What Is Prasinezumab?
Prasinezumab is a drug currently being investigated in clinical trials. It is administered as an intravenous (IV) infusion. While its specific mechanism of action is not detailed in the available trial descriptions, it is being studied for its potential role in treating Parkinson's Disease. There are currently 3 clinical trials involving Prasinezumab, with a total enrollment of 1,606 participants. The first trial began in March 2021, and the latest trial is expected to conclude in September 2025.Uses and Conditions Under Study
Prasinezumab is currently being studied for the treatment of Parkinson's Disease. Parkinson's Disease is a progressive neurological disorder that primarily affects movement. Symptoms often include tremors, stiffness, slow movement, and problems with balance and coordination. The clinical trials involving Prasinezumab aim to evaluate its safety and effectiveness in potentially managing this condition. All 3 clinical trials for Prasinezumab are focused on Parkinson's Disease, with studies sponsored by Hoffmann-La Roche and University Hospital Tuebingen.Dosing
Prasinezumab is administered as an intravenous (IV) infusion. Clinical trials have investigated a dose of 1500 mg given monthly. Participants typically receive Prasinezumab as an IV infusion according to a specified schedule, often described as every 4 weeks (Q4W). The studies also include a placebo arm for comparison to assess the drug's effects.Side Effects
In a clinical trial involving Prasinezumab for early Parkinson's disease (with 292 patients in the drug arm), the most commonly reported side effect was back pain. A total of 15.8% of patients taking Prasinezumab experienced back pain, compared to 13.8% of patients receiving a placebo.
Other common side effects reported in the trial, listed by their frequency in patients taking Prasinezumab, include:
- Nasopharyngitis (common cold symptoms): 12.3% of patients on Prasinezumab experienced this, compared to 10.7% on placebo.
- Fall: 11.6% of patients on Prasinezumab experienced a fall, compared to 10.3% on placebo.
- Infusion related reaction: 10.6% of patients on Prasinezumab experienced a reaction during or after infusion, compared to 12.4% on placebo.
- Headache: 9.2% of patients on Prasinezumab experienced headaches, compared to 6.2% on placebo.
- Arthralgia (joint pain): 8.9% of patients on Prasinezumab experienced joint pain, compared to 8.6% on placebo.
- Urinary tract infection: 8.2% of patients on Prasinezumab experienced a urinary tract infection, compared to 11.0% on placebo.
- Fatigue: 7.2% of patients on Prasinezumab experienced fatigue, compared to 3.8% on placebo.
Some side effects, such as infusion related reactions and urinary tract infections, were reported slightly less often in patients taking Prasinezumab compared to those on placebo.
Clinical Trial Results
The efficacy and safety of Prasinezumab were evaluated in a study of participants with early Parkinson's disease (NCT04777331). This study compared Prasinezumab to a placebo over 76 weeks, with approximately 292 participants in each treatment arm.
Impact on Motor Function and Disease Progression
One key finding was the time to worsening of participants' motor function. Patients receiving Prasinezumab experienced a delay in motor function worsening, with a median time of 112.1 weeks, compared to 88.3 weeks for those on placebo. This represents a delay of nearly 24 weeks.
The time to a confirmed motor progression event, as measured by the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, was also delayed. Patients on Prasinezumab reached this milestone at a median of 61.1 weeks, compared to 49.7 weeks for the placebo group, showing a delay of over 11 weeks.
Regarding overall motor function, the mean change in the MDS-UPDRS Part III score from baseline to Week 76 indicated a smaller worsening in the Prasinezumab group. Patients on Prasinezumab had a mean change of 3.61 units, while those on placebo had a mean change of 4.00 units. A lower score indicates less worsening of motor symptoms.
Other measures of disease progression also showed delays with Prasinezumab:
- Time to meaningful worsening in clinician-assessed global impression of change: 60.6 weeks for Prasinezumab vs. 52.1 weeks for placebo.
- Time to meaningful worsening in participant-assessed global impression of change: 44.4 weeks for Prasinezumab vs. 36.1 weeks for placebo.
- Time to onset of motor complications (MDS-UPDRS Part IV): 100.1 weeks for Prasinezumab vs. 91.1 weeks for placebo.
Safety and Tolerability
In the NCT04777331 study, adverse events (AEs) were reported by 267 participants (91.4%) in the Prasinezumab arm and 260 participants (89.0%) in the placebo arm. Serious adverse events (SAEs) occurred in 34 participants (11.6%) in both the Prasinezumab and placebo arms. Infusion-related reactions were reported by 32 participants (11.0%) on Prasinezumab and 37 participants (12.7%) on placebo. Treatment discontinuation due to adverse events was low, occurring in 2 participants (0.7%) in the Prasinezumab group and 3 participants (1.0%) in the placebo group.
Currently Recruiting Trials
For individuals interested in contributing to medical research, a significant clinical trial for Prasinezumab is actively recruiting participants. This study focuses on evaluating the potential of Prasinezumab as a treatment for early-stage Parkinson's disease.
The trial, known as NCT07174310, is a Phase 3 study sponsored by Hoffmann-La Roche. Its primary goal is to assess the efficacy, safety, and pharmacokinetics of intravenous (IV) Prasinezumab. Participants will receive either Prasinezumab or a placebo, and the study will compare these outcomes in individuals with early-stage Parkinson's disease who are already on stable symptomatic monotherapy with levodopa. The trial aims to enroll approximately 900 participants, making it a substantial effort to understand Prasinezumab's role in managing this condition.
Where to Participate
The clinical trial for Prasinezumab is designed to be widely accessible, with study sites located across the United States. There are currently 37 sites across 37 cities in 23 states actively recruiting participants. This broad geographic reach allows more individuals to potentially join the study.
Eligibility criteria for participation include individuals between 50 and 85 years of age, of any gender. It is important to note that this study is not seeking healthy volunteers or children; participants must have early-stage Parkinson's disease. Some of the top recruiting locations include:
- Birmingham, Alabama
- Phoenix, Arizona
- Fullerton, California
- Los Angeles, California
- Palo Alto, California
- Pasadena, California
- San Francisco, California
- Englewood, Colorado
- New Haven, Connecticut
- Washington D.C., District of Columbia
Development Timeline
The journey of Prasinezumab in clinical development began on March 2, 2021, marking the start of its first clinical trial. Initially, the drug's research focused on conditions such as IBS-C and hyperphosphatemia. Over time, the development pipeline for Prasinezumab expanded to include Parkinson's Disease, reflecting an evolving understanding of its potential therapeutic applications.
Development has progressed through various stages, with two trials reaching Phase 2 and one trial advancing to Phase 3. The primary sponsor driving much of this research has been Hoffmann-La Roche, with additional contributions from the University Hospital Tuebingen. To date, a total of 3 clinical trials have been initiated for Prasinezumab, collectively aiming to enroll 1,606 participants. The latest projected completion date for a Prasinezumab trial is September 15, 2025, indicating ongoing commitment to understanding its full potential.