| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
|
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 9.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10061536 |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| Primary Efficacy Objective: The Primary Efficacy Objective of this trial is to evaluate the efficacy of a range of preladenant doses compared with placebo in subjects with early Parkinson’s disease (PD) as measured by the sum of UPDRS Parts 2 and 3 scores (UPDRS2+3). Primary Safety Objective: The Primary Safety Objective of this trial is to evaluate the safety and tolerability of preladenant compared with placebo in subjects with early PD. |
|
| E.2.2 | Secondary objectives of the trial |
| Key Secondary Trial Objective: The Key Secondary Objective of this trial is to evaluate the efficacy of a range of preladenant doses compared with placebo in subjects with early PD as measured by the proportion of Responders and by the UPDRS Part 2 score. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
| Inclusion Criteria: -Each subject must have a diagnosis of idiopathic PD based on the following criteria: a. Each subject should have bradykinesia and at least one of the following symptoms: i. Muscular rigidity ii. Resting tremor (4 to 6 Hz) iii. Postural instability (impairment of postural reflexes, eg, as assessed by the pull test) unrelated to primary visual, cerebellar, vestibular, or proprioceptive dysfunction b. If resting tremor is not present at screening, the rigidity and/or bradykinesia must be asymmetric. Each subject who is receiving amantadine and/or anticholinergics must have been on a stable regimen of treatment for at least the 4 weeks immediately before Screening. (Note: Subjects who are not taking any medications for PD are permitted to enroll in this trial.) Each subject must have a UPDRS Part 3 score of > or =10. Each subject’s Hoehn and Yahr Stage must be < or =3. Each subject must be willing and able to provide written informed consent for the trial. For a subject who is unable to provide independent consent, a legal representative may provide written informed consent. Subjects who are unwilling to provide written informed consent for exploratory pharmacogenetic testing may be included in the trial; however, exploratory pharmacogenetic samples must not be obtained. Each subject must be > or =30 to > or =85 years of age. A subject may be of either gender and any race/ethnicity. Each subject must have results of Screening clinical laboratory tests (hematology, blood chemistries, and urinalysis) drawn within 3 weeks prior to Randomization, clinically acceptable to the investigator, and not within the parameters specified for exclusion (below). Patient is either a male or: a. A female of reproductive potential and agrees to use (or have their partner use) one of the listed highly effective methods of birth control within the projected duration of the study: intrauterine device (IUD), condoms, diaphragm, vasectomy. The use of barrier contraceptive (condom or diaphragm) should always be supplemented with the use of a spermicide. Patients taking hormonal contraceptives may continue to use them during the trial, but must use 1 additional form of highly effective non-hormonal contraception throughout the study period. OR b. A female not of reproductive potential. A female patient who is not of reproductive potential is defined as: One who has either (1) reached natural menopause defined as at least 46 years old with (a) 12 months spontaneous amenorrhea or (b) 6 months of spontaneous amenorrhea with serum follicle stimulating hormone [FSH] levels in the postmenopausal range [> 40 IU/L] as determined by the central laboratory, (2) 6 weeks post surgical bilateral oophorectomy, (3) hysterectomy, or (4) bilateral tubal ligation. |
|
| E.4 | Principal exclusion criteria |
A subject must not have a form of drug-induced or atypical parkinsonism, cognitive impairment (ie, Montreal Cognitive Assessment [MoCA] score <26), bipolar disorder, schizophrenia, or other psychotic disorder. A subject must not have a history of repeated strokes with stepwise progression, repeated head injury, encephalitis and/or oculogyric crises on no drug treatment. A subject must not have experienced a stroke within 6 months of Screening or have a persistent neurological deficit that may interfere with study assessments. A subject must not have definite encephalitis, strictly unilateral features 3 years after being diagnosed with PD, other neurological features such as supranuclear gaze palsy, cerebellar signs, a Babinski sign with clear, clinically significant pyramidal tract involvement, frequent falls, hallucinations unrelated to medications, or presence of cerebral tumor or communicating hydrocephalus on neuroimaging (by history). A subject must not have severe, symptomatic autonomic involvement unrelated to medications. A subject must not have exposure to a known neurotoxin. A subject must not have a history of sustained remission of their Parkinson’s symptoms. A subject must not have failed to show a therapeutic response if a diagnostic levodopa (L-dopa) challenge had been done with a large test dose (>500 mg) of L-dopa (if malabsorption excluded). A subject must not have been treated with L-dopa or dopamine agonists for other than diagnostic purposes. If a subject has received L-dopa or dopamine agonists for diagnostic purposes, he/she must not have received the L-dopa or dopamine agonist within 30 days before Screening. A subject must not have an untreated major depressive disorder meeting Diagnostic and Statistical Manual of Mental Disorders IV Text Revision criteria. (A subject who is successfully treated [Beck Depression Inventory, Version II {BDI-II} score <19] with stable doses of allowed antidepressant medications for at least the 4 weeks immediately before Screening is eligible to enroll in the trial.) A subject must not be at imminent risk of self-harm or harm to others, in the investigator’s opinion based on clinical interview and responses provided on the Columbia Suicide Severity Rating Scale (CSSRS). Subjects must be excluded if they report suicidal ideation of Type 4 or 5 in the past 2 months or suicidal behavior in the past 6 months as measured by the CSSRS at Screening or Baseline. Blood Pressure: A subject must not have a systolic blood pressure (BP) >or=150 mm Hg OR diastolic BP >or=100 mm Hg at Screening and at a BP recheck prior to Randomization. Should the BP remain elevated, the subject may not enter the trial until the BP has been adequately controlled as demonstrated by 2 BP measurements meeting this criterion at consecutive separate visits within 3 weeks prior to Randomization. Subjects may be on stable antihypertensive medication.
-Cardiovascular Disease: A subject must not have had any clinically significant cardiovascular event or procedure for 6 months prior to Randomization. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| The Primary Efficacy Endpoint for this trial is the change from Baseline to Week 26 (End of Part 1 Treatment) in the sum of UPDRS Parts 2 and 3 scores (UPDRS2+3). |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | Yes |
| E.6.10 | Pharmacogenetic | Yes |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 50 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
| E.8.7 | Trial has a data monitoring committee | Yes |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| Lo studio avra` termine quando l`ultimo soggetto rimasto ha terminato la sua partecipazione nello studio, completandolo, uscendo prematuramente o non essendosi presentato per il follow up. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 2 |
| E.8.9.1 | In the Member State concerned months | 6 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 2 |
| E.8.9.2 | In all countries concerned by the trial months | 6 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
Print
