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.
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.
CCTG 595: A Multicenter, Randomized Study of Text Messaging to Improve Adherence to PrEP in Risky MSM
A total of 400 HIV-uninfected men who have sex with men (MSM)and male to female (M to F)
transgender individuals with recent high-risk transmission behavior will be enrolled into
the study. Each subject will be followed for up to 48 weeks after enrollment of the last
subject. The primary endpoint will be measured at 48 weeks.
All subjects will start PrEP with TDF + FTC fixed dose combination given once daily.
Subjects will be randomized (1:1) to either the iTAB text messaging adherence reminder
intervention with SoC or the SoC alone arm. Subjects placed into the iTAB intervention arm
will receive a personalized, automated texting system to maintain adherence and retention.
Both groups will receive access to PrEP in accordance with standardized comprehensive
methods of prescribing, risk reduction counseling, adherence counseling, and clinical
assessments that include safety monitoring, as well as HIV and STD screening.
TDF 300 mg + FTC 200 mg fixed dose combination will be given orally once daily starting at
the baseline visit (month 0) and continued throughout the study.
Assessing brain response to sugar
This study is aimed at understanding brain and hunger responses to different types of sugars and how this influences feeding behavior in lean and obese people.
A Phase 3, Long-Term, Open-Label and Single-Arm Study of MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects
Multicenter, open-label, outpatient study of the safety and effectiveness of repeated doses
of MYOBLOC over a 1-year duration in adult subjects with troublesome sialorrhea. The primary
goal is to determine the long-term safety and tolerability of MYOBLOC (administered
intraglandularly as single total dose of 3,500 Units) treatments every 13 weeks over a
maximum possible duration of 1 year in adult subjects with troublesome sialorrhea. The
secondary goal is to assess the magnitude of therapeutic response of MYOBLOC (administered
intraglandularly as a single total dose of 3,500 Units) using effectiveness assessments
performed at intervals after treatments every 13 weeks over a maximum possible duration of 1
year.
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