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Tests treatment safety and results for Parkinson's Disease
Official title A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease
ClinicalTrials.gov ID: NCT07174310
What this study is testing
What is Prasinezumab?
Prasinezumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for parkinson's disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of prasinezumab compared with placebo in participants with early-stage Parkinson's disease (PD) on stable symptomatic monotherapy with levodopa.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 85
You may be able to join if
- Body weight within 40-110 kilograms (kg) (88-242 pounds [lbs]) and a body mass index within the range 18-34 kg/m2
- Diagnosis of idiopathic PD based on Movement Disorder Society (MDS) criteria
- Has received monotherapy treatment
- An MDS-UPDRS Part IV score of 0 at screening and prior to randomization
- Hoehn and Yahr (H\&Y) Stage 1 or 2 off medication at screening and prior to randomization
You likely can't join if
- Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
- Medical history indicating a parkinsonian syndrome other than idiopathic PD
- Diagnosis of a significant neurologic disease other than PD
- Chronic uncontrolled hypertension
See the full eligibility criteria
- Body weight within 40-110 kilograms (kg) (88-242 pounds [lbs]) and a body mass index within the range 18-34 kg/m2
- Diagnosis of idiopathic PD based on Movement Disorder Society (MDS) criteria
- Has received monotherapy treatment
- An MDS-UPDRS Part IV score of 0 at screening and prior to randomization
- Hoehn and Yahr (H\&Y) Stage 1 or 2 off medication at screening and prior to randomization
- Agreement to adhere to the contraception requirements
- Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
- Medical history indicating a parkinsonian syndrome other than idiopathic PD
- Diagnosis of a significant neurologic disease other than PD
- Chronic uncontrolled hypertension
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Fullerton, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- Pasadena, California, United States
- San Francisco, California, United States
- Englewood, Colorado, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Atlantis, Florida, United States
- Boca Raton, Florida, United States
- Lady Lake, Florida, United States
- Maitland, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Honolulu, Hawaii, United States
- Chicago, Illinois, United States
- Kansas City, Kansas, United States
+ 129 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Fullerton, California, United States; La Jolla, California, United States; Los Angeles, California, United States; Palo Alto, California, United States and 143 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.