Apokyn for Motor IMProvement of Morning AKinesia Trial (AM IMPAKT) (AM IMPAKT)
Parkinson's Disease, Motor Symptoms, Akinesia
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Motor symptoms, Parkinson's Disease, Delayed Onset, Akinesia, Hypomobility, Unified Parkinson Disease Rating Scale (UPDRS) motor scores, Dopamine agonist, Apomorphine, Apokyn, Levodopa
Eligibility Criteria
Inclusion Criteria:
- Male or female ≥18 years of age.
- Idiopathic PD.
- Not currently taking APOKYN and, if previously prescribed APOKYN, did not discontinue therapy due to intolerable side effects/safety reasons.
- Prescribed L-dopa therapy at a steady maintenance dose, representing an optimal treatment regimen in the opinion of the Investigator, for at least 4 weeks before study participation.
- Minimum subject-reported time to turn "on" (TTO) in the early morning (time to end akinetic/ bradykinetic state resulting from delay in L-dopa onset of action) of 45 minutes after the first morning L-dopa dose for a minimum of 3 days/week (as determined with the subject diary at Visit 2).
- Able to adequately differentiate between and describe variations in "on" and "off" states in the opinion of the Investigator.
- I to III Modified Hoehn and Yahr stage in the "on" state (Appendix B).
- Be seeking treatment for early morning akinesia.
If female and of childbearing potential, must agree to use one of the following methods of birth control:
- Oral 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).
- Access to a live-in caregiver, if needed.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study-related procedures to complete the study.
Able to verbalize understanding of the consent form, able to provide written informed consent.
The following must be present for inclusion in the single site gastroparesis sub-study:
- Have symptoms of gastroparesis.
- Have improvement of at least one Modified Hoehn and Yahr stage from "off" to "on."
- Currently seeking treatment for delayed L-dopa onset.
- Have no allergy to eggs.
Exclusion Criteria:
- Changes in L-dopa dosing regimen 4 weeks before the screening visit.
- Female who is pregnant or lactating.
- Contraindications to APOKYN or hypersensitive to apomorphine hydrochloride or any of the ingredients of APOKYN (notably sodium metabisulfite).
- Participation in any other clinical trial within 14 days of the screening visit.
- Receipt of any investigational (i.e., unapproved) medication within 30 days of the screening visit.
- 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 taking medications for treatment of gastroparesis (e.g., erythromycin, cisapride, metoclopramide).
- Malignant melanoma or a history of previously treated malignant melanoma within 5 years.
Serious medical illness including, but not limited to:
- Liver disease;
- Kidney problems; and
- Heart problems.
- Psychiatric disorder, including but not limited to dementia or any disorder that, in the opinion of the Investigator requires ongoing treatment that would make study participation unsafe or make treatment compliance difficult.
- Lack of compliance and follow-up.
- Any other condition, current therapy, or prior therapy (within 30 days of the screening visit), which, in the opinion of the Investigator, would make the subject unsuitable for the study.
Sites / Locations
- Keck School of Medicine
- Neurosearch, Inc.
- Georgetown University
- Parkinson's Disease and Movement Disorders Center of Boca Raton
- Rush University Medical Center
- Henry Ford West Bloomfield Hospital
- Parkinson's Disease and Movement Disorders Center of New York
- University of Cincinnati Academic Health Center
- University Hospitals Case Medical Center
- The Movement Disorder Clinic of Oklahoma
- University of Texas Health Science Center, Houston, Department of Neurology
- Center for Neurological Care and Research
Arms of the Study
Arm 1
Experimental
APOKYN
APOKYN (apomorphine hydrochloride injection) is used as needed to treat off-episode motor symptoms, such as muscle stiffness, slow movements, and difficulty starting movements, in people with advanced Parkinson's disease (PD). In the study, subjects will complete an L-Dopa Baseline Period in which they record daily "time to on" following their regularly scheduled L-Dopa morning dose for 7 days. At the end of the baseline period, patients will start trimethobenzamide therapy during a minimum 3-Day Anti-Emetic Pretreatment Period. Patients determined to remain eligible at the end of the required Anti-Emetic Pretreatment Period will be initiated on APOKYN therapy by an investigator. Once the appropriate dose is identified by a study investigator, patients will inject APOKYN at their regularly scheduled levodopa morning dose time (levodopa will be delayed by 40 minutes) daily during a 7-day APOKYN Treatment Period and record "time to on" following the APOKYN injection.