PHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITHMOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASE

Phase 1

• Conditions: MedDRA version: 20.0Level: LLTClassification code 10013113Term: Disease Parkinson'sSystem Organ Class: 100000014025; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]; Parkinson’s disease

• Registration Number: EUCTR2017-000128-81-DE
• Lead Sponsor: Pfizer Inc., 235 East 42nd Street, New York, New York

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-06
• Last Update Posted: 5 June 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
1. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study at Screening.
2. Subjects must have successfully completed the B7601003 study through Wk 15,continue to meet all safety criteria at Screening and through Randomization visit, and must be considered compliant in the opinion of the investigator and the Sponsor.
3. No change since B7601003 study in any significant medical, rheumatologic, oncologic, neurologic, psychiatric or surgical conditions that are deemed to increase risk for participation in the extension study.
4. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures, including Parkinson’s disease diary.
5. Subjects are willing and able to continue to refrain from any medication not permitted by the protocol throughout participation in the study.
6. Subjects successfully completed study B7601003 through Wk 15, with an IP dosing gap of no more than 60 days between the 2 studies.
7. Females of non-childbearing potential and/or male subjects between the ages of 40 and 87 years, inclusive. Male subjects able to father children must agree to use 1 highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment.
Female subjects of non-childbearing potential must meet at least 1 of the following criteria:
Have undergone a documented hysterectomy and/or bilateral oophorectomy;
Have medically confirmed ovarian failure; or
Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle-stimulating hormone (FSH) level confirming the post-menopausal state.
All other female subjects (including females with tubal ligations) will be considered to be of childbearing potential and are not eligible for participation.
8. Subjects must still be able to recognize their wearing off” symptoms and confirm that they usually improve after their next dose of PD medication.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

Subjects with any of the following characteristics/conditions will not be included in the study:
Concomitant Medications:
1.Currently receiving an antipsychotic, metoclopramide, reserpine, or amphetamine.
2.Currently receiving moderate or strong CYP3A4 inducers or CYP3A4 inhibitors (except for topical administration).
3.Previous implantation of apomorphine pump, or surgery for intraduodenal use of Duodopa.
4.Dopamine receptor agonist medications including pramipexole, ropinirole, rotigotine and apomorphine taken within 60 days prior to Day - 1.
5.Herbal supplements taken within 28 days prior to Day -1 (Herbal supplements defined as concentrated/manufactured capsules or tablets).
6.Prohibited concomitant medications as outlined in Section 5.8, Concomitant Treatment(s) and in the Prohibited Concomitant Medication List.
Screening Assessments:
7. 12-lead ECG (average of triplicate measures) demonstrating QTcF >450 msec (>470 msec for females) or a QRS interval >120 msec at Screening.
General and Administrative:
8. Subjects who would have a gap of more than 60 days between their last IP dose in Study B7601003 and their first dose in Study B7601017.
9. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
10. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to Day-1.
11. Unwilling or unable to comply with the lifestyle requirements described in the protocol.
Medical History:
12. Emergence of severe acute or chronic medical condition, or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Screening Assessments:
13. Females of childbearing potential assessed at Screening; Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; fertile male subjects who are unwilling or unable to use 1 highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
14. Finding of suicidal ideation associated with actual intent and/or plan in the past year; (a YES” answer to C-SSRS questions 4 some intent to act without specific plan” or 5 specific plan and intent”) not cleared by a mental health professional evaluation.
15. Screening supine blood pressure =160 mm Hg (systolic) or =95 mm Hg (diastolic), on a single measurement. If abnormal, up to 2 repeats are permitted following at least 5 minutes of rest. The screening value in that case will be the average of the 2 values closest to the normal range.
16. A decrease in systolic blood pressure (BP) of >20 mmHg or in diastolic BP of >10 mmHg measured 2 minutes after changing from a supine to standing position in the presence of symptoms of orthostasis. In the absence of symptoms of orthostasis a decrease in systolic blood pressure (BP) of >30 mmHg or in diastolic BP of >15 mmHg measured 2 minutes after changing from a supine to stan

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified