Essential Tremor Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Safety, Tolerability and Proof of Concept Study of ST101 for Essential Tremor
This study will look at the ability of ST101 to treat symptoms in subjects with Essential Tremor. This study will also examine the safety and tolerability of the drug. This study is evaluating one dose level of ST101 versus placebo in a cross-over fashion. This means that all patients will receive both ST101 and placebo, but they will receive it in a random (by chance) order.
Essential tremor (ET) is a slowly progressive, chronic neurological disorder characterized by a 4- to 12-Hertz tremor, which can involve the arms, head, voice and lower extremities. Although the hallmark of the disorder is thought to be the kinetic tremor, ET patients usually also manifest a postural tremor as well. Kinetic tremor (tremor with voluntary movements) may interfere with fine motor skills (e.g., writing, eating, drinking from a cup, pouring liquids); and depending upon its severity, may result in significant disability and diminished quality of daily living. Essential tremor represents an area of unmet medical need and this study is designed as a safety, tolerability and proof-of-concept investigation of the ability of ST101 to improve tremor. In this 2-stage study, subjects will be randomly assigned to either ST101 or placebo in Stage 1, and will receive the alternate treatment in Stage 2. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| 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| Withdrawn |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 |