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

NCT07074002 | Recruiting Phase 2 DMC

• 1 other identifier: P23-05/BP1.4979
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 14

Brief 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

Conditions

Essential Tremor

Keywords

Essential Tremor

Outcome Measures

Primary Outcomes (1)

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

  Change in the total score of the Performance Subscale of The Essential Tremor Rating Assessment Scale (TETRAS-P) after 4 weeks of treatment.

  4 weeks

Other Outcomes (2)

• Global satisfaction questionnaire

  4 weeks

• Patient reported outcome (PRO)

  4 weeks

Study Arms (2)

BP1.4979

EXPERIMENTAL

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

Drug: BP1.4979

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

BP1.4979 DRUG

Selective dopamine D3 partial agonist

BP1.4979

Placebo DRUG

Matching placebo of BP1.4979 tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bioprojet: lead

Study Sites (14)

CHU Amiens-Picardie

Amiens, 80054, France

ACTIVE NOT RECRUITING

CHU Besançon

Besançon, 25030, France

NOT YET RECRUITING

Hospices Civils De Lyon Hôpital Neurologique Pierre Wertheimer

Bron, 69500, France

RECRUITING

CHU de Clermont-Ferrand - Hôpital Gabriel Montpied

Clermont-Ferrand, 63003, France

ACTIVE NOT RECRUITING

CHU Henri Mondor

Créteil, 94010, France

ACTIVE NOT RECRUITING

CHU de Lille - Hôpital Roger SALENGRO

Lille, 59037, France

ACTIVE NOT RECRUITING

Centre Hospitalier Régional De Marseille - Hôpital de la Timone

Marseille, 13005, France

ACTIVE NOT RECRUITING

CHRU Nancy - Hôpital Central

Nancy, 54035, France

ACTIVE NOT RECRUITING

CHU de Nice - Hôpital Pasteur 2

Nice, 06000, France

ACTIVE NOT RECRUITING

CHU de Nîmes

Nîmes, 30029, France

ACTIVE NOT RECRUITING

CHU Poitiers

Poitiers, 86000, France

ACTIVE NOT RECRUITING

CHU Rennes - CHU Pontchaillou

Rennes, 35033, France

ACTIVE NOT RECRUITING

Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

Strasbourg, 67098, France

NOT YET RECRUITING

CHU Purpan - Bâtiment Pierre Paul Riquet

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• David Devos Coordinating Investigator, Pr

  CHU de Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Medical Director

CONTACT

+ 33 6 63 47 43 14; a.karapet@bioprojet.com

Clinical Project Manager

CONTACT

+ 33 1 84 75 34 01; s.abid@bioprojet.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentre, randomised, double-blind, placebo-controlled, parallel-group trial, proof of concept study

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 20, 2025
• Study Start: September 17, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (14)