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

A Phase 2 Clinical Trial Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of PRAX-944 in Adults with Essential Tremor

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619001052123

Enrollment

Registered

2019-07-26

Start date

2020-03-03

Completion date

Unknown

Last updated

2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is Part A of a 2-part, Phase 2, Clinical Trial Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of PRAX-944 in Adults with Essential Tremor. Each participant will complete 3 study periods: Screening, Treatment Period (21 or 28 days) and Safety Follow-up.

Interventions

PRAX-944 20mg orally once a day for 7 days and 40mg orally once a day for 7 days (total of 14 days consecutively) Study drug adherence will be monitored by a compliance application and verified by unused product return.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

- Male or females between the ages of 18 and 75 years - 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.

Outcome results