Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This will be a multi-site, prospective, double-blind, randomized, placebo-controlled, crossover trial conducted over 6 months to assess the effectiveness and safety of PGB to treat symptoms of ET.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Pregabalin |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | Gradually titrated dose ranging from 75mg po bid to 225mg po bid. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Fahn-Tolosa-Marin Essential Tremor Rating Scale (FTM) total score | 61 days |
| Measure | Description | Time Frame |
|---|---|---|
| Writing tablet recordings of tremor amplitude | 61 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Theresa A Zesiewicz, MD | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University of South Florida |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 6, 2018 | |
| Reset | May 1, 2018 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 6, 2018 | May 1, 2018 |
| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| D014202 | Tremor |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020820 | Dyskinesias |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Placebo capsules which are identical in packaging, appearance and dosing as the active capsules. |
|
| Tampa |
| Florida |
| 33612 |
| United States |
| Emory Univ. School of Medicine | Atlanta | Georgia | 30329 | United States |
| Medical College of Georgia | Augusta | Georgia | 30912 | United States |
| Southern Illinois U. School of Medicine | Springfield | Illinois | 62794 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| University of Tennessee Health Science Center | Memphis | Tennessee | 38163 | United States |
| Vanderbilt | Nashville | Tennessee | 37232 | United States |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |