Clinical trials: Upper Extremity Impairments
Parkinson Disease
Modulation of GABA-A Receptors in Parkinson Disease-Transdermal Flumazenil Arm
The arm of this study evaluates possible GABA-A receptor target engagement effects of the FDA-approved medication, transdermal flumazenil (added 4/2020, replaced clarithromycin), in the setting of Parkinson's disease.
- Trial name
- GABA-A (NCT03440112)
- Testing
- Clarithromycin (Not used as of 4/2020), Transdermal flumazenil (Added 4/2020)
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Nicolaas Bohnen, MD, PhD
Traumatic Brain Injury, Stroke
Myoelectric Upper Limb Orthosis Use by Persons With TBI and Stroke
The objective of this study was to document longitudinal outcomes in persons with traumatic brain injury (TBI) or stroke using the myoelectric upper limb orthosis with powered elbow and grasp in conjunction with motor…
- Trial name
- NCT03215771
- Testing
- MyoPro Motion-G, Motor Learning-Based Therapy
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Northwestern University
Stroke
Targeted High-definition Transcranial Direct Current Stimulation (HD-tDCS) for Reducing Post-stroke Movement Impairments
Stroke is the leading cause of serious, long-term disability. The emergence of abnormal muscle synergies following a stroke presents a major limitation to the recovery of independent function.
- Trial name
- NCT05174949
- Testing
- Transcranial direct current stimulation (high-definition)
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- University of Oklahoma
Macular Edema, Retinal Vein Occlusion
A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO)
This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept, in participants with macular edema due to treatment-naïve branch (BRVO) or central retinal vein occlusion (CRVO).
- Trial name
- BEACON (NCT04592419)
- Testing
- KSI-301, Aflibercept
- Where
- 141 sites in United States, Czechia and 10 more
- Volunteers
- 568 people
- Sponsor
- Kodiak Sciences Inc
Diabetic Macular Edema
To Compare Brolucizumab to Aflibercept in Chinese Patients With Visual Impairment Due to Diabetic Macular Edema
The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of Chinese patients with visual impairment due to Diabetic Macular Edema.
- Trial name
- KINGLET (NCT04058067)
- Testing
- Brolucizumab, Aflibercept
- Where
- 24 sites in China
- Volunteers
- 266 people
- Sponsor
- Novartis Pharmaceuticals
Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease
Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease
The PATHFINDER Registry is a prospective, non-randomized, single arm, multicenter observational study. This pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term)…
- Conditions
- Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease, PAD
- Trial name
- PATHFINDER (NCT04229563)
- Testing
- AURYON Atherectomy System
- Where
- 10 sites in United States
- Volunteers
- 102 people
- Sponsor
- Angiodynamics, Inc.
Solid Tumors, Hematologic Malignancies
Study of the Pharmacokinetics and Safety of Carfilzomib in Patients With Advanced Malignancies and Hepatic Impairment
The purpose of this study is to compare the safety and efficacy of carfilzomib, including measuring the amount of the study drug in the blood at certain times following dosing.
- Conditions
- Solid Tumors, Hematologic Malignancies, Hepatic Impairment
- Trial name
- NCT01949545
- Testing
- Carfilzomib
- Where
- 11 sites in United States, France and 2 more
- Volunteers
- 46 people
- Sponsor
- Amgen
Type 2 Diabetes Mellitus, Chronic Kidney Disease Stage 3
Safety and Efficacy Study of Sotagliflozin on Glucose Control in Participants With Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control
Primary Objective: To demonstrate the superiority of Sotagliflozin 200 milligrams (mg) and Sotagliflozin 400 mg versus placebo on HbA1c reduction at 26 Weeks in participants with Type 2 diabetes who have inadequate glycemic…
- Trial name
- SOTA-CKD3 (NCT03242252)
- Testing
- Sotagliflozin
- Where
- 170 sites in United States, Argentina and 14 more
- Volunteers
- 787 people
- Sponsor
- Lexicon Pharmaceuticals
Diabetic Macular Edema
A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)
This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept in participants with treatment-naïve DME.
- Trial name
- GLIMMER (NCT04603937)
- Testing
- KSI-301, Aflibercept
- Where
- 72 sites in United States, Czechia and 6 more
- Volunteers
- 459 people
- Sponsor
- Kodiak Sciences Inc
Macular Edema, Central Retinal Vein Occlusion
Ranibizumab Intravitreal Injections in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion
The present study provided additional efficacy and safety data for 0.5-mg ranibizumab using as needed (PRN) dosing over 24 months in patients with visual impairment due to macular edema secondary to Central Retinal Vein Occlusion…
- Trial name
- CRYSTAL (NCT01535261)
- Testing
- Ranibizumab 0.5 mg/0.05 ml
- Where
- 78 sites in Australia, Austria and 16 more
- Volunteers
- 357 people
- Sponsor
- Novartis Pharmaceuticals
Idiopathic Pulmonary Fibrosis
Effect of Nintedanib on Biomarkers of Extracellular Matrix Turnover in Patients With Idiopathic Pulmonary Fibrosis and Limited Forced Vital Capacity Impairment
Identifying biomarkers to predict the clinical course and benefits of therapy early in the course of the disease remains one of the most urgent and relevant challenges to improve overall patient management, to prevent treatment…
- Trial name
- NCT02788474
- Testing
- nintedanib
- Where
- 86 sites in United States, Australia and 11 more
- Volunteers
- 347 people
- Sponsor
- Boehringer Ingelheim
Branch Retinal Vein Occlusion
Efficacy and Safety of Ranibizumab With or Without Laser in Comparison to Laser in Branch Retinal Vein Occlusion
This study will generate comparative data for 0.5-mg ranibizumab using PRN dosing administered with or without adjunctive laser treatment versus laser photocoagulation (the current standard of care) up to Month 6 in patients with…
- Trial name
- BRIGHTER (NCT01599650)
- Testing
- Ranibizumab, Laser
- Where
- 82 sites in Australia, Canada and 15 more
- Volunteers
- 455 people
- Sponsor
- Novartis Pharmaceuticals
Mild Cognitive Impairment (MCI), Alzheimer Disease
A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)
The main purpose of this study is to compare donanemab to aducanumab on brain amyloid plaque clearance in participants with early symptomatic Alzheimer's Disease (AD).
- Trial name
- NCT05108922
- Testing
- Donanemab, Aducanumab
- Where
- 31 sites in United States
- Volunteers
- 148 people
- Sponsor
- Eli Lilly and Company
Type 2 Diabetes Mellitus, Chronic Kidney Disease Stage 4
A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control
Primary Objective: To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (HbA1c) reduction at Week 26 in participants with Type 2 diabetes who have inadequate glycemic…
- Trial name
- SOTA-CKD4 (NCT03242018)
- Testing
- Sotagliflozin
- Where
- 106 sites in United States, Argentina and 13 more
- Volunteers
- 277 people
- Sponsor
- Lexicon Pharmaceuticals
Diabetic Macular Edema
A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)
This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept in participants with treatment-naïve DME.
- Trial name
- GLEAM (NCT04611152)
- Testing
- KSI-301, Aflibercept
- Where
- 75 sites in United States, Germany and 6 more
- Volunteers
- 460 people
- Sponsor
- Kodiak Sciences Inc
Central Retinal Vein Occlusion
Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion
The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of patients with macular edema (ME) secondary to central retinal vein occlusion (CRVO).
- Trial name
- RAVEN (NCT03810313)
- Testing
- Brolucizumab 6 mg, Aflibercept 2 mg
- Where
- 120 sites in United States, Australia and 18 more
- Volunteers
- 493 people
- Sponsor
- Novartis Pharmaceuticals
Hunter Syndrome
Study of Intrathecal Idursulfase-IT Administered in Conjunction With Elaprase® in Pediatric Patients With Hunter Syndrome and Early Cognitive Impairment
Study HGT-HIT-094 is a multicenter study designed to determine the effect on clinical parameters of neurodevelopmental status of monthly IT administration of idursulfase-IT 10 mg for 12 months in pediatric patients with Hunter…
- Trial name
- AIM-IT (NCT02055118)
- Testing
- idursulfase-IT, No IT treatment
- Where
- 9 sites in United States, Australia and 5 more
- Volunteers
- 58 people
- Sponsor
- Shire
Parkinson Disease
Modulation of GABA-A Receptors in Parkinson Disease-Flumazenil Arm
This arm is a positron emission tomography (PET) biomechanistic GABA-A receptor target engagement study that includes detailed clinical and motor assessments before and after the i.v.
- Trial name
- NCT03462641
- Testing
- Flumazenil
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- University of Michigan
Walking Impairment, Multiple Sclerosis
Safety and Efficacy of ADS-5102 in Multiple Sclerosis Patients With Walking Impairment
This study assessed the efficacy and safety of ADS-5102 (at daily doses of 137 mg or 274 mg) compared with placebo in MS patients with walking impairment.
- Trial name
- NCT03436199
- Testing
- ADS-5102, 137 mg, ADS-5102, 274 mg
- Where
- 84 sites in United States, Canada
- Volunteers
- 558 people
- Sponsor
- Adamas Pharmaceuticals, Inc.
Diabetic Macular Edema
A Study of the Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema
This was a Phase III, randomized, double-masked, multi-center, active-controlled, two-arm study designed to evaluate the efficacy and safety of brolucizumab 6 mg compared to the active control, aflibercept 2 mg used per…
- Trial name
- KITE (NCT03481660)
- Testing
- Brolucizumab, Aflibercept
- Where
- 78 sites in Belgium, Bulgaria and 21 more
- Volunteers
- 360 people
- Sponsor
- Novartis Pharmaceuticals