Clinical trial
A Phase 4, Open-Label, Efficacy and Safety Study of Apokyn® for Rapid and Reliable Improvement of Motor Symptoms in Parkinson Disease Subjects With Delayed Onset of L-Dopa Action
Name
USWM-AP1-4001
Description
This study is designed to assess the effect of APOKYN treatment in rapid and reliable improvement of motor symptoms in Parkinson's disease (PD) subjects suffering from delayed or unreliable onset of levodopa (L-dopa) action.
Trial arms
Trial start
2012-12-01
Estimated PCD
2014-04-01
Trial end
2014-04-01
Status
Completed
Phase
Early phase I
Treatment
APOKYN
Apokyn will be titrated to an optimum dose which reproduces 90% of the subjects' "best on" UPDRS score during the Initiation Period. During the APOKYN Treatment Period, subjects will inject the dose identified in the initiation period once daily at the time of their normal scheduled L-Dopa dose (L-Dopa will be delayed by 40 minutes).
Arms:
APOKYN
Other names:
apomorphine hydrochloride injection
L-dopa
Subjects on a stable L-Dopa regimen will be entered into the study. For the L-Dopa Baseline Period through the Initiation Period, subjects will continue their normal L-Dopa dosing regimen. During the APOKYN Treatment Period, subjects will replace their normally scheduled first morning L-Dopa dose with an APOKYN injection, and then administer their normal first morning L-Dopa dose 40 minutes later.
Arms:
APOKYN
Other names:
Levodopa, Levodopa/Carbidopa, Sinemet, Sinemet CR, Parcopa
Trimethobenzamide
Following the L-Dopa Baseline Period, subjects will initiate trimethobenzamide treatment TID for a minimum of 3 days during a Anti-Emetic Pretreatment Period. Subjects will continue trimethobenzamide therapy TID through the duration of the APOKYN Initiation Period and APOKYN Treatment Period.
Arms:
APOKYN
Other names:
Tigan
Size
127
Primary endpoint
Change From Baseline in Average Daily "Time to on" ("TTO") by Subject Diary.
L-Dopa Baseline Days 1-7 and APOKYN Treatment Days 1-7
Eligibility criteria
Inclusion Criteria:
1. Male or female ≥18 years of age.
2. Idiopathic PD.
3. Not currently taking APOKYN and, if previously prescribed APOKYN, did not discontinue therapy due to intolerable side effects/safety reasons.
4. 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.
5. 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).
6. Able to adequately differentiate between and describe variations in "on" and "off" states in the opinion of the Investigator.
7. I to III Modified Hoehn and Yahr stage in the "on" state (Appendix B).
8. Be seeking treatment for early morning akinesia.
9. 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).
10. Access to a live-in caregiver, if needed.
11. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study-related procedures to complete the study.
12. 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:
13. Have symptoms of gastroparesis.
14. Have improvement of at least one Modified Hoehn and Yahr stage from "off" to "on."
15. Currently seeking treatment for delayed L-dopa onset.
16. Have no allergy to eggs.
Exclusion Criteria:
1. Changes in L-dopa dosing regimen 4 weeks before the screening visit.
2. Female who is pregnant or lactating.
3. Contraindications to APOKYN or hypersensitive to apomorphine hydrochloride or any of the ingredients of APOKYN (notably sodium metabisulfite).
4. Participation in any other clinical trial within 14 days of the screening visit.
5. Receipt of any investigational (i.e., unapproved) medication within 30 days of the screening visit.
6. 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).
7. Currently taking medications for treatment of gastroparesis (e.g., erythromycin, cisapride, metoclopramide).
8. Malignant melanoma or a history of previously treated malignant melanoma within 5 years.
9. Serious medical illness including, but not limited to:
* Liver disease;
* Kidney problems; and
* Heart problems.
10. 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.
11. Lack of compliance and follow-up.
12. 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 127, 'type': 'ACTUAL'}}
Updated at
2023-08-14
1 organization
Organization
MDD US Operations