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Enabling Women With Parkinson's Disease to Identify and Better Manage Hormonal Triggers of Parkinsonian Symptoms

Study acronym: Lady-PD
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study description expanded, about 6 words
    • Site details revised at 2 of 4 sites
  2. Notable Start date: Jan 21, 2025 to Mar 12, 2025
    • Study sites: 1 to 4
    • Primary completion date: Mar 2027 to Mar 12, 2027
    • Study completion date: Sep 2027 to Sep 12, 2027
    v4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2024 to Jan 21, 2025
    • Study sites: 0 to 1
    v3
  4. Minor Study description expanded, about 1 word
    • Collaborators shortened, about 3 words
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Forty percent of people living worldwide with Parkinson's disease (PD) are women. Twenty percent of patients have PD onset under the age of 60 years, a time when women may encounter significant caregiving responsibilities along with occupational and other competing demands. Studies with surveys of women with PD (WwPD) have reported worsening of PDrelated symptoms especially in the week prior and the week of menses. However, prospective evidence is scarce and clinical guidelines to manage this issue do not exist. As a result, care is either non-existent or fragmented. The investigators propose a French multicentre prospective pilot study to capture changes in PD symptoms in relation to the stages of the menstrual cycle aiming at reducing hormonal related worsening in PD symptoms through neurologist intervention and/or patient selfmanagement. Digital technology will remotely enable patient reported outcome (PRO) tracking through the My Moves Matter app changes in PD symptoms during several months. This information will then help neurologists to customize treatment. Changes in motor symptoms will also be highlighted by tracking through the use of a wearable device (PDMonitor) to objectively detect motor changes together with the app. This will further support the reliability of the app. This study will provide evidence for the impact of the menstrual cycle on PD and help neurologists and patients to better manage PD symptoms related to these hormonal changes.
Trial Details
NCT Number NCT06582212
Lead Sponsor University Hospital, Grenoble
Conditions
(from sponsor)
Digital Technology, Mobile Application, Motor Fluctuations, Oestrogen, Parkinson Disease
Related terms Parkinson Disease
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov