NCT07074002 Proof of Concept Study on BP1.4979 Effect on Essential Tremor
| NCT ID | NCT07074002 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Bioprojet |
| Condition | Essential Tremor |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-09-17 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2025-09-17 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility 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
Contact & Investigator
David Devos Coordinating Investigator, Pr
PRINCIPAL INVESTIGATOR
CHU de Lille
Frequently Asked Questions
Who can join the NCT07074002 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Essential Tremor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07074002 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07074002 currently recruiting?
Yes, NCT07074002 is actively recruiting participants. Contact the research team at a.karapet@bioprojet.com for enrollment information.
Where is the NCT07074002 trial being conducted?
This trial is being conducted at Amiens, France, Besançon, France, Bron, France, Clermont-Ferrand, France and 10 additional locations.
Who is sponsoring the NCT07074002 clinical trial?
NCT07074002 is sponsored by Bioprojet. The principal investigator is David Devos Coordinating Investigator, Pr at CHU de Lille. The trial plans to enroll 50 participants.