An Extension Study to Evaluate the Long-Term Efficacy, Safety and Tolerability of Minzasolmin (UCB0599) in Study Participants With Parkinson's Disease

Phase
Recruitment status
Participants
Lead sponsor
UCB Biopharma SRL
Start date
Number of sites

Summary
The purpose of the study is to estimate the pharmacodynamic effects of minzasolmin (UCB0599) on brain pathophysiology in Early-start versus Delayed-start participants originally diagnosed with new onset Parkinson's disease.
Short title
An Extension Study to Evaluate the Long-Term Efficacy, Safety and Tolerability of Minzasolmin (UCB0599) in Study Participants With Parkinson's Disease
Official title
A Dose-Blinded Extension Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of UCB0599 in Study Participants With Parkinson's Disease

Registry reports results
Listing at source
Recruitment status
Phase
Study type
Interventional
Reason stopped
Based on available data, the decision was made to stop development of UCB0599/minzasolmin as treatment of Parkinson's Disease.

Completion date
First posted
Registry last updated
Primary completion date
Start date

Actual participants
Participants
Participant count basis
Protocol amendments
Number of sites

Data monitoring committee
Registry sponsor category
Lead sponsor
UCB Biopharma SRL
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Not randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design

  1. Change From Baseline in Dopamine Transporter Imaging, Measured by Single Photon Emission Computed Tomography (DaT-SPECT), Whole Striatum Specific Binding Ratio up to PD0055 EOT or ET (Corresponding to a Visit Between PD0055 Month 6 and Month 18 Inclusive)

    Timeframe: From Baseline (PD0053 Screening Visit) up to PD0055 end of treatment (EOT) or early termination (ET) (corresponding to a visit between PD0055 Month 6 and Month 18 inclusive), up to 36 months post PD0053 Screening

    Change from PD0053 Baseline (screening) in mean striatum specific binding ratio (SBR) was assessed by DaT-SPECT using 123I-Ioflupane. Whole striatum was calculated as average of SBR data values for the four following "small" regions: left caudate, right caudate, left putamen, and right putamen. SBR was calculated for each region with the occipital cortex as a reference region. SBR = Average Small region minus Average Occipital region divided by Average Occipital region. Lower SBR indicated worse disease. Data were summarized by mapped visits: a DaT-SPECT within 2 months of PD0055 Screening was mapped to PD0053 Month 18; assessments after Month 23 from PD0053 Baseline were grouped as a single PD0055 EOT/ET visit.

  1. Cumulative Levodopa Equivalent Daily Dose (LEDD) at PD0055 Month 18

    Timeframe: From Baseline (PD0053 Screening Visit) to PD0055 Month 18, up to 36 months post PD0053 Screening

    The Cumulative Levodopa Equivalent Daily Dose (LEDD) was calculated for each participant at each visit, based on the dose level and frequency indicated on the concomitant medication form and at the end of study. This was the sum of all the LEDDs taken up to that visit. Any changes in medication (type, dose, or dosing regimen) were accounted for when calculating cumulative doses.

  2. Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

    Timeframe: From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)

    An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. The percentage of participants data was rounded to one decimal place.

  3. Percentage of Participants With Serious TEAEs

    Timeframe: From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)

    A SAE was defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent disability or incapacity, is a congenital anomaly or birth defect, and other important medical events which are based on medical or scientific judgement may jeopardise the participant's life, or may require medical or surgical intervention to prevent any of the above. The percentage of participants data was rounded to one decimal place.

  4. Percentage of Participants With TEAEs Leading to Withdrawal From the Study

    Timeframe: From PD0055 Baseline (Day 0) to the Safety Follow-up Visit (PD0055 Month 31)

    Percentage of participants with TEAEs leading to withdrawal from the study are presented. A TEAE was defined as any AE with a start date on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment in PD0055. The percentage of participants data was rounded to one decimal place.

Sources for outcomes

Sex
All
Age groups
Adults, Older adults
Minimum age
40 Years
Maximum age
78 Years
Healthy volunteers
No

  • Participant completed the Treatment Period of PD0053 (NCT04658186). The Baseline Visit for PD0055 (Visit 2) should be no later than 4 weeks following the end of treatment (EOT) Visit in PD0053 (NCT04658186). Any delay needs to be justified by the Investigator and approved by the Sponsor

  • A male study participant must agree to use contraception during the Treatment Period and for at least 90 days after the last dose of the IMP and refrain from donating sperm during this period.

  • A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:

    ◦ Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 1 month after the last dose of investigational medicinal product (IMP). The study participant must have a negative urine pregnancy test at Screening (Visit 1), which is to be confirmed negative by urine testing prior to the first dose of IMP at PD0055 Baseline Visit. If oral contraception is used, an additional barrier method will be required during the study as an IMP-related gastrointestinal upset or a drug interaction by cytochrome P450 3A4 (CYP3A4) induction could interfere with efficacy

  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent form (ICF) and in this protocol.

  • Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study
  • A female study participant who tests positive for pregnancy, plans to get pregnant during the participation in the study, or who is breastfeeding
  • Study participant had previously participated in PD0055
  • Study participant meets any withdrawal criteria in PD0053 (NCT04658186)
  • Study participants wearing any kind of implantable active device, including cardiac pacemakers, pumps, and implantable cardioverters, will be excluded from using Digital Health Technology, but may participate in the main study
  • Study participant does not agree to refrain from donating blood or blood products or other body fluids
Sources for eligibility

  • Pd0055 50506Phoenix, United States
  • Pd0055 50519Fountain Valley, United States
  • Pd0055 50385Fresno, United States
  • Pd0055 50118Los Angeles, United States
  • Pd0055 50531Englewood, United States
  • Pd0055 50392Danbury, United States
  • Pd0055 50538Farmington, United States
  • Pd0055 50396Boca Raton, United States
  • Pd0055 50524Bradenton, United States
  • Pd0055 50394Tampa, United States
  • Pd0055 50544Augusta, United States
  • Pd0055 50401Chicago, United States
  • Pd0055 50310Chicago, United States
  • Pd0055 50399Winfield, United States
  • Pd0055 50549Iowa City, United States
  • Pd0055 50074Kansas City, United States
  • Pd0055 50121Lexington, United States
  • Pd0055 50395New Orleans, United States
  • Pd0055 50547Baltimore, United States
  • Pd0055 50243Boston, United States
  • Pd0055 50546Worcester, United States
  • Pd0055 50386Farmington Hills, United States
  • Pd0055 50536Saint Paul, United States
  • Pd0055 50397Las Vegas, United States
  • Pd0055 50530Stony Brook, United States

And 71 more, listed on the interactive page.

Sources for sites

  • 2022-500424-30-00
  • U1111-1279-2323
Sources for references

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)