Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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10 December 2019 |
Main ID: |
EUCTR2007-003035-22-PT |
Date of registration:
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01/07/2008 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A safety and tolerability study of ACP-103 in patients with Parkinson's Disease Psychosis
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Scientific title:
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A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease |
Date of first enrolment:
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09/01/2009 |
Target sample size:
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400 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-003035-22 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Austria
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Belgium
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Canada
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European Union
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France
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India
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Italy
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Portugal
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Russian Federation
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Sweden
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Hugh Diep
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Address:
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100 Alexis-Nihon, Suite 800
H4M 2P4
Saint-Laurent (Montréal), Québec
Canada |
Telephone:
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+1 514 855 5560 |
Email:
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hugh.diep@quintiles.com |
Affiliation:
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Quintiles Transnational Corp |
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Name:
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Hugh Diep
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Address:
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100 Alexis-Nihon, Suite 800
H4M 2P4
Saint-Laurent (Montréal), Québec
Canada |
Telephone:
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+1 514 855 5560 |
Email:
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hugh.diep@quintiles.com |
Affiliation:
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Quintiles Transnational Corp |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Subject has completed the blinded treatment period of a previous study of pimavanserin in PDP within the last 28 days and, who may, in the opinion of the Investigator, benefit from therapy with pimavanserin
2. Subject must have clear sensorium at study entry (i.e., oriented to time, person, and place) and thus not be delirious
3. Female subjects must be of non-childbearing potential (defined as either surgically sterilized or at least 1 year post-menopausal) or must agree to use a clinically acceptable method of contraception (such as intrauterine device [IUD], diaphragm, or oral, injectable [e.g. Depo-Provera] or implantable contraception [e.g. Norplant? System]) during the study and one month following completion of the study
4. The subject is willing and able to provide consent
5. Caregiver is willing and able to provide consent and agrees to accompany the subject to all visits
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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 350
Exclusion criteria: 1. Subject 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 and or unstable gastrointestinal, hematologic or other medical disorder
2. Subject is using any of the medications prohibited or restricted as described in Appendix 1 (Prohibited and Restricted Concomitant Medications
3. Subject is on medications known to prolong the QT interval (as described in Appendix 1)
4. Subject has a baseline electrocardiogram (ECG) with Bazett’s corrected QT (QTcB) of greater than 460 msec if male or 470 msec if female
5. Subject had an allergy or sensitivity to pimavanserin based on known allergies to drugs of the same class
6. Subject is judged by the Investigator to be inappropriate for the study
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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MedDRA version: 18.0
Level: LLT
Classification code 10037241
Term: Psychosis NOS
System Organ Class: 100000004873
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Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
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Intervention(s)
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Product Name: Pimavanserin tartrate Product Code: pimavanserin (ACP-103) Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Pimavanserin tartrate CAS Number: 706782-28-7 Current Sponsor code: pimavanserin (ACP-103) Other descriptive name: N/A Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20-
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Primary Outcome(s)
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Main Objective: To assess long-term safety and tolerability of pimavanserin in subjects with Parkinson’s Disease Psychosis (PDP)
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Primary end point(s): Safety: • The safety of subjects will be assessed by monitoring adverse events, physical examinations, vital signs, clinical laboratory tests (hematology, clinical chemistry, and urinalysis) and ECGs.
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Timepoint(s) of evaluation of this end point: Baseline, Week 2, Month 1, Month 3, Month 6, Month 9, Month 12 and every 6 months thereafter
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Secondary Objective: Not applicable
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Not applicable
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Secondary end point(s): Not Applicable
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Secondary ID(s)
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2007-003035-22-GB
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N/A
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ACP-103-015
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NCT00550238
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Source(s) of Monetary Support
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ACADIA Pharmaceuticals Inc.
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Ethics review
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Status: Approved
Approval date:
Contact:
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