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    Summary
    EudraCT Number:2016-002392-10
    Sponsor's Protocol Code Number:S59302
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-12-08
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2016-002392-10
    A.3Full title of the trial
    Reconsolidation interference versus retrieval interference as the basis for experimental amnesia in humans – The effect of drug state at memory retrieval
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Reconsolidation interference versus retrieval interference as the basis for experimental amnesia in humans – The effect of drug state at memory retrieval
    A.3.2Name or abbreviated title of the trial where available
    WipeOutFear_State
    A.4.1Sponsor's protocol code numberS59302
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUZ Leuven
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportERC
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKU Leuven
    B.5.2Functional name of contact pointPI Tom Beckers
    B.5.3 Address:
    B.5.3.1Street AddressTiensestraat 102 bus 3712
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3000
    B.5.3.4CountryBelgium
    B.5.6E-mailtom.beckers@kuleuven.be
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Propranolol EG (Eurogenerics NV) - 40 mg
    D.2.1.1.2Name of the Marketing Authorisation holderEurogenerics NV - Brussel
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePropranolol
    D.3.2Product code C07AA05
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Experimental study with healthy participants recruited from the general population; no vulnerable individuals or clinical groups will be involved. Our objective is to test wether the internal drug state induced by a single dose of propranolol (40 mg) is salient/potent enough to make retrieval of a conditioned fear memory reactivated before drug administration state-dependent.
    E.1.1.1Medical condition in easily understood language
    Experimental study with healthy participants recruited from the general population; no vulnerable individuals or clinical groups will be involved.
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Psychological processes [F02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The effect of drug state on memory retrieval after induced experimental amnesia using Propranolol EG 40 mg. Our objective is to test wether the internal drug state induced by a single dose of propranolol (40 mg) is salient/potent enough to make retrieval of a conditioned fear memory reactivated before drug administration state-dependent.
    E.2.2Secondary objectives of the trial
    Replication of earlier demonstrations of experimental amnesia after administration of a single dose of propranolol during fear memory reconsolidation (Kindt et al., 2009).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age: In principle, there are not limitations with respect of age, but to prevent excessive heterogeneity we will recruit adult participants between 18 and 40 years of age.
    - Sex: We will include both men and women.

    Healthy participants (N = 60) ranging in the age of 18 to 40 will take part in the study.
    E.4Principal exclusion criteria
    Participation in this study is contingent on participants not meeting a number of exclusion criteria:
    Some of those exclusion criteria are tied to the nature of the behavioral tasks that will be used (i.e., fear-conditioning) and have been determined in agreement with the KU Leuven Social and Societal Ethics Committee (SMEC). As such, we exclude pregnant woman, people with cardiovascular conditions, lung problems, neurologic conditions (e.g., epilepsy, seizures, convulsions), serious psychiatric conditions (depression, mania, psychosis, anxiety disorder) in the past or the present, or other serious medical conditions, people with pace-makers or other electronic implants, people with (uncorrected) hearing impairments and people with pain, injury or other medical conditions at the hands or wrists. Similarly excludes are people who have been advised by their physician to keep away from stressful situations.
    Specific exclusion criteria also apply for the administration of propranolol. Those include a history of low blood pressure, dizziness, or fainting, inability to perform moderate exercise, cardiac problems in first-degree relative, a history of diabetes, liver or kidney problems, metabolic acidosis, excessive production of thyroid hormone, circulatory problems, current use of medication that acts on the cardiac system, antihypertensive drugs, migraine medication, blood sugar level depression medication, gastric acid blinding drugs, anti-inflammatory agents, antidepressants, antipsychotics, anxiolytics, asthma medication, drugs against dizziness, migraine, tuberculosis, or psoriasis, known allergy for propranolol, current systolic blood pressure below 90 or diastolic blood pressure below 60, current heart rate at rest below 60 or heart rate immediately after two-step exercise test equal to or below heart rate at rest. We also exclude all participants with a score on the Anxiety Sensitivity Index above 25.
    E.5 End points
    E.5.1Primary end point(s)
    Our primary endpoint is to test whether the adminstration of propranolol on both day 2 (directly after reactivation of a fear memory) and day 3 (prior to extinction testing and reinstatement; i.e., the Propranolol-Propranolol group) recovers the conditioned fear responses (in fear potentiated startle) on day 3 relative to a group that receives propranolol on day 2 after reactivation of the CS+ but placebo on day 3 (Propranolol-Placebo group). For the latter group, we expect similar findings as Kindt and colleagues (2009), namely an absence of CS+/CS-/NA differentiation at the beginning of day 3 testing in fear-potentiated startle responses. A third (control) group that receives placebo on days 2 and 3 is included (Placebo-Placebo group) to ascertain that the lack of differential startle responding on day 3 in the Propranolol-Placebo is drug-specific. If the assumption is true that propranolol-induced amnesia is due to propranolol inducing an internal drug state which gets integrated within the initial memory trace, we should not see significant differences between the Placebo-Placebo group and the Propropranolol-Propranolol group in startle responding on day 3.
    We do not expect any differences between the conditions in US-expectancy ratings (in line with Kindt et al., 2009).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Three day protocol with a final evaluation test on day 3. Placebo/propranolol is administered on day 2 and day 3.
    E.5.2Secondary end point(s)
    Our second aim is to replicate the original study of Kindt et al. (2009), who showed that fear responses can be permanently weakened by administration of propranolol upon memory reactivation, preventing later return of fear. We will therefore include a fourth condition with no fear reminder trial on day 2 before the administration of propranolol. This group will receive placebo on day 3. We expect that this group will not show an attenuation of the differential startle response on day 3, since previous research with propranolol has indicated that reactivation of the fear memory is crucial to induce experimental amnesia (i.e., attenuation of the fear-potentiated startle response on a delayed retrieval test).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 3 or final test day.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial 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
    This study involves a three-day protocol, on three consecutive days. Participants will receive two single doses of propranolol and/or placebo, one on day 2 and one on day 3. We will exclude participants who respond to one or more of the exclusion criteria or participants who do not show proper acquisition. Withdrawn and/or excluded participants will be replaced until we have 15 participants per condition for further analysis.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    We provide all participants with contact details of several support services (including a therapist and clinical psychologist, a medical doctor, and the student counselor of our university) in case they need further assistance after the experiment or have the urge to talk to somebody (other than the researchers) about it. These people will be prepared to talk to the participant immediately or get back to them (e.g., contact by e-mail).
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-01-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-06-23
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