Actively Recruiting
Proof of Concept Study on BP1.4979 Effect on Essential Tremor
Led by Bioprojet · Updated on 2025-12-16
50
Participants Needed
14
Research Sites
62 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Proof of Concept Study on BP1.4979 Effect on Essential Tremor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 85 years
- Confirmed diagnosis of essential tremor with bilateral upper limb action tremor lasting at least 3 years
- TETRAS-P score of at least 1.5 in specified upper extremity postures or movements
- For women: post-menopausal with at least 12 months of natural amenorrhea or using effective contraception during and for 1 month after the trial
You will not qualify if you...
- Severe tremor with TETRAS-P score of 3 or higher in specified upper extremity postures or tremor of the trunk
- Isolated head tremor without tremor in other body parts
- Medical, neurological, or psychiatric conditions that could cause tremors
- Taking medications that may induce tremors
- Nervous system injury or trauma within 3 months before tremor onset
- Using more than three drugs to treat essential tremor
- Previous treatments for essential tremor such as deep brain stimulation, brain lesioning, or MRI-guided procedures including focused ultrasound
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
CHU Amiens-Picardie
Amiens, France, 80054
Active, Not Recruiting
2
CHU Besançon
Besançon, France, 25030
Not Yet Recruiting
3
Hospices Civils De Lyon Hôpital Neurologique Pierre Wertheimer
Bron, France, 69500
Actively Recruiting
4
CHU de Clermont-Ferrand - Hôpital Gabriel Montpied
Clermont-Ferrand, France, 63003
Active, Not Recruiting
5
CHU Henri Mondor
Créteil, France, 94010
Active, Not Recruiting
6
CHU de Lille - Hôpital Roger SALENGRO
Lille, France, 59037
Active, Not Recruiting
7
Centre Hospitalier Régional De Marseille - Hôpital de la Timone
Marseille, France, 13005
Active, Not Recruiting
8
CHRU Nancy - Hôpital Central
Nancy, France, 54035
Active, Not Recruiting
9
CHU de Nice - Hôpital Pasteur 2
Nice, France, 06000
Active, Not Recruiting
10
CHU de Nîmes
Nîmes, France, 30029
Active, Not Recruiting
11
CHU Poitiers
Poitiers, France, 86000
Active, Not Recruiting
12
CHU Rennes - CHU Pontchaillou
Rennes, France, 35033
Active, Not Recruiting
13
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
Strasbourg, France, 67098
Not Yet Recruiting
14
CHU Purpan - Bâtiment Pierre Paul Riquet
Toulouse, France, 31059
Actively Recruiting
Research Team
S
Study Medical Director
CONTACT
C
Clinical Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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