BP1.4979 to reduce essential tremor.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hospices Civils De Lyon Hôpital Neurologique Pierre Wertheimer
  Bron, France Recruiting
• CHU Purpan - Bâtiment Pierre Paul Riquet
  Toulouse, France Recruiting
• CHU Amiens-Picardie
  Amiens, France Active not recruiting
• CHU Besançon
  Besançon, France Not yet recruiting
• CHU de Clermont-Ferrand - Hôpital Gabriel Montpied
  Clermont-Ferrand, France Active not recruiting
• CHU Henri Mondor
  Créteil, France Active not 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Microelectrode-based brain stimulation for Parkinson’s and essential tremor

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• Non-Invasive Nerve Stimulation for Essential Tremor: Long-Term Safety and Effectiveness

  This study tests whether a non-invasive stimulation device called TAPS helps reduce tremor in adults with essential tremor over a long period.

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• Low Intensity Focused Ultrasound for Essential Tremor in Adults

  This early-stage, open-label study tests whether repeated low-intensity focused ultrasound can safely and briefly modulate tremor in people with essential tremor.

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• Closed-loop TMS to reduce tremor

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  Recruiting University of Oxford · Oxford, Oxfordshire · NCT07574164

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.