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CompletedNCT04880616Updated Jul 12, 2022

Safety, Efficacy, and Tolerability of NBI-827104 for the Treatment of Essential Tremor

A Phase 2 interventional study of NBI-827104 and Placebo in Essential Tremor, sponsored by Neurocrine Biosciences. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-07-12.

Sponsored by Neurocrine Biosciences · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The main objective of this study is to evaluate the efficacy, safety, and tolerability of NBI-827104 in adults with essential tremor.

02

Conditions studied

  • Essential Tremor

Keywords

  • Movement disorder
  • Tremor syndrome
03

In context

Tremor

257 studies on the registry are indexed under Tremor; 59 are open to participants now.

This study's enrollment of 31 is above the median of 25 across 184 interventional studies indexed under Tremor.

Browse Tremor studies →

Lead sponsor

Neurocrine Biosciences is the lead sponsor of 85 studies on the registry; 16 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 23 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female subjects, 18 to 75 years of age, inclusive at screening.
  2. Body mass index (BMI) between 18 and 35 kg/m², inclusive, at screening.
  3. Diagnosis of Essential Tremor (inclusive of Essential Tremor plus) as defined by the Movement Disorders Society Consensus Criteria for Tremor.
  4. Confirmation of bilateral upper limb action tremor in the absence of overt dystonia, ataxia, or parkinsonism.
  5. History of onset of tremor before 65 years of age.
  6. Tremor Performance score of ≥ 2 on at least 2 of the 6 upper limb manoeuvres (Item 4) on the TETRAS Performance Subscale and a total TETRAS Performance score ≥15 at screening.
  7. All women of childbearing potential and all males must practice effective contraception during the study and be willing and able to continue contraception for at least 90 days after their last dose of study drug.

Exclusion criteria

Exclusion Criteria:

  1. Evidence of any acute (at screening or prior to first dose) or chronic disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator.
  2. Have direct or indirect trauma to the nervous system within 3 months preceding the onset of tremor.
  3. Have known history of other medical or neurological conditions that may cause or explain subject's tremor.
  4. Have had prior magnetic resonance guided focused ultrasound or surgical intervention (e.g., deep brain stimulation, ablative thalamotomy or gamma knife thalamotomy).
  5. Have a history or evidence of clinically significant cardiac conduction abnormality, uncontrolled bradyarrhythmia, heart failure, or long QT syndrome.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    Sequence 1

    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.

    Drug: NBI-827104 · Drug: Placebo

  • Experimental
    Sequence 2

    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.

    Drug: NBI-827104 · Drug: Placebo

Interventions

  • DrugNBI-827104

    Capsules for oral administration

  • DrugPlacebo

    Capsules matching NBI-827104 for oral administration

06

What researchers measure

Primary outcomes

  1. Change from Baseline to Day 28 of Each Treatment Period in Amplitude at Peak Frequency of Postural Tremor

    Time frame: Baseline and Day 28 of each treatment period

Secondary outcomes

  1. Change from Baseline in Essential Tremor Rating Assessment Scale (TETRAS) Performance Score

    Time frame: Baseline up to Day 28 of each treatment period

  2. Change from Baseline in TETRAS Activities of Daily Living (ADL) Score

    Time frame: Baseline up to Day 28 of each treatment period

  3. Clinical Global Impression of Change (CGI-C)

    Time frame: Up to Day 28 of each treatment period

07

Study locations

1 site
  • Neurocrine Clinical Site
    Leiden, CL 2333, Netherlands
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04880616
Lead sponsor
Neurocrine Biosciences
Responsible party
Sponsor
First posted
May 11, 2021
Start date
Apr 20, 2021
Primary completion
May 25, 2022
Completion
Jun 8, 2022
Last update
Jul 12, 2022

Study contacts

Clinical Development Lead
study director · Neurocrine Biosciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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