Outpatient Physical Therapy Intervention in Subjects With Parkinson's Disease Currently Using APOKYN®

NCT02549573 | Terminated Phase 4 Results

• 1 other identifier: USWM-AP1-4002
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 12

Brief Summary

To determine if PT intervention will be improved while in the "on" motor state vs. the "end-of-dose-off" motor state during the PT Intervention Visit in subjects with PD.

Conditions

Parkinson's Disease; Motor Symptoms

Keywords

Motor Symptoms; Parkinson's disease; Apokyn; Apomorphine; PD

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Activities-specific Balance Confidence (ABC) Scale

  Scale from 0 to 100% where an increase in percent represents an improvement in balance confidence.

  Baseline and after week 6

Secondary Outcomes (11)

• Change From Baseline in Movement Disorder Societies Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination)

  Baseline and after week 6

• Change From Baseline in Modified Physical Performance Test (M-PPT)

  Baseline and after week 6

• Change From Baseline in Timed-Up-and-Go (TUG) Test

  Baseline and after week 6

• Change From Baseline in 6-Minute Walk Test (6MWT)

  Baseline and after week 6

• Change From Baseline in Montreal Cognitive Assessment (MoCA)

  Baseline and after week 6

Other Outcomes (7)

• Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39)

  Baseline and after week 6

• Change From Baseline in Parkinson's Fatigue Scale (PFS-16)

  Baseline and after week 6

• Hospital Anxiety and Depression Scale - Change From Baseline in Anxiety

  Baseline and after week 6

Study Arms (2)

Apokyn treatment before physical therapy

ACTIVE COMPARATOR

APOKYN treatment before the PT Intervention Visit. Subjects in the "APO+" group will administer their usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.

Drug: APOKYN; Behavioral: Physical Therapy

Apokyn treatment withheld before physical therapy

OTHER

APOKYN treatment withheld before the PT Intervention Visit. Subjects in the "APO-" group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No "rescue therapy" will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation.

Behavioral: Physical Therapy

Interventions

APOKYN DRUG

Subjects in the APOKYN+ group will administer his/her usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.

Also known as: Apomorphine, APO

Apokyn treatment before physical therapy

Physical Therapy BEHAVIORAL

All subjects will participate in a standardized PT intervention

Also known as: PT

Apokyn treatment before physical therapy; Apokyn treatment withheld before physical therapy

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and sign an Investigational Review Board (IRB)-approved written informed consent and privacy language (e.g., Health Insurance Portability and Accountability Act (HIPAA) authorization) as per national regulations before any study-related procedures are performed.
• Must have a diagnosis of idiopathic PD.
• Adult male or female 18 to 78 years of age, inclusive.
• Currently using APOKYN, per the Package Insert, for at least 4 weeks before Baseline Assessment Visit(s).
• Currently using carbidopa/levodopa therapy at a steady maintenance dose, representing a stable treatment regimen in the opinion of the Investigator, for at least 4 weeks before Baseline Assessment Visit(s).
• Able to walk 50 feet independently (cane permissible) at the Baseline Assessment Visit.
• Meet all of the following parameters to demonstrate an optimal response to APOKYN at the APOKYN Response Verification Visit: must be "on" in the opinion of the subject and investigator within 20 minutes after the APOKYN injection; and have a motor state improvement of \>25% per the Movement Disorder Society (MDS)-UPDRS Motor Score (Part III), within 20 minutes after the APOKYN injection, as compared to pre-injection.
• Willing and able to comply with scheduled visits, treatment plan, other study-related procedures, and have available caregiver to provide transportation to clinic visits as needed.

You may not qualify if:

• Received PT targeting Parkinson's disease within 6 months before Baseline Assessment Visit(s).
• Received any investigational (i.e., unapproved) drug product within the last 30 days (or 5 half-lives, whichever is longer) before the Baseline Assessment Visit(s).
• Currently taking, or likely to need to take at any time during the course of the study, any 5HT3 antagonist (i.e., ondansetron, granisetron, dolasetron, palonosetron, alosetron).
• Currently on or likely to transition to the DUOPA (carbidopa and levodopa enteral suspension) during the course of the study.
• Has orthostatic hypotension (defined as \>30 mmHg decrease in systolic blood pressure or \>15 mmHg decrease in diastolic blood pressure within 2 minutes of standing from a supine position) at the Baseline Assessment Visit(s), or within 20 minutes following APOKYN injection at the APOKYN Verification Visit.
• Has a score of 24 or higher on the Modified Physical Performance Test (M-PPT).
• Has a score of 80% or higher on the Activities-specific Balance Confidence Scale (ABC).
• Has any significant current medical disorder, physical, or mental condition that would, in the Investigator's opinion, represent a hazard to the subject or prevent the subject from completing the study.
• Subjects with dementia, in the Investigator's opinion, or subjects with a Montreal Cognitive Assessment (MoCA) \<18.

Sponsors & Collaborators

• MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals: lead

Study Sites (12)

Unknown Facility

Phoenix, Arizona, 85013, United States

Location

Unknown Facility

Scottsdale, Arizona, 85258, United States

Location

Unknown Facility

Loma Linda, California, 92354, United States

Location

Unknown Facility

Sunnyvale, California, 94085, United States

Location

Unknown Facility

Orlando, Florida, 32803, United States

Location

Unknown Facility

Foxborough, Massachusetts, 02035, United States

Location

Unknown Facility

Cleveland, Ohio, 44106, United States

Location

Unknown Facility

Tulsa, Oklahoma, 74136, United States

Location

Unknown Facility

Hershey, Pennsylvania, 17033, United States

Location

Unknown Facility

Austin, Texas, 78746, United States

Location

Unknown Facility

Kirkland, Washington, 98034, United States

Location

Unknown Facility

Tacoma, Washington, 98409, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Apomorphine; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Aporphines; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 4 or More Rings; Therapeutics; Rehabilitation

Limitations and Caveats

Recruitment challenges (primarily due to standardized physical therapy requirements within sites) led to trial termination. The small number of subjects resulted in statistically unreliable results.

Results Point of Contact

• Title: Regulatory Affairs Specialist
• Organization: US WorldMeds

regulatoryaffairs@usworldmeds.com

Study Officials

• Mark Pirner, MD

  US WorldMeds

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: September 15, 2015
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 1, 2023
• Results First Posted: January 12, 2018

Record last verified: 2017-12

Locations

US (12)