A Cardiac Safety Study of an Investigational Drug to See How if Affects the Heart in People With Parkinson's Disease Complicated by Motor Fluctuations "OFF" Episodes

Completed · Phase 2 · Has a placebo group

Conditions studied: Parkinson's Disease, Off Episodes of Parkinson Disease

In brief

A cardiac safety study of an investigational drug to see how it affects the heart in people with Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)

Key facts

Study ID

NCT03187301

Run by

Sumitomo Pharma America, Inc.

People needed

48

Starts

2017-08-03

Expected to finish

2017-12-21

Last updated by the study team

2020-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1) Male or female ≥ 18 years of age. 2) Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the "more than one affected relative" criterion).
• Clinically meaningful response to Levodopa (L-Dopa). Subjects with or without well defined "OFF" episodes, as determined by the Investigator will be allowed.
• Receiving stable doses of L-Dopa/carbidopa (immediate or sustained release) administered at least 3 times per day OR Rytary™ administered 3 times per day, for at least 4 weeks before the initial Screening Visit (SV1). Subjects receiving L-Dopa/carbidopa 3 times a day must also be on stable treatment with adjunctive PD medication regimens. These regimens bust me maintained at a stable dose for at least 4 weeks prior to the initial Screening Visit (SV1) with the exception that MAO-B inhibitors must be maintained at a stable level for at least 8 weeks prior to the initial Screening Visit (SV1).
• No planned medication change(s) or surgical intervention anticipated during the course of study.
• the subject must be able to have a drug withdrawal induced "OFF" episode.
• Stage III or less on the modified Hoehn and Yahr scale in the "ON" state.
• Mini-Mental State Examination (MMSE) score > 21.
• If female and of childbearing potential, must agree to use one of the following methods of birth control throughout the study and until at least 30 days after final drug administration:
• Oral contraceptive
• Contraceptive patch
• Barrier (diaphragm, sponge or condom) plus spermicidal preparations
• Intrauterine contraceptive system
• Levonorgestrel implant
• Medroxyprogesterone acetate contraceptive injection
• Complete abstinence from sexual intercourse;
• Hormonal vaginal contraceptive ring; or
• Surgical sterilization or partner sterile (must have documented proof).
• Male subjects must be either surgically sterile, agree to be sexually abstinent or use a barrier method of birth control (e.g., condom) from first study drug administration until at least 30 days after final drug administration
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study-related procedures to complete the study.
• Able to understand the consent form, and to provide written informed consent.
• Must be approved as a satisfactory candidate by the Enrollment Authorization Committee (EAC) and the Sponsor.

You may not qualify if…

• Atypical or secondary parkinsonism
• Nausea associated with the use of dopamine agonists that requires treatment with an antiemetic.
• Previous treatment with any of the following: a neurosurgical procedure for PD; continuous subcutaneous (s.c.) apomorphine infusion; or Duodopa/Duopa.
• Treatment with any form of s.c. apomorphine within 7 days prior to the initial Screening Visit (SV1). Subjects that stopped s.c. apomorphine for any reason other than systemic safety concerns or lack of efficacy may be considered.
• Contraindications to moxifloxacin or APOKYN®, or hypersensitivity to apomorphine hydrochloride or any macrolide antibiotic or any of the ingredients of APOKYN® (notably sodium metabisulfite).
• Female who is pregnant or lactating.
• Participation in a clinical trial within 30 days prior to the initial Screening Visit (SV1), with the exception of clinical studies related to APL-13077.
• Receipt of any investigational (i.e., unapproved) medication within 30 days prior to the initial Screening Visit (SV1), with the exception of APL-13077.
• Any selective 5HT3 antagonists (i.e., ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (including Tigan [trimethobenzamide] and domperidone, but excluding quetiapine or clozapine) or dopamine depleting agents within 30 days prior to initial Screening Visit (SV1).
• Drug or alcohol dependency in the past 12 months.
• Subject has a history of malignancy within 5 years prior to SV1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Pituitary tumors of any duration are excluded.
• Documented abnormalities with ECGs including, arrhythmias, clinically meaningful interval irregularities, structural heart abnormalities ,myocardial infarction, presence or history of a pacemaker, or any abnormality of the ECG that in the opinion of the Investigator, would interfere with the ability to measure the QT interval, or correct the QT interval for heart rate.
• Male subjects with a screening corrected QT interval using Fridericia's formula (QTcF) of ≥ 450 ms; female subjects with a screening QT interval ≥ 470 ms. Eligibility will be based on the core laboratory ECG interpretation report.
• HR at screening < 45 bpm or > 100 bpm.
• QRS duration at screening >120 ms
• PR interval at screening >200 ms.
• Subjects with a history of cataplexy, unexplained syncope or seizures.
• Family history of sudden cardiac death.
• Heart failure (NYHA Class II or greater) and/or a myocardial infarction.
• Current use of any concomitant mediations that prolong the QT/QTc interval. Refer to https://crediblemeds.org for listing.
• History of additional risk factors for TdP (i.e., heart failure, hypokalemia, family history of Long QT Syndrome).
• Clinically significant medical, surgical, or laboratory abnormality in the opinion of the Investigator.
• Subject has a positive screening laboratory test result for human immunodeficiency virus (HIV).
• Subject has a positive screening laboratory test result for hepatitis B surface antigen or hepatitis C antibodies and has liver function test results at screening above the ULN for the reference laboratory.
• Major psychiatric disorder including, but not limited to, dementia, bipolar disorder, psychosis (including Parkinson's disease psychosis), or any disorder that, in the opinion of the Investigator, requires ongoing treatment that would make study participation unsafe or make treatment compliance difficult.

Where it is running

• Movement Disorders Center of Arizona — Scottsdale, Arizona, United States
• Clinical Trials, Inc. — Little Rock, Arkansas, United States
• The Parkinson's and Movement Disorder Institute — Fountain Valley, California, United States
• Parkinson's Disease and Movement Disorders Center of Boca Raton — Boca Raton, Florida, United States
• MD Clinical — Hallandale, Florida, United States
• Bioclinica Reserach — Orlando, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• The NeuroMedical Center, PC — Baton Rouge, Louisiana, United States
• QUEST Research Institute — Farmington Hills, Michigan, United States
• Central Texas Neurology Consultants — Round Rock, Texas, United States
• Casa di Cura villa Margherita (Neurologia) — Arcugnano, Italy
• Centro Ricerche San Raffaele — Cassino, Italy
• Agine Research Center, University Foundahon Chica-Pescara, Behavioral Neurology and Movement Disorders Unit — Chieti, Italy
• Neurologia, Policlinico Tor Vergata — Rome, Italy
• IRCCS San Raffaele Pisana,Clinical Trial Center — Rome, Italy

Full record on ClinicalTrials.gov

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