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Observational, Long-term, Extension Study for Participants of Prior VY-AADC01 or VY-AADC02 Studies

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ClinicalTrials.gov Identifier: NCT03733496
Recruitment Status : Enrolling by invitation
First Posted : November 7, 2018
Last Update Posted : March 27, 2019
Sponsor:
Collaborator:
Voyager Therapeutics
Information provided by (Responsible Party):
Neurocrine Biosciences

Brief Summary:
An extension study for participants who have completed VY-AADC01 or VY-AADC02 Studies

Condition or disease
Parkinson Disease

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational, Long-Term Extension Study for Participants of Prior VY-AADC01 or VY-AADC02 Clinical Studies
Actual Study Start Date : August 24, 2018
Estimated Primary Completion Date : August 2026
Estimated Study Completion Date : August 2026

Resource links provided by the National Library of Medicine


Group/Cohort
Participants from VY-AADC01 or VY-AADC02 clinical studies
Participants who have finished participating in Voyager-sponsored VY-AADC01 or VY-AADC02 clinical studies will be invited to participate in this extension study



Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 8 years ]
    Long-term safety of VY-AADC as assessed by Adverse Events and Serious Adverse Events


Secondary Outcome Measures :
  1. Change in AADC enzyme activity [ Time Frame: 8 years ]
    Continued expression of AADC as measured by [18F]-fluorodopa (F-Dopa) positron emission tomography (PET)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Participants from prior VY-AADC01 or VY-AADC02 clinical studies will be eligible for the extension study
Criteria

Inclusion Criteria:

  1. Participant in Voyager-sponsored clinical study of VY-AADC01 or VY-AADC02 gene therapy
  2. Ability to comprehend and signed the informed consent, or for participants who are not capable of providing consent, have a healthcare proxy, or person with power of attorney, who is able and willing to give consent on behalf of the participant
  3. Capable of complying with the protocol

Exclusion Criteria:

None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03733496


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
Neurocrine Biosciences
Voyager Therapeutics
Investigators
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Study Director: Steve Hersch, MD Voyager Therapeutics, Inc.
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Responsible Party: Neurocrine Biosciences
ClinicalTrials.gov Identifier: NCT03733496    
Other Study ID Numbers: PD-1104
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
Keywords provided by Neurocrine Biosciences:
PD
Parkinson's Disease
Aromatic L-Amino Acid Decarboxylase
AADC
AAV2
AAV2-AADC
VY-AADC
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases