|- candidate number||26670|
|- NTR Number||NTR6241|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||9-feb-2017|
|- Secondary IDs||163037 METC azM/UM|
|- Public Title||Examining the pharmacokinetic and pharmacodynamic profile of biperiden|
|- Scientific Title||Examining the pharmacokinetic and pharmacodynamic profile of biperiden
|- ACRONYM||PK/PD biperiden|
|- Healt Condition(s) or Problem(s) studied||Pharmacodynamics, Pharmacokinetics|
|- Inclusion criteria||• In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.|
• The participant has a body mass index of 18.5-30 kg/m2, inclusive, at medical screening.
• The participant is aged 18 to 35 years, inclusive, at the time of informed consent.
• The volunteer is healthy, i.e. absence of all exclusion criteria and had normal or corrected to normal static binocular acuity with or without correction.
• The participant signs and dates a written informed consent form before the start of the experiments.
|- Exclusion criteria||• The subject has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality which may impact the ability of the subject to participate or potentially confound the study results. |
• The volunteer has uncontrolled existing major psychiatric symptoms.
• The participant has known hypersensitivity to any component of the formulation or biperiden or related compounds.
• The subject has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the first visit or is unwilling to agree to abstain from alcohol from 24 hours prior to each test day and/or drugs throughout the study.
• The participant has any sensory or motor deficits which could reasonably be expected to affect test performance.
• Other exclusion criteria are smoking, excessive drinking (>20 glasses of alcohol containing beverages a week), pregnancy or lactation, use of medication other than oral contraceptives.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2017|
|- planned closingdate|
|- Target number of participants||27|
|- Interventions||Subjects will participate in 3 treatment conditions: i.e. placebo, biperiden 2 mg and 4 mg. All medications will be administered orally. Order of treatments will be balanced over three test sessions, which will be separated by a washout period of at least 7 days.|
|- Primary outcome||The main endpoints for the cognitive tasks are the behavioral score on the immediate and delayed recall of the VLT. This includes the number of words recalled immediately and after a 20 minute delay.|
|- Secondary outcome||Secondary, to establish the pharmacokinetic and pharmacodynamics profile of biperiden the primary endpoints will be the blood serum values and physiological measures (body temperature, blood pressure, heart rate and pupil size). Furthermore the behavioral outcomes of the n-back and simple and choice reaction tasks will be used for analysis, as well as the scores on the B&L and complaints questionnaire. Next to this, the event-related potentials during the behavioural tasks will be analysed. Another important measure is the brain response to the novelty oddball task, which will give an indication of the role of acetylcholine in novelty processing.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Laura Borghans|
|- CONTACT for SCIENTIFIC QUERIES|| Anke Sambeth|
|- Sponsor/Initiator ||Maastricht University|
(Source(s) of Monetary or Material Support)
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||9-feb-2017 - 29-apr-2017|