A 12-Week Trial of Flexilev with the OraFID Device and App for Parkinson's

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label study will evaluate the acceptability, adherence, safety, and tolerability of Flexilev minitablets delivered by the OraFID dosing device in people with Parkinson's disease who respond to levodopa. Participants follow a run-in period, switch to Flexilev with OraFID, and receive an individualized dosing plan with ongoing remote and in-person follow-ups over 12 weeks. Dosing is adjusted as needed, and concomitant daytime levodopa regimens are interrupted while nighttime slow-release levodopa is allowed; the Levilog app records dosing and reminders. The study uses a caregiver or patient-reported data module to capture adherence and patient experience, with efficacy explored through standard clinical monitoring during visits and calls.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Where it's running

• Uppsala University Hospital
  Uppsala, Uppsala County, Sweden Recruiting
• Skane University Hospital
  Lund, Sweden Recruiting
• Karolinska University Hospital
  Stockholm, Stockholm County, Sweden Not yet recruiting
• Sahlgrenska universitetssjukhuset
  Gothenburg, Sweden Not yet recruiting
• Centrum för Neurologi
  Stockholm, Sweden Not yet recruiting

Study contacts

• Study coordinator: Dag Nyholm, Professor
• Email: dag.nyholm@uu.se
• Phone: 0046186115003

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.