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

Sponsor
Bioprojet
Study ID
NCT07074002
Phase
PHASE2
Status
Recruiting
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Conditions

  • Essential Tremor

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • BP1.4979 — DRUG
    Selective dopamine D3 partial agonist
  • Placebo — DRUG
    Matching placebo of BP1.4979 tablet

Study Details

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

Key Dates

First listed
Jul 20, 2025
Start date
Sep 17, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BP1.4979
    One tablet of BP1.4979 taken twice daily for 4 weeks, approximately 8 to 10 hours apart
  • Placebo Comparator: Placebo
    One tablet of placebo taken twice daily for 4 weeks, approximately 8 to 10 hours apart

Primary Outcome Measure

Performance Subscale of The Essential Tremor Rating Assessment Scale (TETRAS-P) [ Time Frame: 4 weeks ]

Central Contacts

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