A Phase 2 Randomized, Multicenter, Double-blind, Vehicle-controlled, 12-Week, Safety, Efficacy, and Systemic Exposure Study followed by a 12-Week Open-label Extension of Trifarotene (CD5789) Cream HE1 in Adults and Adolescents with Autosomal Recessive Ichthyosis with Lamellar Scale Save

Date Added
April 23rd, 2019
PRO Number
Pro00086734
Researcher
Lara Wine lee

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Keywords
Drug Studies, Skin
Summary

This is a multi-center study of the safety and effectiveness of an experimental study drug in treatment of subjects diagnosed with moderate to severe lamellar ichthyosis (LI). The investigational cream will be applied to the surface of the skin in an effort to reduce LI symptoms such as dry and cracked skin. Participation in the study will last 12 weeks (approximately 6 visits) with the option to continue for another 12 weeks (approximately 5 visits) for a total study duration of up to 24 weeks in total. Compensation may be provided.

Institution
MUSC
Recruitment Contact
Abby Powell
843-792-6690
powab@musc.edu

COMT inhibition as a potential therapeutic target among individuals with comorbid Alcohol Use Disorder and Attention-Deficit/Hyperactivity Disorder Save

Date Added
April 2nd, 2019
PRO Number
Pro00086929
Researcher
Joseph Schacht

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Keywords
ADD/ADHD, Alcohol, Drug Studies, Psychiatry
Summary

The purpose of this study is to evaluate the effects of an FDA-approved medication called tolcapone in people who have both Alcohol Use Disorder (AUD) and Attention-Deficit/Hyperactivity Disorder (ADHD). The study involves seven visits over a three to four week period, including an assessment visit and two eight-day medication periods during which participants will be assigned to take, in a double-blinded fashion, both tolcapone and a placebo (three visits during each period). During two of these visits, participants will undergo a one-hour MRI scan. Participants must not be seeking treatment for AUD or ADHD and must not be currently taking any psychotropic medications, including stimulant medications for ADHD. Compensation is available for qualified participants.

Institution
MUSC
Recruitment Contact
Zoe Brasher
(843) 792-7588
brasherz@musc.edu

A Randomized, Phase II Study of Ficlatuzumab with or without Cetuximab in Patients with Cetuximab-Resistant, Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Save

Date Added
March 12th, 2019
PRO Number
Pro00085004
Researcher
John Kaczmar

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Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with Head and Neck Squamous Cell Carcinoma (HNSCC). The investigational drug used in this study is Ficlatuzumab. The main goals of this research study is to study the safety and effectiveness of Ficlatuzumab with or without Cetuximab, to determine which strategy will be more effective, as well as to learn the potential side effects of Ficlatuzumab alone or in combination with Cetuximab. It is unknown exactly how long participants can expect to be in the study. Subjects will receive treatment until the drug is no longer effective on their cancer.

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

A pilot human laboratory study of cannabidiol in Alcohol Use Disorder Save

Date Added
March 5th, 2019
PRO Number
Pro00086168
Researcher
Joseph Schacht

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Keywords
Alcohol, Drug Studies, Psychiatry
Summary

This study will examine the effects of Epidiolex among adults who drink alcohol heavily but who are not seeking treatment for their alcohol use. Epidiolex is an FDA-approved formulation of cannabidiol, the primary non-psychoactive constituent of cannabis. Participants in the study will be randomly assigned to take Epidiolex or placebo for 8 days. There are 3 study visits, including a day-long visit in the laboratory.

Institution
MUSC
Recruitment Contact
Katy Fuqua
(843) 792-1452
fuquama@musc.edu

An Exploratory Investigation Utilizing Repetitive Transcranial Magnetic Stimulation (rTMS) as a Tool to Decrease Pain and Improve Functioning in Veterans with Opioid Use Disorder Save

Date Added
February 5th, 2019
PRO Number
Pro00084970
Researcher
Aimee Mc Rae

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Profiles_link
Keywords
Drug Studies, Substance Use
Summary

The purpose of this study is to determine if repetitive transcranial magnetic stimulation (rTMS) reduces opiate craving and pain in Veterans who are receiving treatment for opioid use disorder. The study will last approximately three months. There will be a screening visit to determine eligibility, followed by the treatment phase during which participants will receive six sessions of rTMS a day for three non-consecutive days. This period may take up to three weeks. There are follow up visits at one week, four weeks and three months after the treatment phase has ended.
During rTMS, focused magnetic waves are directed at a part of the brain that is important in pain, and craving, to increase its activity. If you participate, you will receive six sessions of either active rTMS, or placebo rTMS, each day for three days (18 total sessions). Each session lasts 15 minutes. People typically do not have side effects with rTMS, though they initially may find it mildly painful at the application site. About 1 out of every 20 people who get rTMS have mild headaches after sessions that are typically relieved with over-the-counter medicines. A few people who have had rTMS have had seizures, though the chance of this happening is very small.

Institution
MUSC
Recruitment Contact
Lisa Nunn
843-792-0476
jenkinli@musc.edu

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Assess the Efficacy and Safety of Apremilast (CC 10004) in Pediatric Subjects from 6 through 17 Years with Moderate to Severe Plaque Psoriasis Save

Date Added
January 22nd, 2019
PRO Number
Pro00084118
Researcher
Lara Wine lee

List of Studies

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Keywords
Drug Studies, Pediatrics, Skin
Summary

The purpose of this study is to test and compare the effects of an investigational (being tested) drug called apremilast to placebo in pediatric plaque psoriasis.
Participants who are determined to be eligible to participate will be assigned by chance (or randomized) to treatment with apermilast or placebo. At Week 16, participants will receive apremilast regardless of treatment group. Study and safety assessments, including questionnaires and blood draws, will be completed at study visits. The maximum amount of time participants will be in the study is 71 weeks (at least 19 visits).

Institution
MUSC
Recruitment Contact
Reshil-Marie Dukes
843-792-0387
dukesre@musc.edu

A Phase 1/2 Study for the Safety, Efficacy, Pharmacokinetic and Pharmacodynamics Evaluation of SAR439859, Administered Orally as Monotherapy, Then in Combination With Palbociclib in Postmenopausal Women With Estrogen Receptor-positive Advanced Breast Cancer Save

Date Added
January 22nd, 2019
PRO Number
Pro00084301
Researcher
Antonio Giordano

List of Studies

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Keywords
Cancer/Breast, Drug Studies, Women's Health
Summary

This is an open-label, nonrandomized, dose escalation and dose expansion, safety, efficacy, PK and PD evaluation study of SAR439859 administered orally as monotherapy, then in combination with palbociclib. The study will last approximately 26 months, and participation in the study may last 4 to 8 weeks or longer. The length of participation in this study will depend on how well subjects tolerate the study drug and the condition of their disease.

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

A Phase 2, Multicenter, Single-Arm Trial of CV301 in Combination with PD-1/L1 Blockade in Patients with Locally Advanced or Metastatic Urothelial Bladder Cancer Save

Date Added
January 8th, 2019
PRO Number
Pro00081883
Researcher
Michael Lilly

List of Studies


Profiles_link
Keywords
Bladder, Cancer, Drug Studies, Urinary
Summary

The purpose of this study is to is to investigate the combination of CV301 (an experimental cancer vaccine) with anti-PD-1 Therapy (atezolizumab which was approved for the treatment of advanced Urothelial Bladder Cancer) for treatment of locally advanced or metastatic UC.
CV301 involves the use of a two-component dosing regimen; a prime vaccine, MVA-BN-CV301 (the first vaccine generating a response from your immune system) and a boost vaccine, FPV-CV301 (the second vaccine increasing and maintaining the response of your immune system). Treatment with anti-PD-1 therapy may help the immune system detect and attack cancer cells.
In this clinical trial the use of CV301 vaccine in combination with atezolizumab infusion is being investigated to determine whether the overall survival and immune response observed in subjects treated with atezolizumab can be enhanced when combined with CV301.
This clinical trial is being performed at up to 8 clinical trial sites, and 68 people in total will be selected to participate. The trial is scheduled to last up to 104 weeks from the time you are first seen at the trial site until you start the long-term follow-up contacts. Once deemed eligible for participation, visits are every 3 weeks for the first 16 weeks on study. Then, visits will be every 6 weeks until week 28 on study, at which time visits will be every 12 weeks until end of treatment.
Participation in this trial will not guarantee any direct or immediate benefit, but can help gain future knowledge about the treatment of UC that may be beneficial to others with this disease.

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

A Phase 2b, Open-Label, Single Arm, Multi-Center Study to Assess the Efficacy and Safety of BST-236 as a Single Agent in Adults with Newly-Diagnosed Acute Myeloid Leukemia, Not Eligible for Standard Induction Therapy Save

Date Added
January 8th, 2019
PRO Number
Pro00083544
Researcher
Robert Stuart

List of Studies


Profiles_link
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for subjects with newly-diagnosed acute myeloid leukemia (AML) who are not eligible for standard induction chemotherapy. The investigational drug in this study is BST-236, which is given via IV. The purpose of this research study is to measure the safety of BST-236 and how effective it is in treating subjects. Visits will be required for 6 consecutive days during each cycle of treatment. The number of courses you receive will depend on whether you are benefiting from the study drug. Participants can expect to be in this study for 2 years (including treatment and post study follow-up).

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

A Phase 3, Open-Label, Multi-Center Trial to Evaluate the Long-Term Safety and Efficacy of Repeat Treatments of DaxibotulinumtoxinA for Injection in Adults with Isolated Cervical Dystonia (ASPEN-OLS) Save

Date Added
December 11th, 2018
PRO Number
Pro00078648
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.

If you are eligible and choose to be in the study, the dose of study drug you receive (125 units or 250 units) will depend on your clinical assessment, the severity of your disease, and whether you have had any toxin before.

The study may last up to 55 weeks, including 3 weeks of screening. You will come to the study center up to 15 times.

The study is being done at approximately 80 sites. Approximately 290 adults with moderate to severe isolated CD, who are 18-80 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

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