NCT06087276Phase 3Active not recruiting

Essential 3 - Decentralized, Phase 3 Study Evaluating the Safety and Efficacy of Ulixacaltamide in Essential Tremor (ET)

Study sponsor: Praxis Precision Medicines

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

Primary completion2025-10-10Actual
Enrollment · participants1000Estimated
Source updated2026-07-16Last update listed in the registry record
Version history

Changes to this trial

Last 12 months
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· 3 fields changed

Completion date type

Recorded edit
− Previous value

Estimated

+ Updated value

Actual

Primary completion date

Recorded edit
− Previous value

2025-09

+ Updated value

2025-10-10

Recruitment status

Recorded edit
− Previous value

Enrolling by invitation

+ Updated value

Active not recruiting

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· 4 fields changed

Primary outcomes · main study measures

Text edit · unverified significance
− Previous value

measure: Parallel Design: Change from Baseline (CFB) to Week 12 (Day 84) on mADL11; measure: Randomized Withdrawal: The proportion of participants that maintain response, as defined by change in mADL11 score, following randomized withdrawal; measure: Long-term Safety Study: Number of participants with Adverse Events (AE) and their severity.

+ Updated value

measure: Parallel Design: Change from Baseline (CFB) to Week 8 (Day 56) on mADL11 score; measure: Randomized Withdrawal: The proportion of participants that maintain response, as defined by change in mADL11 score, following randomized withdrawal; measure: Long-term Safety Study: Number of participants with Adverse Events (AE) and their severity.

The saved outcome text may be shortened. Check the source for full wording.

Enrollment · participant count

Recorded edit
− Previous value

count: 600; type: ESTIMATED

+ Updated value

count: 1000; type: ESTIMATED

Primary completion date

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− Previous value

2024-09

+ Updated value

2025-09

Recruitment status

Recorded edit
− Previous value

Recruiting

+ Updated value

Enrolling by invitation

Check registry source