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Taking people in FrancePhase 2

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

Key facts

Who runs it
Bioprojet
Where
Amiens, Besançon, Bron, Clermont-Ferrand, Créteil, Lille, Marseille, Nancy, Nice, Nîmes, Poitiers, Rennes, Strasbourg, and Toulouse, FranceSee the 14 sites
Trial code
Status
Recruiting
Phase
Phase 2
People taking part
50 people, planned
Started
17 Sept 2025
Expected to end
Dec 2026
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • BP1.4979
  • Placebo
Record updated
16 December 2025

Who can take part

Age
18 years to 85 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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 take part

  • 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
  • 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
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 85 years old?

Where in France

  • Chu Amiens PicardieAmiens, FranceContact: Study Medical DirectorNo longer taking part
  • CHU BesançonBesançon, FranceContact: Audace CURE-MARTINNot yet recruiting
  • Hospices Civils de Lyon - Hôpital Neurologique Pierre WertheimerBron, FranceContact: Mathilde MILLOT-TROESCHTaking people
  • CHU de Clermont-Ferrand Hôpital Gabriel MontpiedClermont-Ferrand, FranceContact: Study Medical DirectorNo longer taking part
  • CHU Henri MondorCréteil, FranceContact: Study Medical DirectorNo longer taking part
  • CHU De Lille, Hôpital Roger SalengroLille, FranceContact: Study Medical DirectorNo longer taking part
  • Centre Hospitalier Régional De Marseille - Hôpital de la TimoneMarseille, FranceContact: Study Medical DirectorNo longer taking part
  • CHRU Nancy - Hôpital centralNancy, FranceContact: Study Medical DirectorNo longer taking part
  • CHU de Nice - Hôpital Pasteur 2Nice, FranceContact: Study Medical DirectorNo longer taking part
  • CHU de NîmesNîmes, FranceContact: Study Medical DirectorNo longer taking part
  • CHU PoitiersPoitiers, FranceContact: Study Medical DirectorNo longer taking part
  • CHU Rennes - CHU PontchaillouRennes, FranceContact: Study Medical DirectorNo longer taking part
  • Hôpitaux Universitaires de Strasbourg - Hôpital de HautepierreStrasbourg, FranceContact: Hugo RUMMELNot yet recruiting
  • CHU Purpan - Bâtiment Pierre Paul RiquetToulouse, FranceContact: Amandine SAUBIONTaking people

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

* 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

The 2 groups in the trial

  • BP1.4979Treatment being tested

    One tablet of BP1.4979 taken twice daily for 4 weeks, approximately 8 to 10 hours apart

  • PlaceboPlacebo, for comparison

    One tablet of placebo taken twice daily for 4 weeks, approximately 8 to 10 hours apart

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Fit questions
Built from NCT07074002, who can take part
Record updated
16 December 2025