A Clinical Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of PRAX-944 in Essential Tremor - Part B

Phase 2

Recruiting

• Conditions: Essential Tremor; Neurological - Other neurological disorders

• Registration Number: ACTRN12622000408785
• Lead Sponsor: Praxis Precision Medicines

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-09
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Male or females 18 years of age or older
- Clinical diagnosis of essential tremor (ET)
- Stable dose of 1 tremor medication throughout the clinical trial, or no other tremor medications

Exclusion Criteria

- Clinical evidence of psychogenic tremor
- History of other medical, neurological or psychiatric condition that may explain or
cause tremor
- Prior magnetic resonance-guided focused ultrasound or surgical intervention for ET
such as deep brain stimulation or thalamotomy
- Botulinum toxin injection for ET in the 6 months prior to Screening
- Unwilling or unable to discontinue primidone
- Unwilling or unable to refrain from alcohol 24 hours before and during the clinical trial
visits.
- Any other significant disease, disorder or lab abnormalities that may either put the patient at risk due to participation in the clinical trial, may influence or confound the result of the clinical trial, or affect the patient’s ability to participate in the clinical trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified