Essential TremorPhase 2NCT00598078
Multiple-dose,Double-blind,Placebo-controlled Study of Sodium Oxybate in Patients With Essential Tremor
A Phase 2 study testing Sodium Oxybate in people with Essential Tremor, run by Jazz Pharmaceuticals at 1 site in United States.
Trial summary
To determine the relationship between drug plasma levels and safety, tolerability and efficacy in patients with essential tremors after dosing with Sodium oxybate Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Essential Tremor
- What is being tested?
- Sodium Oxybate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Dec 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Quest Research Institiute
Bingham Farms, Michigan, 48025
About this study
Official title: 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
To determine the relationship between drug plasma levels and safety, tolerability and efficacy in patients with essential tremors after dosing with Sodium oxybate
- Conditions
- Essential Tremor
- Being tested
- Sodium Oxybate, Placebo
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium OxybateDrug
Dose 1
Sodium OxybateDrug
Dose 2
PlaceboOther
Dose 3
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Sodium Oxybate |
| 2 | Experimental | Not described Receives: Drug: Sodium Oxybate |
| 3 | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified FTM(Fahn-Tolosa-Marin) Essentials Tremor Rating Scale, Sum of All Essential Rating Tremor Scales Including Voice Tremor
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 ranges from 0 (no tremor) to 72 points (higher amplitude/more tremors).
Measured: Hour 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionAug 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aaron Ellenbogen, DO, Principal investigator, Quest Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00598078
- Sponsor's protocol ID
- 06-015
- Status last verified
- Dec 2011
- First submitted
- 9 Jan 2008
- Last updated
- 23 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00598078
- Acronym / sponsor ID
- 06-015
- Conditions
- Essential Tremor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 18 Jan 2008 (estimated)
- Results
- Posted 23 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the relationship between drug plasma levels and safety, tolerability and efficacy in patients with essential tremors after dosing with Sodium oxybate
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Sodium Oxybate |
| 2 | Experimental | Drug: Sodium Oxybate |
| 3 | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium OxybateDose 1 | Drug | 1 |
| Sodium OxybateDose 2 | Drug | 2 |
| PlaceboDose 3 | Other | 3 |
Primary outcome
Modified FTM(Fahn-Tolosa-Marin) Essentials Tremor Rating Scale, Sum of All Essential Rating Tremor Scales Including Voice Tremor
Time frame: Hour 1
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 ranges from 0 (no tremor) to 72 points (higher amplitude/more tremors).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron Ellenbogen, DO principal investigator
Quest Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium Oxybate in people with Essential Tremor, run by Jazz Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified FTM(Fahn-Tolosa-Marin) Essentials Tremor Rating Scale, Sum of All Essential Rating Tremor Scales Including Voice Tremor (time frame: Hour 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2012.