Phase IV-Cervical Dystonia-INTEREST IN CD2

Completed

• Conditions: Cervical Dystonia

• Registration Number: NCT01753349
• Lead Sponsor: Ipsen

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-17
• Study First Submitted QC: 2012-12-17
• Study First Posted: 2012-12-20
• Primary Completion: 2017-09
• Study Completion: 2017-09-25
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-04
• Last Update Posted: 2020-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1050

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in subject's satisfaction using a 5-point Likert scale.	Baseline and at every 3 to 4 months, up to 3 years.	Identification of prognostic factors for subject's satisfaction regarding control of symptoms associated with idiopathic CD.

Secondary Outcome Measures

Name	Time	Method
Change in tremor associated with CD using Tsui score	Baseline and at every 3 to 4 months, up to 3 years.
Change in disability will be measured with the TWSTRS disability sub-scale.	Baseline and at every 3 to 4 months, up to 3 years.
Change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score and severity sub-scale.	Baseline and at every 3 to 4 months, up to 3 years.	Assessment of severity of CD.
Change in pain relief assessed using the TWSTRS pain sub-scale.	Baseline and at every 3 to 4 months, up to 3 years.
Pharmaco-economic endpoints	Baseline and at every 3 to 4 months, up to 3 years.	* Time intervals between injections; * Changes in concomitant treatments for CD and associated symptoms.; * Changes in employment status

Trial Locations

Locations (113)

Parkinson's and Movement Disorders Center of Maryland; 🇺🇸 Elkridge, Maryland, United States

Tufts Medical Center, Inc; 🇺🇸 Boston, Massachusetts, United States

The Parkinson's and Movement Disorders Center; 🇺🇸 Southfield, Michigan, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States

Bab El Oued Hospital; 🇩🇿 Alger, Algeria

Sidi Bel Abbes Hospital; 🇩🇿 Alger, Algeria

Ben Badis Hospital; 🇩🇿 Constantine, Algeria

Austin Hospital; 🇦🇺 Heidelberg, Victoria, Australia

Alfred Hospital,; 🇦🇺 Melbourne, Australia

Dandenong Neurology; 🇦🇺 Melbourne, Australia

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