A 15-WEEK CLINICAL STUDY TO DETERMINE THE EFFECTIVENESS, SAFETY AND TOLERABILITY OF PF-06649751 IN PATIENTS WITH EARLY PARKINSON’S DISEASE

Phase 1

• Conditions: Parkinson's Disease; MedDRA version: 19.1Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-001575-71-ES
• Lead Sponsor: Pfizer, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-17
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

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.
2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
3. Females of non childbearing potential and/or male subjects between the ages of 45 and 80 years, inclusive.
4. Male subjects able to father children must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment.
5. Female subjects of non childbearing potential (ie, 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.
6. Clinical diagnosis of Parkinson’s disease consistent with the United Kingdom (UK) Parkinson’s Disease Society Brain Bank Clinical Diagnostic Criteria (Appendix 4).
7. Parkinson’s Disease Hoehn & Yahr Stage I III inclusive.
8. Parkinson’s disease subjects deemed appropriate for treatment of motor symptoms with a MDS UPDRS Part III score >=10.
9. Treatment naïve or history of prior incidental treatment with dopaminergic agents (including L Dopa and dopamine receptor agonist medications) for no more than 28 days and not within at least 7 days prior to Visit 1 (Randomization) as outlined in Section 5.8, Concomitant Treatment(s), and Appendix 2 in the protocol.
10. Willing and able to refrain from any Parkinson’s disease medication not permitted by the protocol (including dopaminergic agents) throughout participation in the study as outlined in Appendix 2 in the protocol.
11. A score of >=26 on the Mini Mental State Examination (MMSE).
12. Body Mass Index (BMI) of 17.5 to 35 kg/m2; and a total body weight >= 45 kg.
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 53
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

Exclusion Criteria

1. History or clinical features consistent with an atypical Parkinsonian syndrome (including but not limited to Progressive Supranuclear Palsy, Multiple System Atrophy, Cortico Basal Degeneration, etc).
2. Any Parkinson’s disease related feature or symptom that could interfere with the study conduct and results as assessed by the sponsor or Investigator.
3. Presence of acute or chronic clinically significant medical, including fever, or psychiatric condition or cognitive impairment 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.
4. Presence or history of brain tumor, past history of hospitalization for head trauma with loss of consciousness, epilepsy (as defined by the International League Against Epilepsy)E31, including childhood seizures, or conditions that lower seizure threshold, seizures of any etiology (including substance or drug withdrawal), or known increased risk of seizures.
5. Any significant AXIS I psychiatric disease as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition Revised (DSM IV TR, American Psychiatric Association, 2000) including subjects with clinically significant depression (PHQ 8 total score >=15) (refer to Section 7.1.6 of the protocol, Depression Assessment (PHQ 8). Presence of minor depression or treated, stable depressive disorder is acceptable.
6. Subjects who have made a suicide attempt within the last 5 years. Subjects who, in the investigator’s judgment, pose a significant suicide risk. Subjects who have suicidal ideation associated with actual intent and a method or plan in the past 6 months (ie, Yes” answers on items 4 or 5 of the C-SSRS; refer to Section 7.3 Assessment of Suicidal Ideation and Behavior (C-SSRS).
7. History of clinically significant alcohol or substance dependency (other than caffeine or nicotine), as defined in DSM IV TR, within 1 year before Screening.
8. In the opinion of the investigator (or caregiver, as applicable), has signs/symptoms suggestive of clinically significant cognitive impairment that would interfere with the ability to comply with study procedures.
9. Any condition possibly affecting drug absorption, past surgery of the gastrointestinal tract (eg, gastrectomy, colectomy), except cholecystectomy.
10. History of vasculitis.
11. History of Human Immunodeficiency Virus (HIV) infection.
12. History of malignancy other than:
• Non-metastatic basal or squamous cell carcinoma of the skin or carcinoma in situ that was surgically removed in total >1 year before screening and has not recurred.
• Other type of malignancy which has been in remission 5 years or more before screening and has not recurred.
13. Subjects with first degree family history of unexplained sudden death, or of Long QT syndrome (LQTS).
14. Within 1 year of Screening or between Screening and Visit 1 (Randomization), any of the following: myocardial infarction; moderate or severe congestive heart failure, NYHA class III or IV; hospitalization for, or symptoms of, unstable angina; syncope due to orthostatic hypotension or unexplained syncope; known significant structural heart disease (eg, significant valvular disease, hypertrophic cardiomyopathy); or hospitalization for arrhythmia.
15. Currently receiving moderate or str

Study & Design

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