An Open-Label Phase 3 Study to Examine the Long-Term Safety, Tolerability and Efficacy of APL-130277 for the Acute Treatment of "OFF" Episodes in Patients With Parkinson's Disease



Status:Recruiting
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:3/22/2019
Start Date:August 31, 2015
End Date:January 1, 2020
Contact:CNS Medical Director
Phone:1-866-503-6351

Use our guide to learn which trials are right for you!

An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients With Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)

An Open-Label Phase 3 Study to Examine the Long-Term Safety, Tolerability and Efficacy of
APL-130277 for the Acute Treatment of "OFF" Episodes in Patients With Parkinson's Disease


De Novo Subjects Inclusion Criteria

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)

3. Clinically meaningful response to L-Dopa as determined by the Investigator.

4. Receiving stable doses of L-Dopa/carbidopa (immediate or CR) administered at least 4
times per day OR Rytary™ administered at least 3 times per day, for at least 4 weeks
before the initial Screening Visit (SV1). Adjunctive PD medication regimens must be
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).

5. No planned medication change(s) or surgical intervention anticipated during the course
of study.

6. Subject must experience at least one well defined "OFF" episode per day with a total
daily "OFF" time duration of ≥ 2 hours during the waking day, based on patient
self-assessment.

7. Subject and/or caregiver must be trained in performing home dosing diary assessments
of the motor state and must be able to recognize "ON" and "OFF" states.

8. Stage III or less on the modified Hoehn and Yahr scale in the "ON" state.

9. MMSE score > 25.

10. If female and of childbearing potential, must agree to be sexually abstinent or use
one of the following highly effective methods of birth control:

- Hormonal contraceptives (eg, combined oral contraceptives, patch, vaginal ring,
injectables, and implants);

- Intrauterine contraceptive system;

- Surgical sterilization or partner sterile (must have documented proof); AND

One of the following effective methods of birth control:

- Male/female condom;

- Cervical cap with spermicide;

- Diaphragm with spermicide;

- Contraceptive sponge.

11. Male subjects must be either surgically sterile, agree to be sexually inactive or use
a double-barrier method of birth control (eg, condom and diaphragm with spermicide,
condom with cervical cap and spermicide) from first study drug administration until 90
days after final drug administration.

12. Willing and able to comply with scheduled visits, treatment plan, laboratory tests,
and other study-related procedures.

13. Able to understand the consent form, and to provide written informed consent.

De Novo Subjects Exclusion Criteria -

1. Atypical or secondary parkinsonism.

2. Previous treatment with any of the following: a neurosurgical procedure for PD;
continuous s.c. apomorphine infusion; Duodopa/Duopa; or APL-130277.

3. Treatment with any form of s.c. apomorphine within 7 days prior to the second
Screening Visit (SV2). Patients that stopped s.c. apomorphine for any reason other
than systemic safety concerns or lack of efficacy may be considered.

4. Contraindications to APOKYN®, or hypersensitivity to apomorphine hydrochloride or any
of the ingredients of APOKYN® (notably sodium metabisulfite).

5. Female who is pregnant or lactating.

6. Participation in a clinical trial within 30 days prior to the initial Screening Visit
(SV1).

7. Receipt of any investigational (ie, unapproved) medication within 30 days prior to the
initial Screening Visit (SV1).

8. Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron,
palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or
dopamine depleting agents.

9. Drug or alcohol dependency in the past 12 months.

10. Subject has a history of malignancy within 5 years prior to the Screening visit,
except for adequately treated basal cell or squamous cell skin cancer or in situ
cervical cancer. Pituitary tumors of any duration are excluded.

11. Clinically significant medical, surgical, or laboratory abnormality in the opinion of
the Investigator.

12. Major psychiatric disorder including, but not limited to, dementia, bipolar disorder,
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.

13. History of clinically significant hallucinations during the past 6 months.

14. History of clinically significant impulse control disorder(s).

15. Dementia that precludes providing informed consent or would interfere with
participation in the study.

16. Current suicidal ideation within one year prior to the second Screening Visit (SV2) as
evidenced by answering "yes" to Questions 4 or 5 on the suicidal ideation portion of
the C-SSRS or attempted suicide within the last 5 years.

17. Donation of blood or plasma in the 30 days prior to first dosing.

18. Presence of canker or mouth sores in the 30 days prior to the initial Screening Visit
(SV1), or other clinically significant oral pathology in the opinion of the
Investigator. The Investigator should follow-up with an appropriate specialist on any
finding, if indicated, before enrolling a patient into the study.

Rollover Subjects Inclusion Criteria

1. Completion of any of the following studies: CTH-201, CTH-203, CTH-300, or CTH 302;
and, in the opinion of the Investigator, would benefit from continued treatment with
APL 130277.

2. No major changes in concomitant PD medications since completion of any of the
following studies: CTH-201, CTH-203, CTH-300, or CTH 302. Any change in PD medications
since the previous study should be discussed with the Medical Monitor to determine
subject eligibility in the current study.

3. If female and of childbearing potential, must agree to be sexually abstinent or use
one of the following highly effective methods of birth control:

- Hormonal contraceptives (eg, combined oral contraceptives, patch, vaginal ring,
injectables, and implants);

- Intrauterine contraceptive system;

- Surgical sterilization or partner sterile (must have documented proof); AND

One of the following effective methods of birth control:

- Male/female condom;

- Cervical cap with spermicide;

- Diaphragm with spermicide;

- Contraceptive sponge.

4. Male subjects must be either surgically sterile, agree to be sexually inactive or use
a double-barrier method of birth control (eg, condom and diaphragm with spermicide,
condom with cervical cap and spermicide) from first study drug administration until 90
days after final drug administration.

5. Willing and able to comply with scheduled visits, treatment plan, laboratory tests,
and other study-related procedures.

6. Able to understand the consent form, and to provide written informed consent.

Rollover Subjects Exclusion Criteria

1. Female who is pregnant or lactating.

2. Presence of any major psychiatric disorder including, but not limited to, dementia,
bipolar disorder, psychosis (including clinically significant hallucinations during
the past 6 months) or any disorder that, in the opinion of the Investigator, requires
ongoing treatment that would make study participation unsafe or make treatment
compliance difficult.

3. Presence of any clinically significant medical (including but not limited to CNS,
cardiovascular, hepatic, pulmonary, metabolic, or renal events), surgical, or
laboratory abnormality that would make study participation unsafe or make treatment
compliance difficult. Clinical significance to be determined by the Investigator.

4. Receipt of any investigational (ie, unapproved) medication or participation in any
clinical trial of an investigational product since completing a previous study using
APL 130277.

5. Development of canker or mouth sores within 14 days of completing a previous study
using APL-130277. For other clinically significant oral pathology, the Investigator
should follow-up with an appropriate specialist on any finding, if indicated, before
enrolling such a subject into the study. Clinical significance to be determined by the
Investigator. The eligibility of subjects who have experienced AEs related to the oral
cavity during the previous study using APL-130277, should be reviewed with the medical
monitor and approval obtained.

6. Current suicidal ideation within one year of the screening visit, as evidenced by
answering "yes" to Question 4 or 5 on the suicidal ideation portion of the C SSRS at
Screening or attempted suicide within 5 years.

CTH-301 Completer Subjects Inclusion Criteria

1. Completion of the CTH-301 study under protocol version 3.00, and in the opinion of the
Investigator, would benefit from continued treatment with APL 130277.

2. If female and of childbearing potential, must agree to be sexually abstinent or use
one of the following highly effective methods of birth control:

- Hormonal contraceptives (eg, combined oral contraceptives, patch, vaginal ring,
injectables, and implants);

- Intrauterine contraceptive system;

- Surgical sterilization or partner sterile (must have documented proof); AND

One of the following effective methods of birth control:

- Male/female condom;

- Cervical cap with spermicide;

- Diaphragm with spermicide;

- Contraceptive sponge.

3. Male subjects must be either surgically sterile, agree to be sexually inactive or use
a double-barrier method of birth control (eg, condom and diaphragm with spermicide,
condom with cervical cap and spermicide) from first study drug administration until 90
days after final drug administration.

4. Willing and able to comply with scheduled visits, treatment plan, laboratory tests,
and other study-related procedures.

5. Able to understand the consent form, and to provide written informed consent.

CTH-301 Completer Subjects Exclusion Criteria

1. Female who is pregnant or lactating.

2. Presence of any major psychiatric disorder including, but not limited to, dementia,
bipolar disorder, psychosis (including clinically significant hallucinations during
the past 6 months) or any disorder that, in the opinion of the Investigator, requires
ongoing treatment that would make study participation in unsafe or make treatment
compliance difficult.

3. Presence of any clinically significant medical (including but not limited to CNS,
cardiovascular, hepatic, pulmonary, metabolic, or renal events), surgical, or
laboratory abnormality that would make study participation unsafe or make treatment
compliance difficult. Clinical significance to be determined by the Investigator.

4. Receipt of any investigational (ie, unapproved) medication or participation in any
clinical trial since completing the CTH 301 study.

5. Development of canker or mouth sores since completing the CTH 301 study. For other
clinically significant oral pathology, the Investigator should follow-up with an
appropriate specialist on any finding, if indicated, before enrolling such a patient
into the study. Clinical significance to be determined by the Investigator.

6. Current suicidal ideation as evidenced by answering "yes" to Question 4 or 5 on the
suicidal ideation portion of the C-SSRS at the Screening Visit Phase 2 (SVP2).
We found this trial at
52
sites
Atlanta, Georgia 30322
Phone: 404-712-6999
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Phone: 433-287-7850
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Phone: 205-934-0074
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Phone: 216-444-1179
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
Phone: 305-243-3647
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
?
mi
from
Miami, FL
Click here to add this to my saved trials
Augusta, Georgia 30912
Phone: 706-721-0619
?
mi
from
Augusta, GA
Click here to add this to my saved trials
Aurora, Colorado 80045
Phone: 303-724-4172
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Baltimore, Maryland 20742
(301) 405-1000
Phone: 443-827-0677
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Boca Raton, Florida 33486
Phone: 561-392-1818
?
mi
from
Boca Raton, FL
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Phone: 843-792-9115
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlottesville, Virginia 22903
Phone: 434-982-6599
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
303 East Superior Street
Chicago, Illinois 60611
Phone: 312-503-1999
?
mi
from
Chicago, IL
Click here to add this to my saved trials
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Phone: 312-942-8002
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Phone: 513-558-6517
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Phone: 614-688-8672
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Commack, New York 11725
Phone: 631-462-7774
?
mi
from
Commack, NY
Click here to add this to my saved trials
Durham, North Carolina 27705
Phone: 919-668-2905
?
mi
from
Durham, NC
Click here to add this to my saved trials
East Lansing, Michigan 48824
Phone: 517-884-2274
?
mi
from
East Lansing, MI
Click here to add this to my saved trials
Farmington Hills, Michigan 48334
Phone: 248-957-8940
?
mi
from
Farmington Hills, MI
Click here to add this to my saved trials
Fountain Valley, California 92708
Phone: 714-378-5074
?
mi
from
Fountain Valley, CA
Click here to add this to my saved trials
Glenview, Illinois 60026
Phone: 847-503-4322
?
mi
from
Glenview, IL
Click here to add this to my saved trials
Golden Valley, Minnesota 55427
Phone: 952-993-5903
?
mi
from
Golden Valley, MN
Click here to add this to my saved trials
Houston, Texas 77030
Phone: 713-363-8390
?
mi
from
Houston, TX
Click here to add this to my saved trials
Iowa city, Iowa 52242
Phone: 319-356-8744
?
mi
from
Iowa city, IA
Click here to add this to my saved trials
Irvine, California 92697
Phone: 949-824-1114
?
mi
from
Irvine, CA
Click here to add this to my saved trials
Kansas City, Kansas 66160
Phone: 913-588-6989
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
Kirkland, Washington 98034
Phone: 425-899-3115
?
mi
from
Kirkland, WA
Click here to add this to my saved trials
Lexington, Kentucky
859) 257-9000
Phone: 859-323-0028
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Los Angeles, California 90033
Phone: 323-442-5723
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
Oceanside, California
Phone: 760-732-0557
?
mi
from
Oceanside, CA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19107
Phone: 215-503-3213
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19107
Phone: 215-829-7128
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Port Charlotte, Florida 33980
Phone: 941-743-4987
?
mi
from
Port Charlotte, FL
Click here to add this to my saved trials
Raleigh, North Carolina 27607
Phone: 919-719-8826
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Saint Petersburg, Florida 33713
Phone: 727-202-2623
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
Scottsdale, Arizona 85258
Phone: 480-526-5441
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Phone: 480-301-4750
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
Seattle, Washington 98122
Phone: 206-320-7121
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Tampa, Florida 33613
Phone: 813-396-0763
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Toledo, Ohio 43614
Phone: 419-383-6728
?
mi
from
Toledo, OH
Click here to add this to my saved trials
Toronto, Ontario
Phone: 416 603 5800
?
mi
from
Toronto,
Click here to add this to my saved trials
Traverse City, Michigan 49684
Phone: 231-935-0340
?
mi
from
Traverse City, MI
Click here to add this to my saved trials
Tulsa, Oklahoma 74136
Phone: 918-392-4530
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
Tyler, Texas 75701
Phone: 903-531-8850
?
mi
from
Tyler, TX
Click here to add this to my saved trials
Virginia Beach, Virginia 23456
Phone: 757-507-0642
?
mi
from
Virginia Beach, VA
Click here to add this to my saved trials
Washington, District of Columbia 20007
Phone: 202-444-6941
?
mi
from
Washington,
Click here to add this to my saved trials
West Bloomfield, Michigan 48322
Phone: 248-661-6270
?
mi
from
West Bloomfield, MI
Click here to add this to my saved trials
?
mi
from
Winfield, IL
Click here to add this to my saved trials
Winston-Salem, North Carolina 27157
Phone: 336-716-8694
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials