Phase IV-Cervical Dystonia-INTEREST IN CD2 (INTEREST_INCD2)
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|ClinicalTrials.gov Identifier: NCT01753349|
Recruitment Status : Completed
First Posted : December 20, 2012
Last Update Posted : December 5, 2017
|Condition or disease||Intervention/treatment|
|Cervical Dystonia||Drug: BoNT-A injections, 3-4 times yearly|
|Study Type :||Observational|
|Actual Enrollment :||1050 participants|
|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|
|Actual Study Start Date :||December 2012|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||September 25, 2017|
Idiopathic cervical dystonia
Adults subjects from Hospitals, Private Practices suffering idiopathic cervical dystonia.
|Drug: BoNT-A injections, 3-4 times yearly|
- 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. ]Identification of prognostic factors for subject's satisfaction regarding control of symptoms associated with idiopathic CD.
- 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. ]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. ]
- 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. ]
- 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. ]
- Pharmaco-economic endpoints [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01753349
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|Study Director:||Savary Om, M.D.||Ipsen|