No Intervention for Parkinson's (NCT07313176)
Decrease hours when medications stop
- Trial ID
- NCT07313176
- Official Title
- A Prospective, Non-Interventional Study on the Long-term Effectiveness of Levodopa-Entacapone-Carbidopa Intestinal Gel (LECIGON®) in Patients With Parkinson's Disease Previously Treated With Subcutaneous Foslevodopa in Routine Care
- Goal
- Decrease hours when medications stop
- Status
- RECRUITING
- Sponsor
- Britannia Pharmaceuticals Ltd.
- Study Type
- OBSERVATIONAL
- Enrollment
- 215 participants
- Conditions
- Advanced Parkinson Disease
- Interventions
- No Intervention
Summary For Families
The study is looking at whether LECIGON® cuts down daily OFF time, the hours each day when Parkinson's medications stop working and symptoms return, measured after 12 months using Part IV of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale. It is an observational follow-up of people who start LECIGON®, a levodopa-entacapone-carbidopa intestinal gel usually delivered by a pump into the intestine, tracking how OFF time changes over a year; participants must have been treated with subcutaneous foslevodopa for at least one month before switching. Adults 18 and older with advanced Parkinson's who have severe motor fluctuations and involuntary movements are eligible if their doctor has decided to start LECIGON® per the product information. People with contraindications to LECIGON®, those who cannot use or be followed for pump therapy, those with severe dementia, agitation, or alcohol abuse, or those in another interventional trial are excluded.
Locations
- Complejo Hospitalario Universitario de A Coruña (CHUAC), A Coruña, A Coruña, Spain
- Virgen del Rocío University Hospital, Seville, Av. Manuel Siurot, S/n, Spain
- Hospital Universitario de Toledo, Toledo, Castille-La Mancha, Spain
- Hospital de Cruces, Barakaldo, Vizcaya, Spain
- Hospital de Basurto, Bilbao, Vizcaya, Spain
Frequently Asked Questions
- What is this trial testing?
- This trial is studying No Intervention. The study is looking at whether LECIGON® cuts down daily OFF time, the hours each day when Parkinson's medications stop working and symptoms return, measured after 12 months using Part IV of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale. It is an observational follow-up of people who start LECIGON®, a levodopa-entacapone-carbidopa intestinal gel usually delivered by a pump into the intestine, tracking how OFF time changes over a year; participants must have been treated with subcutaneous foslevodopa for at least one month before switching. Adults 18 and older with advanced Parkinson's who have severe motor fluctuations and involuntary movements are eligible if their doctor has decided to start LECIGON® per the product information. People with contraindications to LECIGON®, those who cannot use or be followed for pump therapy, those with severe dementia, agitation, or alcohol abuse, or those in another interventional trial are excluded.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 5 locations.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 2 years and 5 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Injection (minimally invasive). Confirm the full schedule with the study coordinator.