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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04880616
Recruitment Status : Recruiting
First Posted : May 11, 2021
Last Update Posted : April 14, 2022
Sponsor:
Information provided by (Responsible Party):
Neurocrine Biosciences

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

Condition or disease Intervention/treatment Phase
Essential Tremor Drug: NBI-827104 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of NBI-827104 in Subjects With Essential Tremor
Actual Study Start Date : April 20, 2021
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
Capsules for oral administration

Drug: Placebo
Capsules matching NBI-827104 for oral administration
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
Capsules for oral administration

Drug: Placebo
Capsules matching NBI-827104 for oral administration


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04880616


Contacts
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Contact: Neurocrine Medical Information Call Center 877-641-3461 medinfo@neurocrine.com

Locations
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Netherlands
Neurocrine Clinical Site Recruiting
Leiden, CL, Netherlands, 2333
Sponsors and Collaborators
Neurocrine Biosciences
More Information
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Responsible Party: Neurocrine Biosciences
ClinicalTrials.gov Identifier: NCT04880616    
Other Study ID Numbers: NBI-827104-ET2016
2020-006012-24 ( EudraCT Number )
First Posted: May 11, 2021    Key Record Dates
Last Update Posted: April 14, 2022
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Neurocrine Biosciences:
Movement disorder
Tremor syndrome
Additional relevant MeSH terms:
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Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
 Nervous System Diseases
Movement Disorders
Central Nervous System Diseases