A Phase II, 8-week-treatment, multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy, tolerability and safety of orally administered BI 1358894 in patients with Post-Traumatic Stress Disorder (PTSD)

Date Added
January 10th, 2023
PRO Number
Pro00124053
Researcher
Mark Hamner

List of Studies


Keywords
Depression, Drug Studies, Mental Health, Military, Psychiatry, Stage II
Summary

While there are medications for PTSD, they don't treat all the symptoms and only affect the severity of some symptoms instead of reducing symptoms overall. As a result, you may be considering other options for your PTSD.

One option to consider is this clinical research study of an oral investigational drug for adults diagnosed with PTSD. In this study, doctors want to evaluate the safety and effectiveness of the investigational drug and compare it to a placebo, which looks like the investigational drug but contains no active medicine. The investigational drug has been studied in clinical research studies before, but it is not approved to treat PTSD. People with PTSD can only receive the investigational drug in clinical research studies like this one.

The results of this study will provide more information about the
investigational drug and whether it could one day be prescribed to
treat PTSD.

If you are eligible for this study and agree to participate, you will be randomly assigned (like the flip of a coin) to receive the investigational drug or placebo. You have an equal chance of receiving either study drug (investigational or placebo).

You, the study doctor and the study staff will not know which study drug you are receiving. However, in the event of an emergency, this information can be provided.

You will take your assigned study drug once a day for 8-weeks. You will attend up to 8 study center visits for tests, procedures, interviews, and questionnaires to evaluate your health and PTSD. You will also receive 4 phone or video calls from the study doctor/staff to talk about how you are feeling.

Your total study participation will last approximately 16 weeks, which includes screening for eligibility, study drug dosing, and follow-up.

Institution
MUSC
Recruitment Contact
Katelyn Prowell
478-319-6648
prowell@lcvresearch.org

Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs. Radiotherapy with Concurrent Cetuximab in Patients with Locoregionally Advanced Head and Neck Cancer with a Contraindication to Cisplatin

Date Added
May 18th, 2018
PRO Number
Pro00077581
Researcher
David Marshall

List of Studies


Keywords
Cancer, Cancer/Head & Neck, Stage II, Stage III
Summary

This study is for patients that have been diagnosed with stage III-IVB Head and Neck cancer. The investigational drug in this study is MEDI4736 (Durvalumab). The purpose of the safety lead-in portion of the study is to determine whether adding the study drug MEDI4736 to radiation is safe in patients with head and neck cancer who cannot take the drug cisplatin. The purpose of the phase II/III portion is to compare any good and bad effects of usual radiation plus the study treatment, MEDI4736 (durvalumab), to the usual therapy of radiation plus cetuximab in patients with head and neck cancer who cannot take the drug cisplatin. Participants in the safety lead-in portion can expect to be in this study for approximately 2.5 years. Participants in the Phase II/III portion can expect to be in the study for up to 32 weeks, and then followed by their study doctor to monitor for side effects every year.

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



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