BridgeMD
A trial to test whether ORE-001 (oral lidocaine) leads to increased food intake and improved health and wellbeing in elderly underweight people
EU CTIS ID: 2024-516958-22-00
What this study is testing
To evaluate the efficacy of oral ORE-001, in comparison to placebo, in increasing the amount of food intake of a standardized lunch on day 1 and day 42
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant must be able to understand the requirements of the study and give written informed consent prior to the study start.
- Females and males aged between 65 and 85 years (both inclusive).
- BMI at baseline 20 (kg/m2) or less
- Male participants enrolled in this study must take appropriate precautions to prevent pregnancy in their female partners of childbearing potential during the study period. To minimize the risk of pregnancy, participants and their partners are required to use one of the following medically approved contraceptive methods throughout the study: -Hormonal contraception (e.g., oral contraceptive pills, vaginal ring, contraceptive injection, contraceptive implant, or intrauterine device [IUD]). -Female sterilization (e.g., bilateral tubal occlusion or tubal ligation). -Male sterilization (vasectomy). Participants must commit to adhering to one of these methods and are also required to abstain from sperm donation for the duration of the study. The study investigator will provide guidance on the most appropriate contraceptive measures based on individual circumstances. Participants should discuss these requirements with their partners to ensure compliance. These measures do not apply if female partner is postmenopausal
- If a participant's female partner becomes pregnant during the study, the participant must seek her consent to notify the study investigator. If the partner provides consent, the pregnancy will be monitored closely, and relevant clinical data regarding the pregnancy's course and outcome may be obtained from healthcare providers to ensure appropriate follow-up. Additionally, the pregnancy will be reported to the study sponsor in accordance with regulatory requirements. No data will be collected or disclosed without the pregnant partner’s informed consent.
You likely can't join if
- Any contraindication as per summary of product characteristics of any local anesthetics
- A participant practicing a vegetarian or vegan diet
- Any food allergy or food intolerance (except lactose, gluten, fructose, histamine)
- Impaired renal function (eGFR < 45 ml/min at the discretion of the study investigator)
- Any experimental agent within 30 days or 5 half-lives, whichever is longer, prior to study medication administration or participation in another clinical trial that overlaps with the duration of the present trial.
- A participants with any familial or close personal relationship with the study investigator or persons working at the respective Investigational Site or participants who are an employee of the Sponsor
See the full eligibility criteria
Who can join
- Participant must be able to understand the requirements of the study and give written informed consent prior to the study start.
- Females and males aged between 65 and 85 years (both inclusive).
- BMI at baseline 20 (kg/m2) or less
- Male participants enrolled in this study must take appropriate precautions to prevent pregnancy in their female partners of childbearing potential during the study period. To minimize the risk of pregnancy, participants and their partners are required to use one of the following medically approved contraceptive methods throughout the study: -Hormonal contraception (e.g., oral contraceptive pills, vaginal ring, contraceptive injection, contraceptive implant, or intrauterine device [IUD]). -Female sterilization (e.g., bilateral tubal occlusion or tubal ligation). -Male sterilization (vasectomy). Participants must commit to adhering to one of these methods and are also required to abstain from sperm donation for the duration of the study. The study investigator will provide guidance on the most appropriate contraceptive measures based on individual circumstances. Participants should discuss these requirements with their partners to ensure compliance. These measures do not apply if female partner is postmenopausal
- If a participant's female partner becomes pregnant during the study, the participant must seek her consent to notify the study investigator. If the partner provides consent, the pregnancy will be monitored closely, and relevant clinical data regarding the pregnancy's course and outcome may be obtained from healthcare providers to ensure appropriate follow-up. Additionally, the pregnancy will be reported to the study sponsor in accordance with regulatory requirements. No data will be collected or disclosed without the pregnant partner’s informed consent.
What rules you out
- Any contraindication as per summary of product characteristics of any local anesthetics
- A participant practicing a vegetarian or vegan diet
- Any food allergy or food intolerance (except lactose, gluten, fructose, histamine)
- Impaired renal function (eGFR < 45 ml/min at the discretion of the study investigator)
- Any experimental agent within 30 days or 5 half-lives, whichever is longer, prior to study medication administration or participation in another clinical trial that overlaps with the duration of the present trial.
- A participants with any familial or close personal relationship with the study investigator or persons working at the respective Investigational Site or participants who are an employee of the Sponsor
- A participant who is highly likely not able to comply with the protocol requirements and to complete the study in the opinion of the study investigator
- Impaired hepatic function (transaminase levels > 2 times higher than upper limit of normal)
- Hypotension (diastolic blood pressure ≤ 60 mmHg)
- Participant with uncontrolled hypertension (diastolic blood pressure ≥ 100 mmHg)
- Clinically significant abnormal ECG (at the discretion of the study investigator)
- Abnormal TSH levels (≥ 4.0 mU/L)
- Increased methemoglobin level (≥ 3%)
- Participant with uncontrolled diabetes type I or II.
- History of COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) COPD Grade ≥ 2).
- Participants with a history or current congestive heart failure
- Participants with malignancies or lymphoproliferative disorders within previous 5 years (except for basal cell carcinoma)
- History of severe allergic or anaphylactic reactions to local anesthetics
- Current intake of any drugs qualifying as class 1B antiarrhythmic drugs (e.g., Lidocaine, Mexiletine, Phenytoin) and as any class 3 antiarrhythmic drugs - Potassium channel blockers (e.g., Amiodarone, Dronedarone, Sotalol, Ibutilide, Dofetilide, Bretylium), irrespective of the indication for the drug.
- Current intake of any antacids (e.g., Calcium Carbonate, Magnesium Hydroxide, Aluminum Hydroxide, Sodium Bicarbonate, Magnesium Trisilicate)
- Significant (at the discretion of the study investigator) symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection (especially with the need for systemic antibiotic or antimycotic treatment) within the past 2 weeks prior to study medication administration.
- Excessive alcohol intake (≥ 14 units / week).
- Major abdominal surgery interfering with gastrointestinal function, at the discretion of the study investigator (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed)
- Dieting one month or less prior to screening, particularly the practice of regulating or restricting types and amounts of food consumed to achieve or maintain a particular health outcome (e.g. weight management), including structured plans like low-carb diets, low-fat diets, intermittent fasting, balanced diets (e.g., Mediterranean), and other specialized dietary regimens
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.