Phase 2
Completed N=20
Multiple-dose,Double-blind,Placebo-controlled Study of Sodium Oxybate in Patients With Essential Tremor
Source: ClinicalTrials.gov NCT00598078 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2012
Primary outcomePrimary: 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
Summary
To determine the relationship between drug plasma levels and safety, tolerability and efficacy in patients with essential tremors after dosing with Sodium oxybate
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 |
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. Informational only — not medical advice.