Infusion of Apomorphine: Long-term Safety Study

• Register: ClinicalTrials.gov
• Last refreshed on: 6 May 2024
• Main ID: NCT02339064
• Date of registration: 31/03/2014
• Prospective Registration: Yes
• Primary sponsor: MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals
• Public title: Infusion of Apomorphine: Long-term Safety Study INFUS-ON
• Scientific title: A Phase 3, Open-Label Study of the Safety, Efficacy and Tolerability of Apomorphine Administered by Continuous Subcutaneous Infusion in Advanced Parkinson's Disease Patients With Unsatisfactory Control on Available Therapy
• Date of first enrolment: February 2015
• Target sample size: 99
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02339064
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Gianpiera Ceresoli-Borroni, PhD
• Affiliation: Supernus Pharmaceuticals, Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Advanced idiopathic PD consistent with UK Parkinson's Disease Society Brain Bank
Clinical Diagnostic Criteria

- Overall motor control is unsatisfactory in the opinion of the Investigator and subject
despite optimized treatment with available therapies, which must include a stable
regimen of daily maintenance levodopa (or levodopa/carbidopa), and at least one of the
following other classes of therapies:

- Dopamine agonists (note: APOKYN intermittent injection is not to be considered here)

- Monoamine oxidase B [MAO B] inhibitors

- Catechol-O-methyltransferase (COMT) inhibitors

- Deep brain stimulation (DBS)

- Levodopa/carbidopa intestinal gel surgery (Duopa, Duodopa)

- Other - amantadine at doses of up to 400 mg per day)

- Experiences "off" periods averaging =3.0 hours per waking day

- Other criteria will be discussed in detail with potential subjects by site
Investigator

Exclusion Criteria:

- Planned surgical intervention for the treatment of Parkinson's disease during
participation in the study

- History of hypersensitivity to apomorphine hydrochloride or any of the ingredients of
APOKYN PFS, including sodium metabisulfite

- Known, suspected, or planned pregnancy or lactation.

- Recent history (within the previous 12 months) of alcohol or substance abuse

- History of impulsive/compulsive behaviors primarily associated with the use of
dopamine agonists

- History of previously treated or current diagnosis of malignant melanoma

- Exhibits certain signs and symptoms of cardiovascular disease

- Other criteria will be discussed in detail with potential subjects by site
Investigator



Age minimum: 30 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Parkinson's Disease

Intervention(s)

Drug: apomorphine infusion

Primary Outcome(s)

Percent of daily "off" time during the waking day [Time Frame: Baseline Visit to Week 12]

Secondary Outcome(s)

Parkinson's Disease Questionnaire [Time Frame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits]

Frequency and total dose of average daily intermittent injection APOKYN for subjects on APOKYN treatment at study entry [Time Frame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits]

Patient Global Impression of Severity (PGI-S) and Change (PGI-C) Scale [Time Frame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits]

Percent daily "on" time without troublesome dyskinesias during waking day [Time Frame: Baseline Visit to Week 12]

Percent of daily "on" time without dyskinesias [Time Frame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits]

Unified Parkinson's Disease Rating Scale - Motor Score [Time Frame: Baseline Visit to Week 12]

United Parkinson's Disease Rating Scale - Activities of Daily Living Score [Time Frame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits]

Clinical Global Impression of Severity (CGI-S) and Change (CGI-C) Scale [Time Frame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits]

Percent of daily "off" time during the waking day [Time Frame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits]

Percent of daily "on" time without troublesome dyskinesias during the waking day [Time Frame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits]

Proportion of responders [Time Frame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits]

Secondary ID(s)

USWM-AP2-3000

Source(s) of Monetary Support

Please refer to primary and secondary sponsors