Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2025-12-25 @ 3:40 AM
NCT ID:
NCT07074002
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
Detailed Description:
Essential tremor (ET) is the most common form of movement-related tremor, affecting approximately 1% of the global population and up to 5% of individuals over 60 years old. This condition significantly impacts quality of life, as it often makes daily tasks difficult to perform.
Current treatments, mainly beta-blockers (e.g., propranolol), do not work for everyone and often cause bothersome side effects.
The exact causes of ET remain poorly understood, suggesting that it may be a syndrome (a group of related disorders) rather than a single disease. Brain imaging studies show that certain parts of the brain responsible for movement do not function normally, but it is not yet clear whether this is a disease that worsens over time.
Researchers believe that the brain chemical dopamine plays a key role in ET. One of dopamine receptors could be an interesting target for treatment. Drugs acting on this receptor have already shown positive results in other conditions, such as Parkinson's disease.
The objective of this trial is to develop a more effective treatment for ET, addressing an unmet medical need and improving the quality of life of affected patients.
The study drug, BP1.4979, acts on the dopamine pathway and is being tested to assess whether it can reduce tremors in individuals with ET. The study will compare BP1.4979 to a placebo (an identical-looking tablet with no active ingredient), taken twice daily over a 4-week period.
The study is a double-blind trial compared to a placebo, which means that neither the participants nor the study doctors know who is receiving the study drug or the placebo so as not to influence the results obtained. The treatments will be assigned randomly (by drawing lots), thus forming one group receiving BP1.4979 (20 mg) and another receiving the corresponding placebo.
A visit to the clinical site will take place at the beginning of the screening phase. Participants will be asked to sign an informed consent form before any study-related procedures.
Patients will then return to the clinical site to check whether they are eligible to take part in the study during the "randomization visit", and if so, they will receive study drug for 4 weeks of treatment.
Patients will be asked to complete a questionnaire once a week during the treatment period, to assess the impact of tremor on daily life.
Follow-up visits will take place every 2 weeks thereafter, at Week 2 (safety assessments) and Week 4 (end-of-treatment visit). A final visit will be made at Week 6 (15 days after stopping treatment) to check for or monitor any side effects.
Study:
NCT07074002
Study Brief:
Protocol Section:
NCT07074002