Proof of Concept Study on BP1.4979 Effect on Essential Tremor
NCT ID: NCT07074002
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
50 participants
INTERVENTIONAL
2025-09-17
2026-12-31
Brief Summary
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* 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
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BP1.4979
One tablet of BP1.4979 taken twice daily for 4 weeks, approximately 8 to 10 hours apart
BP1.4979
Selective dopamine D3 partial agonist
Placebo
One tablet of placebo taken twice daily for 4 weeks, approximately 8 to 10 hours apart
Placebo
Matching placebo of BP1.4979 tablet
Interventions
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BP1.4979
Selective dopamine D3 partial agonist
Placebo
Matching placebo of BP1.4979 tablet
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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Bioprojet
OTHER
Responsible Party
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Principal Investigators
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David Devos Coordinating Investigator, Pr
Role: PRINCIPAL_INVESTIGATOR
CHU de Lille
Locations
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CHU Amiens-Picardie
Amiens, , France
CHU Besançon
Besançon, , France
Hospices Civils De Lyon Hôpital Neurologique Pierre Wertheimer
Bron, , France
CHU de Clermont-Ferrand - Hôpital Gabriel Montpied
Clermont-Ferrand, , France
CHU Henri Mondor
Créteil, , France
CHU de Lille - Hôpital Roger SALENGRO
Lille, , France
Centre Hospitalier Régional De Marseille - Hôpital de la Timone
Marseille, , France
CHRU Nancy - Hôpital Central
Nancy, , France
CHU de Nice - Hôpital Pasteur 2
Nice, , France
CHU de Nîmes
Nîmes, , France
CHU Poitiers
Poitiers, , France
CHU Rennes - CHU Pontchaillou
Rennes, , France
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
Strasbourg, , France
CHU Purpan - Bâtiment Pierre Paul Riquet
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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P23-05/BP1.4979
Identifier Type: -
Identifier Source: org_study_id