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Study Title Principal Investigator
CD Flex: An Open-Label, Non-Inferiority Study Evaluating the Efficacy and Safety of Two Injection Schedules of Xeomin (incobotulinumtoxinA) [Short Flex vs. Long Flex] in Subjects with Cervical Dystonia with < 10 Weeks of Benefit from OnabotulinumtoxinA Treatment MUS 60201 4073 1
Dystonia is a movement disorder characterized by sustained, involuntary muscle contractions which frequently causes twisting and repetitive movements or abnormal postures. Cervical dystonia (CD) is the most commonly described form of focal dystonia (abnormality involving a single area of the body). Xeomin (botulinum toxin type A), the study drug, has been shown to be effective and safe in the treatment of CD with two Phase III trials. Current practice in the treatment of CD with onabotulinumtoxinA (Botox) injection is to inject patients every 3 months. However, not all patients receive benefit from injections for the duration of 3 months. This study is designed to examine a shorter treatment interval with Xeomin injections and compare to the standard interval to determine if there is a difference from an efficacy standpoint (i.e., do the patients receive continuous benefit versus peaks and valleys) and if more frequent dosing leads to more development of botulinum toxin resistance. This study will evaluate if shorter dosing intervals is non-inferior to standard or longer dosing intervals by using the Toronto Western Spasmodic Torticollis Scale (TWSTRS) at control Visit 4 weeks post the the 8th injection. Secondary outcomes will evaluate efficacy, onset and offste of efficacy, safety and immunology. The primary efficacy variable will be defined as the change from study entry baseline in the TWSTRS-Severity score assessed at the 4-week control visti after the 8th injection (PPS sample). An analysis of covariance (ANCOVA) will be used for the primary efficacy analysis. All analysis of secondary endpoints for efficacy will be considered exploratory.
Active, not recruiting | Dystonia | Multisite
Jennifer Hui
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A PHASE IIIb, MULTICENTRE, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF DYSPORT USING 2 mL DILUTION IN ADULTS WITH CERVICAL DYSTONIA A-TL-52120-169
A multicentre, randomised, double blind, placebo controlled study where at study entry, subjects will be randomised in a ratio of 2:1 to receive either Dysport or placebo. The primary objective of the study is to evaluate the efficacy and safety of Dysport 500 units (U)/vial using 2 mL dilution compared with placebo for the treatment of cervical dystonia (CD). All subjects are planned to have a single treatment in this study. Following study treatment, follow up visits will be performed at Week 2, Week 4 and Week 12 (+28 days/4 weeks) or early withdrawal due to any reason. All subjects who complete the Week 12 visit will be considered to have completed the study and will be offered entry into an open label extension (OLE) study, which consists of up to three treatment cycles of Dysport using the 2 mL dilution scheme. Between Weeks 4 and 8, subjects may be deemed eligible for early entry into the OLE study, i.e. before they reach the planned Week 12 study visit if rescue treatment is needed. Approximately 132 male and female subjects with CD will be enrolled. The primary efficacy endpoint is the change from baseline in TWSTRS total score at Week 4. Clinical Trial Rationale:The current USPI allows for only one dilution of Dysport: 500 U in 1 mL volume. Feedback obtained from scientific experts and Investigators at medical advisory boards and in market research data has pointed to the lack of scientific data supporting a 2 mL dilution as an obstacle to providing appropriate, safe and effective Dysport utilisation in the USA for subjects suffering from CD. Despite the lack of labelled information, the 2 mL dilution with Dysport reflects real world clinical practice in the USA.The addition of data in the USPI supporting the safety and efficacy of a 2 mL dilution with Dysport will provide the clinician more flexibility in injection volume range to better equip them to meet the needs of a broader spectrum of subjects with CD. Therefore, in this clinical study the majority of enrolled subjects will be previously treated with Botox to reflect the real world clinical scenario in the USA.Statistical analyses will be performed by an external CRO. Statistical evaluation will be performed by using SAS. Exploratory analysis will be performed for each of the tertiary secondary efficacy endpoints using appropriate methods.
Active, not recruiting | Dystonia | Multisite
Jennifer Hui
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A Phase 3b, Prospective, Multicenter, Open-Label Extension Study to Assess Long Term Safety and Efficacy of DYSPORT Using 2mL Dilution in Adults with Cervical Dystonia
A phase 3b, prospective, multicenter, open-label extension study to assess the long term safety and effectiveness of Dysport using 2 mL dilution in adults with cervical dystonia. This study is open to subjects who have completed the Dysport double-blind study protocol A-TL-52120-169 or are eligible for early entry, from enrollment into the 169 study.Clinical Trial Rationale:The current USPI allows for only one dilution of Dysport: 500 U in 1 mL volume. Feedback obtained from scientific experts and Investigators at medical advisory boards and in market research data has pointed to the lack of scientific data supporting a 2 mL dilution as an obstacle to providing appropriate, safe and effective Dysport utilisation in the USA for subjects suffering from CD. Despite the lack of labelled information, the 2 mL dilution with Dysport reflects real world clinical practice in the USA.The addition of data in the USPI supporting the safety and efficacy of a 2 mL dilution with Dysport will provide the clinician more flexibility in injection volume range to better equip them to meet the needs of a broader spectrum of subjects with CD. The primary objective of the study is to assess long term safety of repeat treatment cycles of Dysport 500 units (U)/vial using 2 mL dilution scheme for the treatment of cervical dystonia (CD). Secondary objective is to assess long term efficacy of repeat treatment cycles of Dysport 500 units (U)/vial using 2 mL dilution scheme for the treatment of cervical dystonia (CD). The study consists of up to three treatment cycles of Dysport using the 2 mL dilution scheme. Approximately 132 male and female subjects with CD will be enrolled. The primary efficacy endpoint is the change from treatment cycle baseline (defined as Day 1 in each cycle) in TWSTRS total score at Week 4 and Week 12 visits, in Treatment Cycles 1, 2, and 3. Statistical analyses will be performed by an external CRO. Statistical evaluation will be performed by using SAS.
Enrolling by invitation | Dystonia | Multisite
Jennifer Hui
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Presentado por SC CTSI