A Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 in an Outpatient Environment

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AbbVie

Status and phase

Completed
Phase 1

Conditions

Parkinson's Disease (PD)

Treatments

Drug: ABBV-951

Study type

Interventional

Funder types

Industry

Identifiers

NCT03374917
M15-739

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of 4 weeks of continuous infusion with ABBV-951 in adult subjects with Parkinson's Disease (PD).

Enrollment

20 patients

Sex

All

Ages

30 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subject with a diagnosis of definite idiopathic Parkinson's disease (PD) that is levodopa-responsive according to the United Kingdom Parkinson's Disease Society Brain Bank Criteria.
  • Subject must be taking an optimized and stable regimen of oral medications for PD, which has remained stable and unchanged for at least 30 days before enrollment in this study.
  • Subject is judged inadequately controlled on current therapy in the opinion of the Investigator and must experience a minimum of 2.5 hours of "off" time per day prior to Enrollment.
  • Subjects with a MMSE score greater than or equal to 24 and considered by the Investigator to not have dementia.

Exclusion criteria

  • Subjects with clinically significant electrocardiogram (ECG) values.
  • History of significant skin conditions or disorders that in the Investigator's opinion would interfere with the infusion of the study drug or could interfere with study assessments.
  • Receipt of an investigational product within at least 6 weeks prior to study drug administration.
  • Subjects with moderate to severe kidney disease.
  • Consideration by the investigator for any reason that the subject is an unsuitable candidate to receive ABBV-951.
  • Patient/caregiver that cannot demonstrate proper use of the devices (drug pump and wearable device) will not be allowed to participate.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

ABBV-951
Experimental group
Description:
ABBV-951 administered by continuous subcutaneous infusion (CSCI) for 4 weeks.
Treatment:
Drug: ABBV-951

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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