Ireland
--:--IST
Recruiting Phase 2

Proof of Concept Study on BP1.4979 Effect on Essential Tremor

NCT07074002 · tracked via the Priya Life Science France tracker
Sponsor
Phase
Phase 2
Started
2025-09-17
Last updated
2025-12-16

Condition(s) studied

Essential Tremor

Investigational drug(s) / intervention(s)

BP1.4979 →Placebo

BP1.4979: Selective dopamine D3 partial agonist

Placebo: Matching placebo of BP1.4979 tablet

Study 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

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

  • Performance Subscale of The Essential Tremor Rating Assessment Scale (TETRAS-P) — 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.

Trial sites (14)

FacilityCityRegionStatus
CHU Amiens-Picardie Amiens France Active Not Recruiting
CHU Besançon Besançon France Not Yet Recruiting
Hospices Civils De Lyon Hôpital Neurologique Pierre Wertheimer Bron France Recruiting
CHU de Clermont-Ferrand - Hôpital Gabriel Montpied Clermont-Ferrand France Active Not Recruiting
CHU Henri Mondor Créteil France Active Not Recruiting
CHU de Lille - Hôpital Roger SALENGRO Lille France Active Not Recruiting
Centre Hospitalier Régional De Marseille - Hôpital de la Timone Marseille France Active Not Recruiting
CHRU Nancy - Hôpital Central Nancy France Active Not Recruiting
CHU de Nice - Hôpital Pasteur 2 Nice France Active Not Recruiting
CHU de Nîmes Nîmes France Active Not Recruiting
CHU Poitiers Poitiers France Active Not Recruiting
CHU Rennes - CHU Pontchaillou Rennes France Active Not Recruiting
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre Strasbourg France Not Yet Recruiting
CHU Purpan - Bâtiment Pierre Paul Riquet Toulouse France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07074002 on ClinicalTrials.gov ↗ ← All trials in France