Essential TremorPhase 2NCT07074002
Proof of Concept Study on BP1.4979 Effect on Essential Tremor
A Phase 2 study testing BP1.4979 in people with Essential Tremor, run by Bioprojet at 14 sites in France.
Trial summary
The goal of this clinical trial is to learn if drug BP1.4979 works to treat essential tremors in adults. It will also learn about the safety of drug BP1.4979. The main questions it aims to answer are: Does the drug BP1.4979 reduce tremors in individuals with essential tremor? Do participants have a good safety and… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Essential Tremor
- What is being tested?
- BP1.4979
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 14 sitesFrance
- Study dates
- 17 Sep 2025to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥18-85 years old
- Confirmed diagnosis of ET, characterized by meeting the following criteria: (a) the presence of a bilateral upper limb action tremor that occurs in isolation; (b) a minimum duration of 3 years; and (c) the tremor may or may not be present in other areas such as the voice, or lower limbs
- ET characterized by a TETRAS-P score of at least 1.5 in either the forward posture, wing beating posture, or finger-to-nose movement of at least one upper extremity
- Female patient: post-menopausal woman having at least 12 months of natural amenorrhea without any alternative medical cause, or woman of childbearing potential using a highly effective method of contraception for the duration of the trial and for 1 month after stopping the investigational medication
Who cannot join
- Severe tremor, defined as patient with ET characterized by a TETRAS-P score of ≥ 3 in either the forward posture, wing beating posture, or finger-to-nose movement of at least one upper extremity, or tremor of trunk
- Isolated head tremor not accompanied with tremor of any other body part
- Medical history or clinical evidence of any other conditions, whether medical, neurological, or psychiatric, that could potentially explain or contribute to the presence of tremors
- Patient who takes a medication which may induce tremor
- Direct or indirect injury or trauma to the nervous system within 3 months before the onset of tremor
- Concomitant treatment with more than three drugs to treat ET
- Any prior procedures for the treatment of ET such as deep brain stimulation, brain lesioning, or magnetic resonance (MR)-guided procedures, including MR-guided focused ultrasound
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
France14 sites, 4 recruiting
- Active, not recruiting
CHU Amiens-Picardie
Amiens, 80054
- Not yet recruiting
CHU Besançon
Besançon, 25030
Audace CURE-MARTIN, +33 3 81 21 84 76, acure@chu-besancon.fr
Matthieu BEREAU
- Recruiting
Hospices Civils De Lyon Hôpital Neurologique Pierre Wertheimer
Bron, 69500
Mathilde MILLOT-TROESCH, + 33 4 72 35 70 58, mathilde.millot-troesch@chu-lyon.fr
Stéphane PRANGE
- Active, not recruiting
CHU de Clermont-Ferrand - Hôpital Gabriel Montpied
Clermont-Ferrand, 63003
- Active, not recruiting
CHU Henri Mondor
Créteil, 94010
- Active, not recruiting
CHU de Lille - Hôpital Roger SALENGRO
Lille, 59037
- Active, not recruiting
Centre Hospitalier Régional De Marseille - Hôpital de la Timone
Marseille, 13005
- Active, not recruiting
CHRU Nancy - Hôpital Central
Nancy, 54035
- Active, not recruiting
CHU de Nice - Hôpital Pasteur 2
Nice, 06000
- Active, not recruiting
CHU de Nîmes
Nîmes, 30029
- Active, not recruiting
CHU Poitiers
Poitiers, 86000
- Active, not recruiting
CHU Rennes - CHU Pontchaillou
Rennes, 35033
- Not yet recruiting
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
Strasbourg, 67098
Hugo RUMMEL, +33 3 88 12 86 42, hugo.rummel@chru-strasbourg.fr
Christine TRANCHANT
- Recruiting
CHU Purpan - Bâtiment Pierre Paul Riquet
Toulouse, 31059
Amandine SAUBION, +33 5 61 77 25 07, amandine.saubion@inserm.fr
Marion SIMONETTA MOREAU
About this study
Official title: A Multicentre, Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of BP1.4979 in Adult Patients With Essential Tremor
The goal of this clinical trial is to learn if drug BP1.4979 works to treat essential tremors in adults. It will also learn about the safety of drug BP1.4979. The main questions it aims to answer are:
- Does the drug BP1.4979 reduce tremors in individuals with essential tremor?
- Do participants have a good safety and tolerability of drug BP1.4979?
Read more
Researchers will compare drug BP1.4979 to a placebo (a look-alike substance that contains no drug) to see if drug BP1.4979 works to treat essential tremors.
Participants will:
- Take the study drug (active or a placebo) twice daily over a 4-week period
- Visit the clinic 5 times for health checkups and questionnaires completion over a period of approximately 7 to 10 weeks
- Complete a diary weekly to assess the impact of essential tremor on daily life
Read the detailed description
Essential tremor (ET) is the most common form of movement-related tremor, affecting approximately 1% of the global population and up to 5% of individuals over 60 years old. This condition significantly impacts quality of life, as it often makes daily tasks difficult to perform.
Current treatments, mainly beta-blockers (e.g., propranolol), do not work for everyone and often cause bothersome side effects.
The exact causes of ET remain poorly understood, suggesting that it may be a syndrome (a group of related disorders) rather than a single disease. Brain imaging studies show that certain parts of the brain responsible for movement do not function normally, but it is not yet clear whether this is a disease that worsens over time.
Researchers believe that the brain chemical dopamine plays a key role in ET. One of dopamine receptors could be an interesting target for treatment. Drugs acting on this receptor have already shown positive results in other conditions, such as Parkinson's disease.
The objective of this trial is to develop a more effective treatment for ET, addressing an unmet medical need and improving the quality of life of affected patients.
The study drug, BP1.4979, acts on the dopamine pathway and is being tested to assess whether it can reduce tremors in individuals with ET. The study will compare BP1.4979 to a placebo (an identical-looking tablet with no active ingredient), taken twice daily over a 4-week period.
The study is a double-blind trial compared to a placebo, which means that neither the participants nor the study doctors know who is receiving the study drug or the placebo so as not to influence the results obtained. The treatments will be assigned randomly (by drawing lots), thus forming one group receiving BP1.4979 (20 mg) and another receiving the corresponding placebo.
A visit to the clinical site will take place at the beginning of the screening phase. Participants will be asked to sign an informed consent form before any study-related procedures.
Patients will then return to the clinical site to check whether they are eligible to take part in the study during the "randomization visit", and if so, they will receive study drug for 4 weeks of treatment.
Patients will be asked to complete a questionnaire once a week during the treatment period, to assess the impact of tremor on daily life.
Follow-up visits will take place every 2 weeks thereafter, at Week 2 (safety assessments) and Week 4 (end-of-treatment visit). A final visit will be made at Week 6 (15 days after stopping treatment) to check for or monitor any side effects.
- Conditions
- Essential Tremor
- Being tested
- BP1.4979, Placebo
- Keywords
- Essential Tremor
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BP1.4979Drug
Selective dopamine D3 partial agonist
PlaceboDrug
Matching placebo of BP1.4979 tablet
| Study group | Role | What they receive |
|---|---|---|
| BP1.4979 | Experimental | One tablet of BP1.4979 taken twice daily for 4 weeks, approximately 8 to 10 hours apart Receives: Drug: BP1.4979 |
| Placebo | Placebo comparator | One tablet of placebo taken twice daily for 4 weeks, approximately 8 to 10 hours apart Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Subscale of The Essential Tremor Rating Assessment Scale (TETRAS-P)
Change in the total score of the Performance Subscale of The Essential Tremor Rating Assessment Scale (TETRAS-P) after 4 weeks of treatment.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start17 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
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.
- 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
- Parallel groups
- Model description
- Multicentre, randomised, double-blind, placebo-controlled, parallel-group trial, proof of concept study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioprojet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Devos Coordinating Investigator, Pr, Principal investigator, CHU de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074002
- Sponsor's protocol ID
- P23-05/BP1.4979
- Status last verified
- Dec 2025
- First submitted
- 9 Jul 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of BP1.4979 in Adult Patients With Essential Tremor
- ClinicalTrials.gov ID
- NCT07074002
- Acronym / sponsor ID
- P23-05/BP1.4979
- Conditions
- Essential Tremor
- Keywords
- Essential Tremor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- BioprojetUniversity, hospital or other
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Jul 2025 (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 goal of this clinical trial is to learn if drug BP1.4979 works to treat essential tremors in adults. It will also learn about the safety of drug BP1.4979. The main questions it aims to answer are:
- Does the drug BP1.4979 reduce tremors in individuals with essential tremor?
- Do participants have a good safety and tolerability of drug BP1.4979?
Researchers will compare drug BP1.4979 to a placebo (a look-alike substance that contains no drug) to see if drug BP1.4979 works to treat essential tremors.
Participants will:
- Take the study drug (active or a placebo) twice daily over a 4-week period
- Visit the clinic 5 times for health checkups and questionnaires completion over a period of approximately 7 to 10 weeks
- Complete a diary weekly to assess the impact of essential tremor on daily life
Detailed description
Essential tremor (ET) is the most common form of movement-related tremor, affecting approximately 1% of the global population and up to 5% of individuals over 60 years old. This condition significantly impacts quality of life, as it often makes daily tasks difficult to perform.
Current treatments, mainly beta-blockers (e.g., propranolol), do not work for everyone and often cause bothersome side effects.
The exact causes of ET remain poorly understood, suggesting that it may be a syndrome (a group of related disorders) rather than a single disease. Brain imaging studies show that certain parts of the brain responsible for movement do not function normally, but it is not yet clear whether this is a disease that worsens over time.
Researchers believe that the brain chemical dopamine plays a key role in ET. One of dopamine receptors could be an interesting target for treatment. Drugs acting on this receptor have already shown positive results in other conditions, such as Parkinson's disease.
The objective of this trial is to develop a more effective treatment for ET, addressing an unmet medical need and improving the quality of life of affected patients.
The study drug, BP1.4979, acts on the dopamine pathway and is being tested to assess whether it can reduce tremors in individuals with ET. The study will compare BP1.4979 to a placebo (an identical-looking tablet with no active ingredient), taken twice daily over a 4-week period.
The study is a double-blind trial compared to a placebo, which means that neither the participants nor the study doctors know who is receiving the study drug or the placebo so as not to influence the results obtained. The treatments will be assigned randomly (by drawing lots), thus forming one group receiving BP1.4979 (20 mg) and another receiving the corresponding placebo.
A visit to the clinical site will take place at the beginning of the screening phase. Participants will be asked to sign an informed consent form before any study-related procedures.
Patients will then return to the clinical site to check whether they are eligible to take part in the study during the "randomization visit", and if so, they will receive study drug for 4 weeks of treatment.
Patients will be asked to complete a questionnaire once a week during the treatment period, to assess the impact of tremor on daily life.
Follow-up visits will take place every 2 weeks thereafter, at Week 2 (safety assessments) and Week 4 (end-of-treatment visit). A final visit will be made at Week 6 (15 days after stopping treatment) to check for or monitor any side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicentre, randomised, double-blind, placebo-controlled, parallel-group trial, proof of concept study
| Arm | Type | Receives |
|---|---|---|
| BP1.4979 | Experimental | Drug: BP1.4979One tablet of BP1.4979 taken twice daily for 4 weeks, approximately 8 to 10 hours apart |
| Placebo | Placebo comparator | Drug: PlaceboOne tablet of placebo taken twice daily for 4 weeks, approximately 8 to 10 hours apart |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female ≥18-85 years old
- Confirmed diagnosis of ET, characterized by meeting the following criteria: (a) the presence of a bilateral upper limb action tremor that occurs in isolation; (b) a minimum duration of 3 years; and (c) the tremor may or may not be present in other areas such as the voice, or lower limbs
- ET characterized by a TETRAS-P score of at least 1.5 in either the forward posture, wing beating posture, or finger-to-nose movement of at least one upper extremity
- Female patient: post-menopausal woman having at least 12 months of natural amenorrhea without any alternative medical cause, or woman of childbearing potential using a highly effective method of contraception for the duration of the trial and for 1 month after stopping the investigational medication
Key exclusion criteria (7 listed)
- Severe tremor, defined as patient with ET characterized by a TETRAS-P score of ≥ 3 in either the forward posture, wing beating posture, or finger-to-nose movement of at least one upper extremity, or tremor of trunk
- Isolated head tremor not accompanied with tremor of any other body part
- Medical history or clinical evidence of any other conditions, whether medical, neurological, or psychiatric, that could potentially explain or contribute to the presence of tremors
- Patient who takes a medication which may induce tremor
- Direct or indirect injury or trauma to the nervous system within 3 months before the onset of tremor
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 |
|---|---|---|
| BP1.4979Selective dopamine D3 partial agonist | Drug | BP1.4979 |
| PlaceboMatching placebo of BP1.4979 tablet | Drug | Placebo |
Primary outcome
Performance Subscale of The Essential Tremor Rating Assessment Scale (TETRAS-P)
Time frame: 4 weeks
Change in the total score of the Performance Subscale of The Essential Tremor Rating Assessment Scale (TETRAS-P) after 4 weeks of treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Essential Tremor
Recruiting
Effects of Microelectrode-based Brain Stimulation in Humans
Essential Tremor, Parkinsons Disease (PD)
Recruiting
Deep Brain Stimulation Surgery for Movement Disorders
Parkinson's Disease, Essential Tremor
RecruitingObservational study
The Encora X1™ in a Real World Observational Study
Essential Tremor
Active, not recruitingObservational study
Identifying Markers of Disease Subtypes and Disease Progression in the Syndrome of Essential Tremor
Essential Tremor
RecruitingPhase 2
Study of AGN-151607-DP to Assess Adverse Events and Change in Disease Activity in Adult Participants With Upper Limb Essential Tremor
Upper Limb Essential Tremor
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.
David Devos Coordinating Investigator, Pr principal investigator
CHU de Lille
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BP1.4979 in people with Essential Tremor, run by Bioprojet at 14 sites in France.
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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Medical Director (+ 33 6 63 47 43 14, a.karapet@bioprojet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance Subscale of The Essential Tremor Rating Assessment Scale (TETRAS-P) (time frame: 4 weeks). 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 16 Dec 2025.