A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Trial to Evaluate the Efficacy and Safety of a Single Treatment of DaxibotulinumtoxinA for Injection in Adults with Isolated Cervical Dystonia (ASPEN-1) Save

Date Added
November 13th, 2018
PRO Number
Pro00078538
Researcher
Christine Cooper

List of Studies

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Keywords
Central Nervous System, Drug Studies, Movement Disorders, Muscle, Nerve
Summary

The purpose of this study is to evaluate the safety and effectiveness of daxibotulinumtoxinA for injection (a new investigational study drug) compared to placebo in the treatment of cervical dystonia (CD). DaxibotulinumtoxinA for injection is composed of purified botulinum toxin type A, formulated with a small protein RTP004, and will be used for injection. Placebo means it doesn't contain botulinum toxin type A.

If you are eligible and choose to be in the study, the dose of study drug you receive will depend on the group that you will be put into after randomization at the time of your entry.

You will be assigned, by chance, to 1 of the 3 groups below:
? Group 1: High-dose (250 Units of daxibotulinumtoxinA for injection)
? Group 2: Low-dose (125 Units of daxibotulinumtoxinA for injection)
? Group 3: Placebo (a substance that looks like daxibotulinumtoxinA for injection but has no drug in it)

Study lasts aproximately 39 weeks, including 3 weeks of screening. You will come to the study center up to 12 times during the research study.

The study is being done at approximately 80 sites. Approximately 300 people will take part study-wide and 4 will take part at this institution.

Institution
MUSC
Recruitment Contact
Timothy Sheehan
843-792-0372
sheehant@musc.edu

Brain Circuitry Changes in Vascular Parkinsonism Save

Date Added
July 6th, 2017
PRO Number
Pro00063429
Researcher
Christine Cooper

List of Studies

Silhouette
Keywords
Parkinsons, Vascular
Summary

This study will examine changes in brain architecture that are associated with vascular parkinsonism, in comparison to Parkinson's disease. We will do this by using advanced imaging techniques to compare brain structure between subjects with vascular parkinsonism and Parkinson's disease.

Institution
MUSC
Recruitment Contact
Nancy Feracco
843-792-7859
feracco@musc.edu

An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients with Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes) Save

Date Added
January 26th, 2016
PRO Number
Pro00048197
Researcher
Christine Cooper

List of Studies

Silhouette
Keywords
Movement Disorders, Parkinsons
Summary

This is a prospective, multi-center, open-label, Phase 3 study in Levodopa responsive PD patients with motor fluctuations, designed to evaluate the long-term safety, tolerability and efficacy of APL-130277. APL-130277 is being evaluated as a "rescue" treatment for OFF episodes.

The overall number of subjects is not pre-specified as this is an extension
study.

Patients who have completed any of the following studies: CTH-201,
CTH-203, CTH-300, CTH-301, or CTH-302 will be eligible to enroll into
this study. In addition, approximately one hundred (100) de novo patients
will also be enrolled.

Institution
MUSC
Recruitment Contact
Shonna Fletes
843-795-9115
jenkisho@musc.edu

A Traditional Feasibility study of Gemcitabine, Cisplatin, and 90Y TARE for Unresectable Intrahepatic Cholangiocarcinoma Save

Date Added
July 21st, 2015
PRO Number
Pro00043494
Researcher
Samuel Cooper

List of Studies


Profiles_link
Keywords
Cancer, Cancer/Gastrointestinal
Summary

This study is for adult patients with intrahepatocellular carcinoma. The purpose of this research study is to evaluate the safety and maximum tolerated dose of Gemcitabine and Cisplatin with 90Y TARE. Subjects will have screening tests to determine if he or she is eligible to participate in this study. If the subject is eligible and wishes to enroll, he or she will begin chemotherapy treatment with Gemcitabine and Cisplatin. During the chemotherapy treatment, the patient will receive the 90Y TARE treatment. Study treatment will last up to 8 cycles; each cycle is 21 days. Subjects will be followed after treatment is completed for up to 6 years after treatment started.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A PHASE III TRIAL OF ADJUVANT CHEMOTHERAPY AS PRIMARY TREATMENT FOR LOCALLY ADVANCED CERVICAL CANCER COMPARED TO CHEMORADIATION ALONE: THE OUTBACK TRIAL (ANZGOG 0902/GOG-0274/RTOG 1174) Save

Date Added
March 12th, 2012
PRO Number
Pro00016094
Researcher
Samuel Cooper

List of Studies


Profiles_link
Keywords
Cancer, Cancer/Gynecological
Summary

The objectives of this trial are to find out whether adjuvant chemotherapy (using two other drugs) after chemo-radiation will increase the chances of survival and reduce the risk of tumor recurrence in the pelvis and other places. The risk and severity of side effects and quality of life during and after treatment will also be evaluated and compared. This trial will help the researchers understand the safety and effectiveness of this new treatment regimen for cervical cancer.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzers@musc.edu

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