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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 21 August 2023
Main ID:  NCT01770145
Date of registration: 07/01/2013
Prospective Registration: No
Primary sponsor: MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals
Public title: Apokyn for Motor IMProvement of Morning AKinesia Trial (AM IMPAKT) AM IMPAKT
Scientific title: 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
Date of first enrolment: December 2012
Target sample size: 127
Recruitment status: Completed
URL:  https://clinicaltrials.gov/ct2/show/NCT01770145
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
United States
Contacts
Name:     Gianpiera H. Ceresoli-Borroni, PhD
Address: 
Telephone:
Email:
Affiliation:  Supernus Pharmaceuticals
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Delayed Levodopa Onset
Hypomobility
Parkinson's Disease
Akinesia
Motor Symptoms
Intervention(s)
Drug: L-dopa
Drug: APOKYN
Drug: Trimethobenzamide
Primary Outcome(s)
Change From Baseline in Average Daily "Time to on" ("TTO") by Subject Diary. [Time Frame: L-Dopa Baseline Days 1-7 and APOKYN Treatment Days 1-7]
Secondary Outcome(s)
Change From Baseline in Gastric Emptying Time [Time Frame: L-Dopa Baseline Days 1-7 and APOKYN Treatment Days 1-8]
Secondary ID(s)
USWM-AP1-4001
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 07/09/2015
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01770145
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