Proof of Concept Study on BP1.4979 Effect on Essential Tremor
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
Bioprojet
50 participants
Sep 17, 2025
INTERVENTIONAL
Conditions
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 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
Eligibility
Inclusion Criteria4
- 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
Exclusion Criteria7
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Selective dopamine D3 partial agonist
Matching placebo of BP1.4979 tablet
Locations(14)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07074002