Boundless

Summary

This study focuses on individuals who have Parkinson's disease with poorly controlled or involuntary movement symptoms. The purpose of the study is to evaluate the effectiveness and safety of an investigational drug called ND0612, delivered under the skin, as a possible treatment for Parkinson's disease. ND0612 is a solution of levodopa/carbidopa (LD/CD) delivered as a continuous, subcutaneous (under the skin) infusion through a pump system to treat Parkinson's disease. It is not yet known how well the infusion treatment works compared with standard treatment (with tablets). In this study, oral LD/CD will be given on top of the infusion as needed. Researchers hope that the administration of LD and CD as a continuous infusion will result in more constant drug levels in the patient's blood, which may reduce Parkinson's symptoms more effectively than current standard treatment.


Inclusion Criteria

  • Male and female patients, aged ≥30 years.
  • PD diagnosis consistent with the UK Brain Bank Criteria.
  • Modified Hoehn & Yahr score ≤3 during ON.
  • Average of ≥2.5 hours of OFF time (≥2 hours OFF every day) during waking hours as confirmed by patient diary over 3 days.
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Study Location(s)

Beverly

More about this Clinical Trial

Full Title

A multicenter, randomized, active-controlled, double-blind, doubledummy,parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson's disease experiencing motor fluctuations

Details
Disease Type/Condition

Parkinson's Disease

Principal Investigator

Tagliati, Michele

Co-Investigators

Echo Tan, Elliot Hogg

Age Group

Adult

Phase

III

IRB Number

STUDY00000805

ClinicalTrials.gov ID

NCT04006210

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Parkinson's Disease

Principal Investigator

Tagliati, Michele

Age Group

Adult

Phase

III

IRB Number

ND0612-317

ClinicalTrials.gov ID

NCT04006210

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?