A 15-WEEK CLINICAL STUDY TO DETERMINE THEEFFECTIVENESS, SAFETY AND TOLERABILITY OF PF-06649751 IN PATIENTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASE

Phase 1

• Conditions: Parkinson's Disease; MedDRA version: 20.0Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-004912-39-DE
• Lead Sponsor: Pfizer, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-11
• Last Update Posted: 11 June 2018

Recruitment & Eligibility

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

Inclusion Criteria

- Clinical diagnosis of Parkinson’s disease consistent with the United Kingdom (UK) Parkinson’s Disease Society Brain Bank Clinical Diagnostic Criteria.
- Parkinson’s disease Hoehn & Yahr Stage less than or equal to III while the subject is ON.
- Currently responding to L-Dopa therapy.
- Total duration of 2.5 hours OFF time each day, based on the OFF time diary (Hauser diary) collected over 3 consecutive days during the screening period (with fewer than 4 errors or missing entries in diary data per day) and at least 75% concordance with investigator for Screening ON/OFF time concordance testing (see Concordance Testing and OFF Time Diary Training).
- Subjects must be able to recognize their wearing off” symptoms and confirm that they usually improve after their next dose of Parkinson’s disease medication.
- On a stable dose of L-Dopa of at least 400 mg total daily dose for at least 28 days prior to Day 0 (Randomization), in conjunction with a dopa-decarboxylase inhibitor (eg, L-Dopa/carbidopa or L-Dopa/benserazide) divided in at least 4 doses per day. Subjects on a stable dose of L-Dopa of at least 400 mg/day divided into 3 daily doses (TID) may be considered and authorized on a case-by-case basis if submitted as part of the screening assessment to the sponsor and/or its designee for determination if the dosing regimen is considered optimized
for that particular subject. No subject on TID dosing will be considered eligible for Randomization without this additional eligibility assessment.
- Willing and able to refrain from any Parkinson’s disease medication not permitted by the protocol throughout participation in the study.
- Body Mass Index (BMI) of 17.5 to 35 kg/m2; and a total body weight 45 kg.
- A score of 26 on the Mini Mental State Examination (MMSE).
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 99
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 99

Exclusion Criteria

- History or clinical features consistent with an atypical Parkinsonian syndrome.
- History of surgical intervention for Parkinson’s disease (pallidotomy, thalamotomy, deep brain stimulation, etc).
- A score of 4 on item 4.2 Functional Impact of Dyskinesias of MDS-UPDRS Part IV (motor complications) at Screening.
- Psychotic symptoms related to Parkinson’s disease requiring treatment with an antipsychotic medication within 6 months prior to Screening.
- Any Parkinson’s disease-related feature or symptom that could interfere with the study conduct and results as assessed by the sponsor or Investigator.
- Severe acute or chronic medical, including fever, or psychiatric condition 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.
- 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), including childhood seizures, or conditions that lower seizure threshold, seizures of any etiology (including substance or drug
withdrawal), or known increased risk of seizures.
- A 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) that in the opinion of the investigator could interfere with study participation or poses a risk to the subject. Presence of minor depression or treated, stable depressive disorder is acceptable.
- History of clinically significant alcohol or substance dependency (other than caffeine or nicotine), as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), within 1 year before Screening.
- 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.
- Any condition possibly affecting drug absorption, past surgery of the gastrointestinal tract (eg, gastrectomy, colectomy), except cholecystectomy.
- History of vasculitis.
- History of Human immunodeficiency virus (HIV) infection.
- 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.
- Subjects with first degree family history of unexplained sudden death, or of Long QT syndrome (LQTS).
- Currently receiving an antipsychotic, metoclopramide, reserpine, or amphetamine.
- Currently receiving moderate or strong CYP3A4 inducers or CYP3A4 inhibitors (except for topical administration).
- Previous implantation of apomorphine pump, or surgery for intraduodenal use of Duodopa.
-Dopamine receptor agonist medications including pramipexole, ropinirole, rotigotine and apomorphine must be discontinued at least 28
days prior to Day 0 (Randomization).
-Herbal supplements must be discontinued at least 28 days prior to Day 0 (Randomization).

Study & Design

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