BP1.4979 to reduce 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
See if BP1.4979, taken twice daily for four weeks, reduces tremors and is safe in adults with essential tremor.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Bioprojet Academic / other |
| Locations | 14 sites (Amiens and 13 other locations) |
| Trial ID | NCT07074002 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled Phase 2 trial tests BP1.4979, a drug acting on the dopamine pathway, in adults with essential tremor. Eligible participants aged 18–85 with confirmed ET and specific TETRAS-P scores will be randomized to BP1.4979 or matching placebo and will take the study medication twice daily for four weeks. The protocol includes five clinic visits over about 7–10 weeks, weekly diaries about daily impact, standardized tremor ratings (including TETRAS-P), and regular safety and tolerability monitoring. Outcomes will compare changes in tremor severity and adverse events between the active and placebo groups.
Who should consider this trial
Good fit: Adults 18–85 with a confirmed diagnosis of essential tremor for at least three years and a qualifying TETRAS-P score (≥1.5 in specified upper-limb tests), who meet the study’s safety and contraception requirements, are ideal candidates.
Not a fit: People with very severe tremor (TETRAS-P ≥3 in the specified tests), those unable to attend the French study sites, or with medical contraindications are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, BP1.4979 could reduce tremor severity and improve daily functioning for people with essential tremor.
How similar studies have performed: Drugs targeting dopamine receptors have shown benefits in related movement disorders such as Parkinson’s disease, but dopamine-targeted treatments for essential tremor remain relatively novel with limited proof-of-concept data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Amiens and 13 other locations
- 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)
Study contacts
- Principal investigator: David Devos Coordinating Investigator, Pr — CHU de Lille
- Study coordinator: Study Medical Director
- Email: a.karapet@bioprojet.com
- Phone: + 33 6 63 47 43 14
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.