---
title: Document motor complications despite medication
nct_id: NCT07330258
status: RECRUITING
sponsor: Bayer
study_type: OBSERVATIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT07330258"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07330258"
last_fetched: "2026-05-10T14:02:31.016Z"
source: "Parkinson's Pathways (curated)"
---
# Document motor complications despite medication

**Goal (in five words):** Document motor complications despite medication

**Official Title:** A Natural History Study of Treated Parkinson's Disease Patients Experiencing Motor Complications

**Trial ID:** [NCT07330258](https://clinicaltrials.gov/study/NCT07330258)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Sponsor:** Bayer
- **Target Enrollment:** 300 participants
- **Start Date:** 2026-04-30
- **Completion Date:** 2032-12-21
- **Conditions:** Parkinson's Disease
- **Interventions:** Standard of Care
- **Intervention Types:** OTHER

## Summary For Families

Goal: Learn how motor complications and OFF time progress over time in people with Parkinson's who are already being treated with levodopa, so researchers can better describe symptom patterns and treatment responses.  
Approach: Participants stay on their usual care while the team regularly records motor ratings, ON/OFF response to the first daily dose, medication use, and other clinical measures; no new drug or device is given.  
Eligibility: Adults 45 to 75 years old with clinically established PD diagnosed 4 to under 12 years ago, Hoehn and Yahr stage II,III OFF, MDS‑UPDRS part III score ≥30 OFF, at least 1 hour OFF time per day, on a stable levodopa regimen (≥300 mg/day or ≥3 doses/day) with a clear levodopa response, MoCA ≥24; people with prior DBS or levodopa pumps, major uncontrolled medical or psychiatric conditions, pregnancy, or current interventional trial participation are excluded, and a care partner aged ≥18 may also join.

## Eligibility

- **Minimum age:** 45 Years
- **Maximum age:** 75 Years
- **Sex:** ALL

### Full Criteria

```
Inclusion Criteria for Patient:

* Individual of any sex ≥45 to ≤75 years of age at informed consent (at least 30% ≤60 years of age).
* Diagnosis of clinically established Parkinson's disease (PD) as defined by the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for PD ≥4 and \<12 years from time of PD diagnosis at informed consent.
* Modified H\&Y stage II-III in the practically defined OFF-medication state (≥12 hours from last dose of antiparkinsonian medications).
* Score of ≥30 on MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III in the OFF-medication state.
* Presence of motor fluctuations with ≥1 hour of absolute time in the OFF state per day as assessed by clinician/patient at screening.
* Receiving stable antiparkinsonian medication regimen for ≥4 weeks prior to screening with a levodopa daily dose ≥300 mg or a dosing frequency of ≥3 times per day.
* Responsiveness to levodopa as determined by change in the following measures from the practically defined OFF state to ON state after taking typical first-daily dose of PD-medications: i. any degree of improvement (≥0.5 point) in modified H\&Y stage OR. ii. ≥30% improvement in MDS-UPDRS part III score.
* Montreal Cognitive Assessment (MoCA) score of ≥24.
* Agree to participate and provide signed informed consent.

Exclusion Criteria for Patient:

* Known history or presence of conditions that may provide an alternative to a PD diagnosis including but not limited to: multiple system atrophy, progressive supranuclear palsy, striatonigral degeneration, corticobasal syndrome/degeneration, vascular Parkinsonism, drug-induced Parkinsonism, essential tremor, diffuse Lewy body disease, Lewy body dementia, Huntington's disease, Wilson's disease, Fahr's disease, Alzheimer's disease, cerebrovascular disease, brain tumor, trauma, and infection.
* Known history or presence of significant vascular and/or cardiovascular disease limited to: stroke, transient ischemic attacks, poorly controlled hypertension, poorly controlled diabetes, unstable angina pectoris, or unstable myocardial infarction.
* Known history or presence of significant psychosis or impulse control disorder, or untreated or sub optimally treated depression.
* Known history or presence of human immunodeficiency virus, hepatitis B virus, hepatitis C virus, syphilis, or tuberculosis.
* Current or previously active malignant disease within the past 5 years, except definitively treated cutaneous squamous cell carcinoma, basal cell carcinoma, or in situ uterine cervical carcinoma.
* Currently pregnant, nursing, lactating, breastfeeding, or plan to be during study duration.
* Known history or current use of percutaneous levodopa/carbidopa intestinal gel, subcutaneous levodopa, or apomorphine pump.
* Prior history of brain surgery, including but not limited to: deep brain stimulation (DBS), pallidotomy, focused ultrasound thalamotomy, or other experimental neurosurgical procedure.
* Known history or current participation in cell or gene therapy procedures.
* Current participation in any interventional clinical trial.

Inclusion Criteria for Care Partner:

* ≥18 years of age at informed consent.
* Identified by the PD patient as their primary care partner.
* Agree to participate and the ability to provide signed informed consent independently, without the need for a legal representative.

Exclusion Criteria for Care Partner:

* Not applicable.
```

## Locations (5)

- The Parkinson's & Movement Disorder Institute, Fountain Valley, California, United States _(33.7092, -117.9537)_
- Keck School of Medicine, Los Angeles, California, United States _(34.0522, -118.2437)_
- Boston University, Boston, Massachusetts, United States _(42.3584, -71.0598)_
- University of Texas Health Science Center at Houston, Houston, Texas, United States _(29.7633, -95.3633)_
- University of Vermont, Burlington, Vermont, United States _(44.4759, -73.2121)_

## Central Contacts

- Bayer Clinical Trials Contact — (CONTACT) — (+)1-888-84 22937 — clinical-trials-contact@bayer.com

---

*Canonical: https://parkinsonspathways.com/trial/NCT07330258*  
*HTML version: https://parkinsonspathways.com/trial/NCT07330258*  
*Source data: https://clinicaltrials.gov/study/NCT07330258*