At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 19 enrolled
Drug / intervention
Sodium Oxybate +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multiple-dose, Double-blind, Placebo-controlled, Crossover Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Sodium Oxybate (Xyrem) in Subjects With Moderate to Severe Essential Tremor
In Brief
A Phase 2 clinical trial evaluating Sodium Oxybate and Placebo for Essential Tremor. Completed, enrolled 19 participants across 1 site.
Detailed Summary
To determine the relationship between drug plasma levels and safety, tolerability and efficacy in patients with essential tremors after dosing with Sodium oxybate
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEssential Tremor
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2007
First PostedJan 2008
Primary CompletionAug 2008
Study CompletionDec 2008
TodayJul 2026
First PostedJan 18, 2008
Enrollment StartDec 1, 2007
Primary CompletionAug 1, 2008
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.5 years ago
Interventions
Sodium Oxybatedrug
Dose 1
Sodium Oxybatedrug
Dose 2
Placeboother
Dose 3