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NCT00598078 · ClinicalTrials.gov registry record · Phase 2

Multiple-dose,Double-blind,Placebo-controlled Study of Sodium Oxybate in Patients With Essential Tremor

A Phase 2 study, sponsored by Jazz Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
19
Enrollment target

NCT00598078: Completed Phase 2 study, sponsored by Jazz Pharmaceuticals.

NCT00598078 is a Phase 2 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00598078, a Phase 2 study, has completed, sponsored by Jazz Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
19 participants
Enrollment target

Study Summary

To determine the relationship between drug plasma levels and safety, tolerability and efficacy in patients with essential tremors after dosing with Sodium oxybate

Primary Outcome

The modified FTM sum of all essential rating tremor scales including voice tremor includes: the tremor rating taken for the left \& right hands individually at rest, with posture (arms outstretched), with action (finger to nose). It also includes an evaluation of voice with scores for AAA \& EEE sounds, an action evaluation of left \& right hands pouring, bringing liquids to mouth, drawing large \& small spirals. Scores for indiviuals items range from 0 (no tremor) to 4 (severe tremor). The sum

Interventions

  • OTHER Placebo
  • DRUG Sodium Oxybate

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2007-12
Est. Completion 2008-12
Phase Phase 2
Jazz Pharmaceuticals

128 total trials

What the finished NCT00598078 record still lists

NCT00598078 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00598078 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00598078 about?

NCT00598078 is a clinical study titled "Multiple-dose,Double-blind,Placebo-controlled Study of Sodium Oxybate in Patients With Essential Tremor". To determine the relationship between drug plasma levels and safety, tolerability and efficacy in patients with essential tremors after dosing with Sodium oxybate

What is the current status of trial NCT00598078?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2007-12. Estimated completion is 2008-12.

What interventions are being tested in trial NCT00598078?

The interventions under investigation include: Placebo (OTHER), Sodium Oxybate (DRUG).

Who is sponsoring clinical trial NCT00598078?

This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00598078's enrollment target sits among peer trials

19 1894th of 2000 higher than 103 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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Source: ClinicalTrials.gov NCT00598078, the US trial registry maintained by the National Library of Medicine. NCT00598078 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.