Phase 2
N=20
Multiple-dose,Double-blind,Placebo-controlled Study of Sodium Oxybate in Patients With Essential Tremor
Essential Tremor
Bottom Line
View on ClinicalTrials.gov: NCT00598078 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2012
Primary outcome: Primary: Modified FTM(Fahn-Tolosa-Marin) Essentials Tremor Rating Scale, Sum of All Essential Rating Tremor Scales Including Voice Tremor — 13.4; 10.8; 13.0 Points — p=0.013
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sodium Oxybate (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Jazz Pharmaceuticals
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Modified FTM(Fahn-Tolosa-Marin) Essentials Tremor Rating Scale, Sum of All Essential Rating Tremor Scales Including Voice Tremor |
13.4; 10.8; 13.0 | 0.013 sig |
Summary
To determine the relationship between drug plasma levels and safety, tolerability and efficacy in patients with essential tremors after dosing with Sodium oxybate
Eligibility Criteria
Inclusion Criteria
- Diagnosis of moderate or severe classic essential tremor (bilateral, largely symmetric postural or kinetic tremor involving hands and forearms.
- Willingness to abstain from ethanol and caffeine intake for at least 48 hours prior to Days 1 and 4 and on inpatient days
Exclusion Criteria
- Subjects with a clinically significant unstable medical abnormality, chronic disease or history or presence of significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, psychiatric, or metabolic disease or any other abnormality
- Subjects who are on sodium-restricted diets
- Subjects with a known history of sleep apnea
Data sourced from ClinicalTrials.gov (NCT00598078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.