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8110 Gatehouse Road, Falls Church, VA 22042

A Double-blind, Placebo-controlled, Randomized, Phase 2a Study with Oral UCB0599 in Study Participants with Early Parkinson's Disease (Orchestra)

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General Information

Age Group

Adults

Status

Recruiting

Protocol Number

PD0053

Background Information

Research Question: The purpose of the study is to assess the safety and tolerability of UCB0599 and to demonstrate the superiority of UCB0599 over placebo with regard to clinical symptoms of disease progression over 12 and 18 months in participants diagnosed with early-stage Parkinson's disease.

Offered At

Inova Medical Group – Neurology
8081 Innovation Park Dr., #900
Fairfax, VA 22031

Eligibility Information

  • Study participant must be 40 to 70 years of age inclusive, at the time of signing the informed consent
  • Study participant has Parkinson's disease (PD), with a diagnosis made by a neurologist according to the 2015 Movement Disorder Society criteria within two years of Baseline Visit
  • The following diagnostic criteria must be met: bradykinesia AND at least ONE of the following: muscular rigidity, or resting tremor
  • Study participant has never taken medications for the treatment of motor symptoms of PD and is not expected to require starting symptomatic treatment (ST) with a high likelihood in the next 6 months as far as clinical judgement allows
  • Study participant has never taken part in disease-modifying treatment studies directed at neurodegenerative disease (NDD)

Ineligibility Information

  • Study participant has a known hypersensitivity to any components (and/or its excipients) of the study medication or comparative drugs as stated in the protocol
  • Study participant has any contraindication for the brain MRI or Dopamine Transporter Imaging with Single Photon Emission Computed Tomography (DaT-SPECT) imaging
  • Study participant has past history of use of medications for the treatment of motor symptoms of PD (with the exception of short pharmacological testing for confirmation of diagnosis) or drugs with a potential PD disease modifying effect

Additional information can be found at: https://clinicaltrials.gov/ct2/show/NCT04658186?term=PD0053&draw=2&rank=1