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
Charnele Handy
843-792-8008
handyc@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 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 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

FIGHT: A Phase 3 Randomized, Double-Blind, Controlled Study Evaluating FPA144 and Modified FOLFOX6 in Patients with Previously Untreated Advanced Gastric and Gastroesophageal Cancer: Phase 3 Preceded by Dose-Finding in Phase 1 Save

Date Added
November 30th, 2018
PRO Number
Pro00079574
Researcher
Daniel Reuben

List of Studies

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Keywords
Cancer, Cancer/Gastrointestinal, Drug Studies
Summary

The purpose of this study is to evaluate the safety and effectiveness of a new investigational compound, called FPA144, in combination with chemotherapy (a combination of 5-fluorouracil, oxaliplatin, and leucovorin called mFOLFOX6), for the treatment of gastric and/or gastroesophageal cancer and other solid tumors. The entire study (Phase 1 and Phase 3) is expected to take about 66 months to complete. MUSC is participating in the phase 3 portion only.

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

A Phase Ib Open-Label, Dose-Finding Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Avelumab in Combination with M9241 (NHS-IL12) in Subjects with Locally Advanced, Unresectable, or Metastatic Solid Tumors Save

Date Added
November 27th, 2018
PRO Number
Pro00080265
Researcher
Theodore Gourdin

List of Studies

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

The purpose of this study is to assess how effective the combination of avelumab and NHS-IL12 is in subjects with solid tumors. It will also collect more information on how safe and well-tolerated the combined study drugs are. Subjects will undergo a series of treatment cycles, each lasting 28 days. On Day 1 of each cycle, you will receive NHS IL12 immediately followed by avelumab on scheduled days. You will be assigned to receive avelumab every two weeks or to receive avelumab once a week. Both you and your study doctor will know which dose of study drugs you are receiving during the study.

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

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

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