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| ID | Type | Description | Link |
|---|---|---|---|
| 11-01864 |
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The purpose of this study is to determine if vigabatrin, an unusual anti-seizure medication, will diminish the Tourette Disorder outbursts in young adults whose symptoms have persisted into adulthood and have not responded to usual treatment.
The aims of this study are to 1) explore proof of concept that CPP-109 will reduce tics, and 2) to obtain systematic data regarding dosing, safety and tolerability of CPP-109 in adults with treatment refractory TD. We will obtain preliminary data on estimate of effect size for tics using Cohen's d, calculating the difference between the two means (baseline and endpoint scores on the YGTSS), divided by the standard deviation of the difference.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vigabatrin | Experimental | 3 tablets, bid for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vigabatrin | Drug | 3 tablets, bid for 8 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Global Severity Score on the Y-GTSS | The Global Severity score is the sum of the Total Tic score and the TD Impairment score. It is rated by the Investigator on the Yale Global Tic Severity Score ( Y-GTSS, a widely accepted measure of drug efficacy in TD. Scale from 0- 100. Higher score indicates more impairment. | weekly from baseline to end of study (10weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan D Brodie, PhD,MD | NYU School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tics and Tourette's Clinical and Research Program | New York | New York | 10029 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vigabatrin | 3 tablets, bid for 8 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vigabatrin | 3 tablets, bid for 8 weeks |
| 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 | Global Severity Score on the Y-GTSS | The Global Severity score is the sum of the Total Tic score and the TD Impairment score. It is rated by the Investigator on the Yale Global Tic Severity Score ( Y-GTSS, a widely accepted measure of drug efficacy in TD. Scale from 0- 100. Higher score indicates more impairment. | Posted | Mean | Full Range | units on a scale | weekly from baseline to end of study (10weeks) |
|
|
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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 | Vigabatrin | 3 tablets, bid for 8 weeks | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Barbara J. Coffey | Icahn School of Medicine at Mount Sinai | 212-659-1663 | Barbara.coffey@mssm.edu |
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| ID | Term |
|---|---|
| D005879 | Tourette Syndrome |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D020888 | Vigabatrin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| YGTSS (total tic) | Yale Global Tic Severity Scale (YGTSS) - The Total Tic Score is a summation of the Total Motor Tic (0 -25) and Total Phonic Tic (0-25) Scores, full range 0 (No impairment) to 50 (Severe impairment) | Mean | Standard Deviation | total tics |
|
|
| 4 |
| 0 |
| 4 |
| 4 |
| 4 |
| Appetite Increase | General disorders |
|
| Sleep Difficulties | General disorders |
|
| Increase in OCD symptoms | Nervous system disorders |
|
| Dry mouth | General disorders |
|
| Mood swings | Nervous system disorders |
|
| Memory impairment | Nervous system disorders |
|
| Daytime tiredness | General disorders |
|
| Vivid dreams | General disorders |
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| Possible weight gain | General disorders |
|
| Blurry Vision | Eye disorders |
|
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| D013981 | Tic Disorders |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |