Overview

This trial is active, not recruiting.

Condition cervical dystonia
Treatment bont-a injections, 3-4 times yearly
Sponsor Ipsen
Start date December 2012
End date July 2017
Trial size 1050 participants
Trial identifier NCT01753349, Y-79-52120-166

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Adults subjects from Hospitals, Private Practices suffering idiopathic cervical dystonia.
bont-a injections, 3-4 times yearly

Primary Outcomes

Measure
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.

Secondary Outcomes

Measure
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.
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.

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Ipsen.