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

Essential Tremor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04880616
• Other study ID #: NBI-827104-ET2016
• Secondary ID: 2020-006012-24
• Status: Completed
• Phase: Phase 2
• Start date: April 20, 2021
• Est. completion date: June 8, 2022

Study information

• Verified date: July 2022
• Source: Neurocrine Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 8, 2022
• Est. primary completion date: May 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

Intervention

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

Locations

Country	Name	City	State
Netherlands	Neurocrine Clinical Site	Leiden	CL

Sponsors (1)

Lead Sponsor	Collaborator
Neurocrine Biosciences

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Change from Baseline in Essential Tremor Rating Assessment Scale (TETRAS) Performance Score		Baseline up to Day 28 of each treatment period
Secondary	Change from Baseline in TETRAS Activities of Daily Living (ADL) Score		Baseline up to Day 28 of each treatment period
Secondary	Clinical Global Impression of Change (CGI-C)		Up to Day 28 of each treatment period