E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | |
E.1.1.1 | Medical condition in easily understood language |
Psychosis in Parkinson's Disease |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037241 |
E.1.2 | Term | Psychosis NOS |
E.1.2 | System Organ Class | 100000004873 |
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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 |
The purpose of this study is to explore the safety and tolerability of pimavanserin in patients with PDP. |
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E.2.2 | Secondary objectives of the trial |
• To explore the safety and tolerability of continued pimavanserin treatment in patients with PDP who have previously received long-term pimavanserin treatment for their symptoms.
• To explore the efficacy of continued pimavanserin treatment in patients with PDP who have previously received long-term pimavanserin treatment for their symptoms. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. The patient is participating in the ACP-103-015 study, and may, in the opinion of the Investigator, benefit from continued therapy with pimavanserin.
2. Patient is willing and able to provide informed consent. If the patient is unable to provide written consent, consent must be given by a legally authorized representative (LAR).
3. Female patients must be of non-childbearing potential (defined as either surgically sterilized or at least 1 year post-menopausal) or must agree to use a highly effective method of contraception (such as intrauterine device, diaphragm, or oral, or injectable
[e.g., Depo-Provera] or implantable contraception [e.g., Norplant® System]) during the study and 1 month following completion of the study. |
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E.4 | Principal exclusion criteria |
1. Patient has current evidence of a clinically significant concurrent medical illness including: severe cardiac disease (recent myocardial infarction, congestive heart failure or cardiac syncope), severe pulmonary disease (chronic obstructive pulmonary disease or emphysema), renal insufficiency or failure, hepatitis, a recent diagnosis of malignancy (excluding basal or squamous cell carcinoma), a serious or unstable gastrointestinal, hematologic, or other medical disorder, which in the opinion of the Investigator, may prevent them from participating in the study.
2. Use of any of the medications prohibited or restricted as described in Section 5.3.1 and Appendix 2 of the Protocol.
3. Use of medications known to prolong the QT interval (as described in Appendix 2).
4. Electrocardiogram (ECG) with Fridericia corrected QT interval (QTcF) of >460 msec.
5. Clinically significant laboratory abnormalities that in the judgment of the Investigator would jeopardize the safe conduct of the study.
6. Pregnant or breastfeeding patients. Female patients of child-bearing potential must have a negative pregnancy test at Baseline confirmed using a dipstick urine pregnancy test.
7. Likely to have an allergy or sensitivity to pimavanserin based on known allergies to drugs of the same class.
8. Has any condition that would interfere with the ability to comply with the study instructions or might confound the interpretation of the study results or put the subject at undue risk (in the opinion of the investigator). |
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E.5 End points |
E.5.1 | Primary end point(s) |
No statistical analyses will be performed for this study. Data will be reported in listings for each patient and in narratives for SAEs/deaths. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
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 | No |
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 |
France |
Portugal |
Russian Federation |
Serbia |
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E.8.7 | Trial has a data monitoring committee | No |
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
|
The end of the study is defined as "the last visit of the last patient undergoing the study". |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |