Essential TremorPhase 2NCT04880616
Safety, Efficacy, and Tolerability of NBI-827104 for the Treatment of Essential Tremor
A Phase 2 study testing NBI-827104 in people with Essential Tremor, run by Neurocrine Biosciences at 1 site in Netherlands.
Trial summary
The main objective of this study is to evaluate the efficacy, safety, and tolerability of NBI-827104 in adults with essential tremor. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Essential Tremor
- What is being tested?
- NBI-827104
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Apr 2021to 8 Jun 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, 18 to 75 years of age, inclusive at screening.
- Body mass index (BMI) between 18 and 35 kg/m², inclusive, at screening.
- Diagnosis of Essential Tremor (inclusive of Essential Tremor plus) as defined by the Movement Disorders Society Consensus Criteria for Tremor.
- Confirmation of bilateral upper limb action tremor in the absence of overt dystonia, ataxia, or parkinsonism.
- History of onset of tremor before 65 years of age.
- 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.
- 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.
Who cannot join
- 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.
- Have direct or indirect trauma to the nervous system within 3 months preceding the onset of tremor.
- Have known history of other medical or neurological conditions that may cause or explain subject's tremor.
- Have had prior magnetic resonance guided focused ultrasound or surgical intervention (e.g., deep brain stimulation, ablative thalamotomy or gamma knife thalamotomy).
- Have a history or evidence of clinically significant cardiac conduction abnormality, uncontrolled bradyarrhythmia, heart failure, or long QT syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
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
The main objective of this study is to evaluate the efficacy, safety, and tolerability of NBI-827104 in adults with essential tremor.
- Conditions
- Essential Tremor
- Being tested
- NBI-827104, Placebo
- Keywords
- Movement disorder, Tremor syndrome
- Medical subject headings
- Essential Tremor, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBI-827104Drug
Capsules for oral administration
PlaceboDrug
Capsules matching NBI-827104 for oral administration
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: NBI-827104; Drug: Placebo |
| 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. Receives: Drug: NBI-827104; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to Day 28 of Each Treatment Period in Amplitude at Peak Frequency of Postural Tremor
Measured: Baseline and Day 28 of each treatment period
Secondary outcomes (3)
Change from Baseline in Essential Tremor Rating Assessment Scale (TETRAS) Performance Score
Measured: Baseline up to Day 28 of each treatment period
Change from Baseline in TETRAS Activities of Daily Living (ADL) Score
Measured: Baseline up to Day 28 of each treatment period
Clinical Global Impression of Change (CGI-C)
Measured: Up to Day 28 of each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start20 Apr 2021
- Primary completion25 May 2022
- Study completion8 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- More trials run by Neurocrine BiosciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurocrine Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Lead, Study director, Neurocrine Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880616
- Sponsor's protocol ID
- NBI-827104-ET2016
- Other IDs
- 2020-006012-24
- Status last verified
- Jul 2022
- First submitted
- 5 May 2021
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04880616
- Acronym / sponsor ID
- NBI-827104-ET2016
- Conditions
- Essential Tremor
- Keywords
- Movement disorder, Tremor syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Neurocrine BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 8 Jun 2022 (actual)
- First posted
- 11 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to evaluate the efficacy, safety, and tolerability of NBI-827104 in adults with essential tremor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: NBI-827104, Drug: PlaceboIn 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. |
| Sequence 2 | Experimental | Drug: NBI-827104, Drug: PlaceboIn 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female subjects, 18 to 75 years of age, inclusive at screening.
- Body mass index (BMI) between 18 and 35 kg/m², inclusive, at screening.
- Diagnosis of Essential Tremor (inclusive of Essential Tremor plus) as defined by the Movement Disorders Society Consensus Criteria for Tremor.
- Confirmation of bilateral upper limb action tremor in the absence of overt dystonia, ataxia, or parkinsonism.
- History of onset of tremor before 65 years of age.
Key exclusion criteria (5 listed)
- 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.
- Have direct or indirect trauma to the nervous system within 3 months preceding the onset of tremor.
- Have known history of other medical or neurological conditions that may cause or explain subject's tremor.
- Have had prior magnetic resonance guided focused ultrasound or surgical intervention (e.g., deep brain stimulation, ablative thalamotomy or gamma knife thalamotomy).
- Have a history or evidence of clinically significant cardiac conduction abnormality, uncontrolled bradyarrhythmia, heart failure, or long QT syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NBI-827104Capsules for oral administration | Drug | Sequence 1, Sequence 2 |
| PlaceboCapsules matching NBI-827104 for oral administration | Drug | Sequence 1, Sequence 2 |
Primary outcome
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
3 secondary outcomes
Change from Baseline in Essential Tremor Rating Assessment Scale (TETRAS) Performance Score
Time frame: Baseline up to Day 28 of each treatment period
Change from Baseline in TETRAS Activities of Daily Living (ADL) Score
Time frame: Baseline up to Day 28 of each treatment period
Clinical Global Impression of Change (CGI-C)
Time frame: Up to Day 28 of each treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development Lead study director
Neurocrine Biosciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NBI-827104 in people with Essential Tremor, run by Neurocrine Biosciences at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022.