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NCT03101241 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 RCT Study of CX-8998 for Essential Tremor
A Phase 2 study, sponsored by Jazz Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 95
- Enrollment target
NCT03101241: Completed Phase 2 study, sponsored by Jazz Pharmaceuticals.
NCT03101241 is a Phase 2 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 95 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03101241, a Phase 2 study, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 95 participants
- Enrollment target
Study Summary
This is a multicenter, double-blind, placebo-controlled, parallel-group study consisting of a screening period of up to 4 weeks (with the exception of participants on primidone at baseline who will be allowed 6 weeks of screening to allow for safe discontinuation). Screening results from all patients meeting the eligibility requirements will be further assessed by the sponsor medical personnel for final approval of suitability for inclusion in the study. Randomized participants will enter a 4 week double-blind dose-titration treatment period, followed by a 1 week safety follow-up period following the last dose of study medication, and a scheduled follow-up safety telephone call one week later.
Primary Outcome
The Essential Tremor Rating Assessment Scale Performance Subscale (TETRAS-PS) was used to assess the efficacy of CX-8998 in reducing essential tremor as scored by the independent video raters. TETRAS-PS quantifies tremor in the head, face, voice, limbs, and trunk. The overall subscale score ranges from a minimum of 0 to a maximum of 64. A lower score is indicative of improvement and a better outcome.
Interventions
- DRUG Placebo
- DRUG CX-8998
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2017-08-29 |
| Est. Completion | 2018-07-16 |
| Phase | Phase 2 |
What the finished NCT03101241 record still lists
NCT03101241 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03101241 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03101241 about?
NCT03101241 is a clinical study titled "A Phase 2 RCT Study of CX-8998 for Essential Tremor". This is a multicenter, double-blind, placebo-controlled, parallel-group study consisting of a screening period of up to 4 weeks (with the exception of participants on primidone at baseline who will be allowed 6 weeks of screening to allow for safe discontinuation). Screening results from all patient...
What is the current status of trial NCT03101241?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 95 participants. The study started on 2017-08-29. Estimated completion is 2018-07-16.
What interventions are being tested in trial NCT03101241?
The interventions under investigation include: Placebo (DRUG), CX-8998 (DRUG).
Who is sponsoring clinical trial NCT03101241?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03101241's enrollment target sits among peer trials
95 759th of 2000 higher than 1,237 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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