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

ConditionEssential Tremor
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorBioprojet

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • BP1.4979

    Drug

    Selective dopamine D3 partial agonist

  • Placebo

    Drug

    Matching placebo of BP1.4979 tablet

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: BP1.4979Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
4 weeks

Secondary outcomes

Other outcomes

1

Global satisfaction questionnaire

Assessment of patient satisfaction with the study drug compared to any previously used anti-tremor medication via the global satisfaction questionnaire.

Time frame
4 weeks
2

Patient reported outcome (PRO)

Change in patient's experience via the patient reported outcome (PRO) assessing the impact of essential tremors on daily living.

Time frame
4 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bioprojet

Lead sponsor

Source ClinicalTrials.gov
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