Intestinal pump reduces involuntary movements
- 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
- Intestinal pump reduces involuntary movements
- Status
- RECRUITING
- Sponsor
- Britannia Pharmaceuticals Ltd.
- Study Type
- OBSERVATIONAL
- Enrollment
- 215 participants
- Conditions
- Advanced Parkinson Disease
- Interventions
- No Intervention
Plain-Language Summary
The goal is to see whether LECIGON, a levodopa‑entacapone‑carbidopa intestinal gel, gives lasting control of motor fluctuations and dyskinesia in people with advanced Parkinson's who previously used subcutaneous foslevodopa. LECIGON is delivered continuously by a pump into the intestine, it supplies levodopa with carbidopa to prevent peripheral breakdown and entacapone to block COMT so levodopa stays active longer and blood levels are smoother, which can reduce off time and troublesome involuntary movements. The study is enrolling adults 18 and older with advanced Parkinson's and severe motor fluctuations or dyskinesia who a physician has decided to start on LECIGON and who have used subcutaneous foslevodopa for at least one month, while those with LECIGON contraindications, inability to manage pump therapy, severe dementia or substance misuse, or in another interventional trial are excluded.
Locations
- Virgen del Rocío University Hospital, Seville, Av. Manuel Siurot, S/n, Spain
- Complejo Hospitalario Universitario de A Coruña (CHUAC), A Coruña, Spain
Frequently Asked Questions
- What is this trial testing?
- This trial is studying No Intervention. The goal is to see whether LECIGON, a levodopa‑entacapone‑carbidopa intestinal gel, gives lasting control of motor fluctuations and dyskinesia in people with advanced Parkinson's who previously used subcutaneous foslevodopa. LECIGON is delivered continuously by a pump into the intestine, it supplies levodopa with carbidopa to prevent peripheral breakdown and entacapone to block COMT so levodopa stays active longer and blood levels are smoother, which can reduce off time and troublesome involuntary movements. The study is enrolling adults 18 and older with advanced Parkinson's and severe motor fluctuations or dyskinesia who a physician has decided to start on LECIGON and who have used subcutaneous foslevodopa for at least one month, while those with LECIGON contraindications, inability to manage pump therapy, severe dementia or substance misuse, or 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 2 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 2 years and 9 months.