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To determine the relationship between drug plasma levels and safety, tolerability and efficacy in patients with essential tremors after dosing with Sodium oxybate
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Oxybate | Drug | Dose 1 |
| |
| Sodium Oxybate |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Hour 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aaron Ellenbogen, DO | Quest Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quest Research Institiute | Bingham Farms | Michigan | 48025 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Regimen A, Then B, Then C | Day 1: Sodium Oxybate 0.75g at ~8am, Sodium Oxybate 0.75g at ~10am, placebo at ~12pm; Day 2:Sodium Oxybate 1.5g at ~8am, placebo at ~10am, Sodium Oxybate 1.5g at ~12pm; Day 3:Placebo at ~8am, ~10am, and ~12pm |
| FG001 | Regimen A, Then C, Then B | Day 1: Sodium Oxybate 0.75g at ~8am, Sodium Oxybate 0.75g at ~10am, placebo at ~12pm; Day 2: Placebo at ~8am, ~10am, and ~12pm; Day 3: Sodium Oxybate 1.5g at ~8am, placebo at ~10am, Sodium Oxybate 1.5g at ~12pm; |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (Day 1) |
| |||||||||||||
| Period 2 (Day 2) |
| |||||||||||||
| Period 3 (Day 3) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All treated study participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Least Squares Mean | 90% Confidence Interval | Points | Hour 1 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sodium Oxybate 1.5 Grams (A) | Sodium Oxybate 0.75g at ~8am, Sodium Oxybate 0.75g at ~10am, placebo at ~12pm (Day 1 only) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grace Wang, MD Director Clinical Development and Medical Monitor | Jazz Pharmaceuticals | 650-496-3777 |
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| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D012978 | Sodium Oxybate |
| ID | Term |
|---|---|
| D006885 | Hydroxybutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Drug |
Dose 2 |
|
| Placebo | Other | Dose 3 |
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Sodium Oxybate 3 Grams (B) | Sodium Oxybate 1.5g at ~8am, placebo at ~10am, Sodium Oxybate 1.5g at ~12pm (Day 2 or 3) |
| OG002 | Placebo (C) | Placebo at ~8am, ~10am, and ~12pm (Day 2 or 3) |
|
|
|
| 0 |
| 20 |
| 5 |
| 20 |
| EG001 | Sodium Oxybate 3 Grams (B) | Sodium Oxybate 1.5g at ~8am, placebo at ~10am, Sodium Oxybate 1.5g at ~12pm (Day 2 or 3) | 0 | 20 | 12 | 20 |
| EG002 | Placebo (C) | Placebo at ~8am, ~10am, and ~12pm (Day 2 or 3) | 0 | 19 | 1 | 19 |
| Headache | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Disturbance in Attention | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Feeling Drunk | General disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Chest Pain | General disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Feeling Abnormal | General disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Euphoric Mood | Psychiatric disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Paranoia | Psychiatric disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Tearfulness | Psychiatric disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Lacrimation Increased | Eye disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
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| D009930 |
| Organic Chemicals |
| D006880 | Hydroxy Acids |