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NBI-827104 in essential tremor
NCT04880616Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2021
- Primary completion
- May 2022
- Countries
- 1
- Sponsor
- Neurocrine Biosciences
- Modality
- Small Molecules
- Drugs
- NBI-827104
- Conditions
- essential tremor (ET)
01
Overview
Phase 2, randomised, double-blind trial of NBI-827104 in essential tremor (ET) (2 arms), sponsored by Neurocrine Biosciences. Primary endpoint: Change from Baseline to Day 28 of Each Treatment Period in Amplitude at Peak Frequency of Postural Tremor. Started Apr 2021; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Sequence 1
NBI-827104 -> Washout -> Placebo
Sequence 2
Placebo -> Washout -> NBI-827104
03
Who it enrols
Adults 18-75 with a diagnosis of Essential Tremor (MDS criteria), BMI 18-35, and bilateral upper limb action tremor. Excludes patients with parkinsonism, dystonia, or prior surgical interventions for tremor.
04
Endpoints
Primary
Change from Baseline to Day 28 of Each Treatment Period in Amplitude at Peak Frequency of Postural Tremor
Secondary
Change from Baseline in Essential Tremor Rating Assessment Scale (TETRAS) Performance Score
Change from Baseline in TETRAS Activities of Daily Living (ADL) Score
Clinical Global Impression of Change
05
Results
Not all primary endpoints met
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