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EPPIC-Net: Novaremed Painful Diabetic Peripheral Neuropathy ISA
James P. Rathmell, MD
Painful Diabetic Neuropathy
The purpose of this study is to investigate the safety and efficacy of the current hard
gelatin capsule formulation of NRD135S.E1 80 mg once daily in the treatment of PDPN when
administered for 13 weeks. expand
The purpose of this study is to investigate the safety and efficacy of the current hard gelatin capsule formulation of NRD135S.E1 80 mg once daily in the treatment of PDPN when administered for 13 weeks. Type: Interventional Start Date: Sep 2022 |
Trial-Ready Cohort-Down Syndrome (TRC-DS)
University of Southern California
Down Syndrome
Alzheimer Disease
Dementia
The purpose of the Trial-Ready Cohort - Down Syndrome (TRC-DS) is to enroll 120 healthy
adults with Down syndrome (DS), between the ages of 25-55, into a trial ready cohort
(TRC), and up to 450 participants in total including co-enrolled in the Alzheimer
Biomarkers Consortium - Down Syndrome (ABC-DS)... expand
The purpose of the Trial-Ready Cohort - Down Syndrome (TRC-DS) is to enroll 120 healthy adults with Down syndrome (DS), between the ages of 25-55, into a trial ready cohort (TRC), and up to 450 participants in total including co-enrolled in the Alzheimer Biomarkers Consortium - Down Syndrome (ABC-DS) study. Participants enrolled in the TRC-DS will undergo longitudinal cognitive and clinical assessment, genetic and biomarker testing, as well as imaging and biospecimen collection. Using these outcome measures, researchers will analyze the relationships between cognitive measures and biomarkers of Alzheimer's disease (AD) to identify endpoints for AD clinical trials in DS that best reflect disease progression. To learn more about the study and participating sites, visit our study website at: https://www.trcds.org/. TRC-DS is collaborating with the Alzheimer's Disease Biomarker Consortium-Down Syndrome (ABC-DS) to allow study participants to be concurrently enrolled in both ABC-DS and TRC-DS, referred to as "co-enrollment". ABC-DS is a longitudinal, observational research study that is overseen at University of Pittsburgh Coordinating Center. ABC-DS participants who express interest in potentially joining a clinical trial in the future and who meet TRC-DS eligibility criteria, may choose to co-enroll in TRC-DS at an ABC-DS Site. Co-enrolled participants will adhere to the ABC-DS protocol and schedule of activities, but agree to share their data with the TRC-DS team and to receive invitations for future participation in clinical trials. Fore more information on ABC-DS please visit https://www.nia.nih.gov/research/abc-ds or http://abcds.pitt.edu/. Type: Observational Start Date: Jun 2021 |
A Study to Learn About the Safety of BIIB091 and Its Effect on Brain Inflammation When Taken Alone or...
Biogen
Relapsing Forms of Multiple Sclerosis
In this study, researchers will learn more about a study drug called BIIB091 in
participants with MS who may be experiencing relapses. It is a 2-part study.
In Part 1, one set of participants will take either BIIB091 or diroximel fumarate (DRF).
In Part 2, a different set of participants will take... expand
In this study, researchers will learn more about a study drug called BIIB091 in participants with MS who may be experiencing relapses. It is a 2-part study. In Part 1, one set of participants will take either BIIB091 or diroximel fumarate (DRF). In Part 2, a different set of participants will take either a combination of BIIB091 and DRF or DRF alone. The goal of the study is to learn more about the safety of BIIB091 and to compare the effects of the study drug when taken alone or together with DRF. The main question researchers are trying to answer are: - How many participants have new or worsening medical problems (adverse events) after taking BIIB091 or DRF? - How many new areas of inflammation occur in the brain after treatment with BIIB091 and DRF? Researchers will use magnetic resonance imaging (MRI) scans to compare images of the brain before and after treatment. They will also explore the effect of BIIB091 and DRF on the heart using electrocardiograms (ECGs). The study will be done as follows: - After screening, participants who joined Part 1 will be randomly assigned to receive either a high or low dose of BIIB091, or the standard dose of DRF. - The results of Part 1 will be used to choose the best dose of BIIB091 to use in Part 2. - Participants who join Part 2 will be randomly assigned to receive either a standard dose of DRF, a combo of BIIB091 and the standard dose of DRF, or a combo of BIIB91 with a low dose of DRF. - Neither the researchers nor the participants will know which drug or dose the participants will receive in either part of the study. - The treatment period will last 48 weeks in each part of the study. Participants will take the drugs by mouth 2 times a day. - Each part will also have a follow-up safety period that lasts up to 2 weeks. - In total, participants in each part will have 20 study visits, or more if they have a relapse. The total study duration for participants will be up to 54 weeks. Type: Interventional Start Date: Jul 2023 |
More and Less Social Comprehension
University of Kansas Medical Center
Autism Spectrum Disorder
The goal of this early Phase 1 clinical trial is to assess if the social content of a
story impacts autistic children's listening comprehension of stories. The main questions
this study aims to answer are:
- Does removing social content from a story improve listening comprehension in
autistic... expand
The goal of this early Phase 1 clinical trial is to assess if the social content of a story impacts autistic children's listening comprehension of stories. The main questions this study aims to answer are: - Does removing social content from a story improve listening comprehension in autistic children? - Does listening comprehension of more social versus less social stories differentially predict performance on a standardized reading comprehension measure? Participants will listen to more social and less social stories while viewing accompanying pictures and answer comprehension questions about the stories and complete a standardized assessment of reading comprehension. In addition, participants complete measures of their nonverbal cognition, hearing status, autism severity, language abilities, and social communication abilities to help characterize individual differences in participants. Type: Interventional Start Date: Jul 2023 |
EPPIC-Net: Platform Protocol to Assess Treatments for Painful Diabetic Peripheral Neuropathy
James P. Rathmell, MD
Painful Diabetic Neuropathy
This is a Platform Protocol to perform Phase II clinical trials in The Early Phase Pain
Investigation Clinical Network (EPPIC-Net), under The Helping to End Addiction
Long-termSM Initiative, or NIH HEAL InitiativeSM, related to the treatment of Painful
Diabetic Peripheral Neuropathy (PDPN) in a platform... expand
This is a Platform Protocol to perform Phase II clinical trials in The Early Phase Pain Investigation Clinical Network (EPPIC-Net), under The Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM, related to the treatment of Painful Diabetic Peripheral Neuropathy (PDPN) in a platform setting to test multiple assets under a single protocol. Type: Interventional Start Date: Sep 2022 |
A Study of TCD601 in de Novo Renal Transplant Recipients
ITB-Med LLC
Renal Transplantation
The purpose of this study is to evaluate the safety and efficacy of TCD601 in combination
with Belatacept when compared to standard of care immunosuppression therapy in de novo
renal transplant patients. expand
The purpose of this study is to evaluate the safety and efficacy of TCD601 in combination with Belatacept when compared to standard of care immunosuppression therapy in de novo renal transplant patients. Type: Interventional Start Date: Dec 2023 |
American Lung Association (ALA) Lung Health Cohort
Johns Hopkins University
Lung Diseases
The ALA-LHC is a longitudinal, multi-center cohort study that will enroll approximately
4,000 young adults between the ages of 25-35 who do not have severe lung disease. The
overarching objective of the ALA-LHC is to establish a national cohort of young adults
for the purpose of defining lung health... expand
The ALA-LHC is a longitudinal, multi-center cohort study that will enroll approximately 4,000 young adults between the ages of 25-35 who do not have severe lung disease. The overarching objective of the ALA-LHC is to establish a national cohort of young adults for the purpose of defining lung health and developing targets to intercept chronic lung disease at its earliest stages. Type: Observational Start Date: Oct 2021 |
AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants...
Eisai Inc.
Preclinical Alzheimer's Disease
Early Preclinical Alzheimer's Disease
The primary purpose of this study is to determine whether treatment with lecanemab is
superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive
Composite 5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether
treatment with lecanemab is superior to placebo... expand
The primary purpose of this study is to determine whether treatment with lecanemab is superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite 5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether treatment with lecanemab is superior to placebo in reducing brain amyloid accumulation as measured by amyloid positron emission tomography (PET) at 216 weeks of treatment (A3 Trial). This study will also evaluate the long-term safety and tolerability of lecanemab in participants enrolled in the Extension Phase. Type: Interventional Start Date: Jul 2020 |
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