Essential Tremor Clinical Trial
Official title:
Phase II Efficacy and Safety of Taro Pharmaceuticals' Pro-Drug T2000 (1,3-Dimethoxymethyl-5,5-Diphenyl-Barbituric Acid) In Patients With Essential Tremor: A Randomized, Double-Blind, Placebo-Controlled, Sequential Dose Escalation Study
This study will evaluate the safety and efficacy of T2000 when used to treat patients with
moderate to severe essential tremor over a 20 week period.
Essential tremor (ET) is a common form of involuntary shaking not related to Parkinson's
disease. The medications that are currently used to treat ET work in a small proportion of
patients and provide only partial improvement in symptoms. Use of these current medications
is also limited by side-effects in many patients.
T2000 is a medication currently under development for the treatment of essential tremor.
Although T2000 is a new medication, it belongs to a class of medications that has been used
for many years for the treatment of a variety of medical conditions. In previous studies,
T2000 appeared to be effective in controlling symptoms of ET and some patients with severe
ET had major improvements in tremor. T2000 was well tolerated for periods up to 20 days and
the minimal side-effects seen were those that would be expected for medications in this
class.
The current study will evaluate the safety and efficacy of T2000 in patients with moderate
to severe essential tremor. Patients will receive doses of T2000 beginning at 600 mg a day,
followed by 800 mg a day and up to 1000 mg a day. The total duration of treatment will be 20
weeks. Patient's tremor and neurological examination will be monitored throughout the study.
The response to T2000 will be determined by comparing the severity of tremor while patients
are receiving T2000 compared to the tremor observed without active medication.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), 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Withdrawn |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 |
NCT02894567 -
Evaluation of Directional Recording and Stimulation Using spiderSTN
|
N/A | |
Terminated |
NCT02678429 -
Atlas Predicted DBS Settings in Essential Tremor
|
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 |