A 12-Week Study of Flexilev With the OraFID Device and App in Parkinson's Patients
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 58
- 试验地点
- 5
- 主要终点
- Patient acceptability and satisfaction with the OraFID dosing device, self-reported via questionnaire
研究概览
简要总结
Flexilev is a Parkinson's disease medicine made of small, dissolvable tablets containing low doses of levodopa and carbidopa, allowing doses to be adjusted in small, precise steps. OraFID is a new mechanical device that dispenses the exact number of tablets needed, with better than 99% accuracy, in amounts from 1 to 20 tablets. An optional companion app, Levilog, reminds patients when to take their dose and records how much medicine (tablets and milligrams) was taken.
This 12-week study will mainly assess how acceptable this treatment routine is and how well patients stick with it when using Flexilev with the OraFID device and app. It will also evaluate the treatment's efficacy, safety, and tolerability.
详细描述
This is an open-label, observational, up to 12-week study evaluating patients' experience with Flexilev minitablets delivered through the OraFID dosing device and the Levilog reminder app.
Participants first complete an up-to-two-week run-in period, during which their current treatment is recorded and eligibility is assessed. Eligible patients then switch to Flexilev delivered by OraFID, are trained on the device and app, and receive an individualized dosing schedule based on their doctor's evaluation and prior treatment. Other daytime levodopa medications are stopped during the study, though slow-release levodopa is allowed at night; levodopa infusions are not permitted.
Within a week of starting treatment, patients receive a follow-up phone call to confirm or adjust the dosing schedule and check for any safety or device/app issues. This is followed by a 12-week treatment period, with phone check-ins at weeks 4 and 8 and an in-person visit at week 12. Dose adjustments are permitted throughout the study if needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects, 30 years of age or older at the time of screening, with a diagnosis of idiopathic PD that is levodopa-responsive
- •Have a minimum of 4 levodopa dosing occasions per day
- •Stable medication within the last 4 weeks
- •Be judged by the investigator to be eligible for Flexilev treatment.
- •Subject (or caregiver, if applicable) demonstrates the understanding and correct use of the OraFID delivery system, as assessed by the investigator or designee.
- •Subject (or caretaker on behalf of the subject) is willing to use Patients Own Reporting module in the Parkinson registry and is willing to answer all questionnaires.
- •Have a smartphone (either patient or caregiver)
- •Ability to consent and comply with study specific procedures
- •Able to read and write in Swedish
排除标准
- •Inability of subject or caregiver to use the device
- •Female patients who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical study and for three months later.
- •Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception.
研究组 & 干预措施
Flexilev with OraFID and App
Participants receive individualized Flexilev (levodopa/carbidopa) minitablet treatment delivered via the OraFID dosing device, with an optional Levilog reminder app to support dosing compliance, over a 12-week treatment period.
干预措施: OraFID dosing device, Levodopa/Carbidopa minitablets delivered via OraFID dosing device (Device)
结局指标
主要结局
Patient acceptability and satisfaction with the OraFID dosing device, self-reported via questionnaire
时间窗: 12 weeks
Assessed using a patient-reported questionnaire evaluating acceptability, ease of use, and satisfaction with the OraFID dosing device.
次要结局
- User opinion, usage, and ability to use the Levilog app(12 weeks)
- Time required per dispensation/treatment with the OraFID device(12 weeks)
- Compliance with the dosing schedule(12 weeks)
- Compliance with the app, i.e., willingness to register doses(12 weeks)
- Safety and acceptability of Flexilev delivered by OraFID and the app(12 weeks)
- Overall acceptability of Flexilev/OraFID/App(12 weeks)
- User opinion of Flexilev treatment(12 weeks)
- Change in non-motor symptoms(Baseline to week 12)
- Change in depression symptoms(Baseline to week 12)
- Change in quality of life(Baseline to week 12)
- Change in symptom variation (On-Off phenomena)(Baseline to week 12)
- Change in average daily normalized "off" time(Baseline to week 12)
- Change in average daily normalized "on" time without troublesome dyskinesia(Baseline to week 12)
- Change in sleep quality(Baseline to week 12)
- Motor function in daily life(12 weeks)
- Change in motor function (UPDRS Parts II and III)(Baseline to week 12)
- Change in disease severity(Baseline to week 12)
- Change in symptoms, treatment effects, and overall quality(Baseline to week 12)