NCT03781167

A Study to Evaluate the Safety and Tolerability of an active Drug in Subjects With Parkinson's Disease (PD)

Brief summary

The purpose of this study is to assess the safety and tolerability of an Active Drug in subjects with Parkinson's disease (PD).

Interventional

Interventional study

Status:
Completed
Conditions:
Parkinson's Disease (PD)
Enrollment:
244 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M15-741
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Masking:
None (Open Label)
Purpose:
Treatment

 

Eligibility criteria

Participant attributes:
Male and Female

Age:

30 Years and older.

Inclusion Criteria:

- Participants with diagnosis of idiopathic Parkinson's Disease (PD) that is
levodopa-responsive

- Participants must be judged by the investigator to be inadequately controlled by
current therapy, have recognizable/identifiable "Off" and "On" states (motor
fluctuations), and have a minimum of 2.5 hours of "Off" time per day

Exclusion Criteria:

- Participant is cognitively impaired and is not able to safely and effectively manage
the drug delivery system and the diaries and is not able to adhere to the study

- Participant is considered by the investigator to be an unsuitable candidate to receive
ABBV-951 for any reason

All the cities where the clinical studies are located

Calgary - T2N 4N1
Quebec City - G1W 4R4

Alberta

Calgary

Quebec

Quebec City

More information about this study

clinicaltrials.gov