Essential Tremor Clinical Trial
Official title:
Phase 3, Decentralized, Randomized, Double-Blind, Placebo Controlled, Parallel Design, Randomized Withdrawal, and Long-term Safety Study to Evaluate the Efficacy and Safety of Ulixacaltamide (PRAX-944) in Adults With Essential Tremor
The goal of this clinical study is to compare ulixacaltamide and placebo treatment in essential tremor. The main question it aims to answer is: • Is ulixacaltamide a safe and efficacious treatment for patients with essential tremor? Participants will be asked to participate in one of two clinical studies where they will be treated with either ulixacaltamide or placebo for a period of up to 12 weeks. After the controlled study completion, they will be eligible to participate in a long-term, open-label safety study and be treated with ulixacaltamide.
PRAX-944-321 is a decentralized, Phase 3, multi-study, clinical trial evaluating the safety and efficacy of ulixacaltamide in essential tremor (ET). The study includes 2 separate and simultaneous phase 3 pivotal studies, of which one is a parallel design (PD) and the other a randomized withdrawal (RW), with all participants undergoing one screening process and a long-term safety study (LTSS). This study also includes a separate LTSS study for eligible pivotal study and PRAX-944-222 open label extension (OLE) participants. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT05381688 -
VIM DBS Respiratory Modulation: N-of-1 Trial
|
||
| Recruiting |
NCT05101161 -
Neurofeedback Using Implanted Deep Brain Stimulation Electrodes
|
N/A | |
| Completed |
NCT02277106 -
Evaluate SAGE-547 in Participants With Essential Tremor
|
Phase 2 | |
| Recruiting |
NCT05769933 -
Bridging Gaps in the Neuroimaging Puzzle: New Ways to Image Brain Anatomy and Function in Health and Disease Using Electroencephalography and 7 Tesla Magnetic Resonance Imaging
|
||
| Terminated |
NCT02678429 -
Atlas Predicted DBS Settings in Essential Tremor
|
N/A | |
| Terminated |
NCT02894567 -
Evaluation of Directional Recording and Stimulation Using spiderSTN
|
N/A | |
| Completed |
NCT02523807 -
Tremor Monitoring Device
|
N/A | |
| Active, not recruiting |
NCT02255929 -
Gamma Knife Radiosurgery for Treatment of Essential Tremor
|
N/A | |
| Completed |
NCT01223144 -
Decision-making and Emotion Recognition in Essential Tremor
|
N/A | |
| Completed |
NCT00906412 -
Ventrointermediate Nucleus (VIM DBS) and Working Memory
|
N/A | |
| Recruiting |
NCT05214222 -
Penpulimab Plus Chemotherapy With/Without Anlotinib for Patients With Advanced Esophageal Squamous Cell Carcinoma
|
Phase 2 | |
| Completed |
NCT03051178 -
Wearable Sensor for Responsive DBS for ET
|
N/A | |
| Recruiting |
NCT03795935 -
Relief From Side Effects: Clinical Use of Electrodes With Direction
|
N/A | |
| Not yet recruiting |
NCT06036368 -
Study to Evaluate Safety and Efficacy of Peroneal Transcutaneous NeuroModulation in Subjects With Parkinson's Disease and Essential Tremor
|
N/A | |
| Recruiting |
NCT05897775 -
Coordinated Reset Deep Brain Stimulation for Essential Tremor
|
Phase 1 | |
| Recruiting |
NCT05968976 -
Multicentre RCT of Awake Versus Asleep Tractography Based DBS for ET
|
N/A | |
| Completed |
NCT06314139 -
Tolerability and Efficacy of Continuous Theta-burst Stimulation for Essential Tremor: A Randomized Study.
|
N/A | |
| Recruiting |
NCT04501133 -
Sensory-specific Peripheral Stimulation for Tremor Management
|
N/A | |
| Active, not recruiting |
NCT03560622 -
Functional Neuroimaging Feedback for Focused Ultrasound Thalamotomy
|
N/A | |
| Completed |
NCT00368199 -
Transcranial Duplex Scanning and Single Photon Emission Computer Tomography (SPECT) in Parkinsonian Syndromes
|
N/A |