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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-006012-24 | EudraCT Number |
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The main objective of this study is to evaluate the efficacy, safety, and tolerability of NBI-827104 in adults with essential tremor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | In treatment period 1 participants will receive increasing doses of NBI-827104 for 28 days. After a 14-day washout period, participants will receive matching placebo for 28 days in treatment period 2. |
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| Sequence 2 | Experimental | In treatment period 1 participants will receive matching placebo for 28 days. After a 14-day washout period, participants will receive increasing doses of NBI-827104 for 28 days in treatment period 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBI-827104 | Drug | Capsules for oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline to Day 28 of Each Treatment Period in Amplitude at Peak Frequency of Postural Tremor | Baseline and Day 28 of each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Essential Tremor Rating Assessment Scale (TETRAS) Performance Score | Baseline up to Day 28 of each treatment period | |
| Change from Baseline in TETRAS Activities of Daily Living (ADL) Score | Baseline up to Day 28 of each treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Lead | Neurocrine Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurocrine Clinical Site | Leiden | CL | 2333 | Netherlands |
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| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| D009069 | Movement Disorders |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Placebo |
| Drug |
Capsules matching NBI-827104 for oral administration |
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| Clinical Global Impression of Change (CGI-C) | Up to Day 28 of each treatment period |