Acamprosate and Methazolamide for Essential Tremor: a Randomized Clinical Trial

LeWitt02

This is an investigator initiated study is designed to evaluate the anti-tremor benefits of two marketed medications, methazolamide and acamprosate in subjects with a diagnosis of essential tremor (ET).

2016-03-01

2017-06-01

2017-12-01

Withdrawn

Early phase I

Inclusion Criteria: 1. bilateral, largely symmetric postural or kinetic tremor involving hands and forearms that is visible and persistent. Subjects need to meet a FTMRS \[1\] Part A motor score of at least 2 ("Moderate amplitude, 0.5-1 cm, may be intermittent") in the dominant upper limb for action or postural tremor (or both). 2. additional tremor (head, voice, or lower extremity) may also be present but in the absence of abnormal posturing so as to suggest the diagnosis of dystonia. Exclusion Criteria: 1. other abnormal neurologic signs 2. the presence of known causes of enhanced physiologic tremor, including current or recent exposure to drugs known to cause or exacerbate tremor, or the presence of a drug -withdrawal state 3. historical or clinical evidence of psychogenic tremor 4. convincing evidence of sudden onset or other evidence of stepwise deterioration 5. primary orthostatic tremor 6. isolated position-specific or task-specific tremors, including occupational tremors and primary writing tremor 7. tremor possibly or probably due to other neurological disorders (such as Parkinson's disease, cerebellar degeneration, and hyperthyroidism) 8. prior brain surgery (including deep brain stimulation of Gamma Knife treatment) for thalamotomy 9. known allergy to the study medications 10. clinically significant liver, kidney, or cardiac abnormalities

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

2024-03-15