institutional Review Board of Metropolitan Medical Center, Inc.
St. Luke's Medical Center - Quezon City, Institute of Neurosciences N/A

Cervical Dystonia

To document long term subject’s satisfaction regarding control of symptoms associated with idiopathic Cervical dystonia (CD) and to identify prognostic factors for satisfaction on a large cohort.

Secondary objective(s) ‾ To describe baseline demographics ‾ To describe history of CD ‾ To describe severity of CD ‾ To document tremor associated with CD ‾ To describe pain relief ‾ To describe disability ‾ To document changes in head/neck deviation patterns ‾ To document anatomic location of dystonia ‾ To describe injection practices Pharmaco-economic objectives ‾ To document time intervals between injections ‾ To document changes in concomitant treatments for CD and associated symptoms ‾ To describe changes in employment status

Completed

  • Algeria
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • China
  • Czech Republic
  • Egypt
  • Estonia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Jordan
  • Latvia
  • Lebanon
  • Malaysia
  • Mexico
  • Philippines
  • Poland
  • Portugal
  • Romania
  • Russia
  • Serbia
  • Singapore
  • Slovenia
  • South Korea
  • Sweden
  • Taiwan
  • Thailand
  • Turkey
  • United Arab Emirates
  • United Kingdom
  • United States

Clinical Trial

2013-CT0102

2013-08-28

Date Amendment Classification Reason
2015-09-14 Amendments related to the protocol
2014-04-16 Amendments related to the protocol

Inclusion All subjects must fulfil the following: – Male or female ≥ 18 years old, – Suffering from idiopathic CD, – For whom there is an intention to treat with BoNT-A for CD – 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 Subjects will not be included in the Study if the subject has any: – Contraindications to any BoNT-A preparations, – The subject has already been included in the Study.

Observational

Unspecified

Unspecified

Unspecified

Open Label

Unspecified

Not Applicable

Focal dystonias are defined as abnormal co-contractions of agonist and antagonist muscles leading to torsion of body parts and abnormal postures. Cervical dystonia (CD) is the most common of the focal dystonias (1). The prevalence is reported to be 89 per million in Rochester, Minnesota, US (2) and 57 per million of the population in eight European countries (3). BoNT-A is established as safe and effective for the treatment of CD according to robust and well-designed clinical trials (4) in highly selected patients, which may not relate to real-life practice with individualized patients. The INTEREST IN CD group conducted an observational study to document response in real-life practice after one injection cycle with BoNT-A (5). Long-term clinical and pharmaco-economic data in real-life practice are needed.

Phase IV

16

23

Sample was reallocated to Philippine sites to meet the global recruitment target

01 Oct 2013

Utilization Utilization Info
Publication

Planned

Oral Presentation

Planned

Drug Literature

Planned (Abstracts only)

Posters

Planned

Others

Planned (Meta-Analyses with two (2) other CD studies)

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