Clinical trials
Trial design, recruitment, interim and final results, regulatory updates.
In this category
State of the art
No update yet for Clinical trials. An update is a standalone state-of-the-art for the topic — what someone with Parkinson's needs to know about where this approach stands today.
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Observations on an Open‐Label Phase 1/2 Dopamine Gene Therapy Trial (OXB‐102/Axo‐Lenti‐PD) in People with Parkinson's Disease Trial readouts
Provides the definitive peer-reviewed record of a terminated Phase 1/2 open-label dopamine gene therapy trial (n=6, two dose cohorts), previously documented only in press releases and conference abstracts — a key data-preservation step for informing successor trial designs. -
Co‐ and Multi‐Pathologies in Parkinson's Disease: An International Parkinson and Movement Disorder Society Scientific Issues Committee Review Trial design & recruitment
The review explicitly argues that uncharacterised co-pathology burden is a major but largely unaddressed source of heterogeneity in PD trial populations — a patient's response to an alpha-synuclein-targeting therapy could be masked or confounded by concurrent Alzheimer or vascular pathology — and calls for routine multi-pathology biomarker screening as part of standard PD trial design. -
PD GENEration: An International Parkinson's Disease Genetic Research Study Trial design & recruitment
PD GENEration is explicitly designed as a recruitment pipeline for genetics-targeted precision-medicine trials: participants found to carry GBA1 or LRRK2 variants are informed of eligible trials, and the 20,000+ participant registry with whole-genome sequencing is being made publicly available through GP2 to accelerate trial design. The transition to WGS also enables identification of a 21-gene expanded PD panel alongside secondary findings (BRCA1/2, Lynch syndrome, familial hypercholesterolemia genes), broadening the return-of-results model used in trial recruitment. -
バイオジェンとデナリ、パーキンソン病治療薬の開発を中止 執筆 - Investing.com - FX | 株式市場 | ファイナンス | 金融ニュース Trial readouts
The Phase 2b LUMA study is a high-profile negative readout: BIIB122 met neither its primary endpoint (time to confirmed worsening on MDS-UPDRS Parts II+III combined) nor any secondary endpoints, resulting in programme discontinuation for idiopathic Parkinson's disease. Full data are to be presented at an upcoming scientific conference. -
Safety and efficacy of faecal microbiota transplantation in Parkinson’s disease Trial readouts
This 2026 review synthesises results from five FMT randomised controlled trials in Parkinson's, highlighting a critical methodological problem: donor selection, delivery route, pre-treatment, and follow-up duration varied so widely that cross-trial comparison is unreliable. The authors argue this heterogeneity — not a lack of biological signal — is the main obstacle to a definitive answer, and call for larger, protocol-standardised RCTs. -
Cellular Intelligence acquires global rights to STEM-PD program Trial design & recruitment
The STEM-PD Phase 1/2 trial targets adults aged 50–75 with moderate Parkinson's of more than 10 years' duration whose symptoms are not well controlled by oral therapies; eight participants have been enrolled at two sites (UK and Sweden), and the FDA has now cleared advancement into Phase 2 development. -
Cell Replacement Approval in Japan and Other Cell Therapy Updates
The speakers provide context on the regulatory pathways and the cautious, phased approach required to move cell-based therapies from laboratory research into safe, viable clinical treatments for Parkinson's. -
Phase 3 trial of solengepras for Parkinson’s disease now fully enrolled Trial design & recruitment
The Phase 3 ARISE trial (NCT06553027) testing solengepras has completed enrollment of 341 participants with motor fluctuations (≥3 hours daily off time) across 94 sites internationally, with topline data expected in Q3 2026. -
Vyalev eases motor, nonmotor symptoms in advanced Parkinson’s Trial readouts
Six-month interim results from ROSSINI (NCT06107426), an AbbVie-funded 10-country observational study of 427 adults, were published in Neurology and Therapy and represent the first prospective real-world readout for Vyalev; a 12-month interim analysis in 200 patients is planned next. -
Multi-locus genetic dosage shapes cognitive disease progression in Parkinson’s patients: 15-year meta-analysis of 24 cohorts Trial design & recruitment
The authors highlight that a multi-locus genetic dosage score could sharpen trial recruitment by enrolling patients most likely to experience cognitive endpoints within a trial window. The 7.49-fold risk difference between zero and three-or-more variants suggests that genetically stratified enrolment could substantially reduce the sample sizes needed to detect a cognitive benefit in dementia-prevention studies. -
Tolerability and efficacy of full-body head-up tilt sleeping in Parkinson’s disease and multiple system atrophy Trial readouts
The Heads-Up trial (NCT05551377) reports its primary tolerability and efficacy results: a non-pharmacological, positional intervention reached its proof-of-concept endpoints in a 20-person PD/MSA cohort, with measurable blood-pressure benefits at moderate bed angles. The trial was funded by the Michael J. Fox Foundation and establishes the dose-response and tolerability profile needed to design a larger efficacy study. -
Daily‐Life, Sensor‐Derived Tremor Measures Are Sensitive to Progression in Early Parkinson's Disease Trial design & recruitment
Because the sensor-derived tremor measures are far more sensitive to change than annual clinical ratings, adopting them as outcome measures in early-PD trials could meaningfully reduce the sample size or follow-up time needed to detect whether a disease-modifying treatment is working — a practical advance for trial design. -
Driving motor cortex oscillations restores plasticity and improves bradykinesia features in Parkinson’s disease
This double-blind, sham-controlled trial (ClinicalTrials.gov NCT06297538, registered March 7, 2024) is among the first to demonstrate that a non-invasive brain stimulation protocol targeting gamma oscillations produces statistically robust motor improvements in a Parkinson's cohort, supporting progression to larger efficacy trials.