Clinical Trial Page
| Summary | |
|---|---|
| EudraCT Number: | 2020-000160-28 |
| Sponsor's Protocol Code Number: | MusicPlasticity |
| National Competent Authority: | Austria - BASG |
| Clinical Trial Type: | EEA CTA |
| Trial Status: | Ongoing |
| Date on which this record was first entered in the EudraCT database: | 2020-07-14 |
| Trial results | |
| A. Protocol Information | ||||
|---|---|---|---|---|
| A.1 | Member State Concerned | Austria - BASG | ||
| A.2 | EudraCT number | 2020-000160-28 | ||
| A.3 | Full title of the trial |
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| A.3.1 | Title of the trial for lay people, in easily understood, i.e. non-technical, language |
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| A.4.1 | Sponsor's protocol code number | MusicPlasticity | ||
| A.7 | Trial is part of a Paediatric Investigation Plan | No | ||
| A.8 | EMA Decision number of Paediatric Investigation Plan | |||
| B. Sponsor Information | ||
|---|---|---|
| B.Sponsor: 1 | ||
| B.1.1 | Name of Sponsor | Medical University of Vienna |
| B.1.3.4 | Country | Austria |
| B.3.1 and B.3.2 | Status of the sponsor | Non-Commercial |
| B.4 Source(s) of Monetary or Material Support for the clinical trial: | ||
| B.4.1 | Name of organisation providing support | Medical University of Vienna |
| B.4.2 | Country | Austria |
| B.5 Contact point designated by the sponsor for further information on the trial | ||
| B.5.1 | Name of organisation | Medical University of Vienna |
| B.5.2 | Functional name of contact point | Neuroimaging Labs |
| B.5.3 | Address: | |
| B.5.3.1 | Street Address | Währingergürtel 18-20 |
| B.5.3.2 | Town/ city | Vienna |
| B.5.3.3 | Post code | 1090 |
| B.5.3.4 | Country | Austria |
| B.5.4 | Telephone number | 00431404003574 |
| D. IMP Identification | ||
|---|---|---|
| D.IMP: 1 | ||
| D.1.2 and D.1.3 | IMP Role | Test |
| D.2 | Status of the IMP to be used in the clinical trial | |
| D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
| D.2.1.1.1 | Trade name | Cipralex |
| D.2.1.1.2 | Name of the Marketing Authorisation holder | Lundbeck |
| D.2.1.2 | Country which granted the Marketing Authorisation | Austria |
| D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
| D.2.5.1 | Orphan drug designation number | |
| D.3 Description of the IMP | ||
| D.3.4 | Pharmaceutical form | Tablet |
| D.3.4.1 | Specific paediatric formulation | No |
| D.3.7 | Routes of administration for this IMP | Oral use |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | escitalopram |
| D.3.9.3 | Other descriptive name | ESCITALOPRAM OXALATE |
| D.3.9.4 | EV Substance Code | SUB16426MIG |
| D.3.10 | Strength | |
| D.3.10.1 | Concentration unit | mg milligram(s) |
| D.3.10.2 | Concentration type | equal |
| D.3.10.3 | Concentration number | 10 |
| D.3.11 The IMP contains an: | ||
| D.3.11.1 | Active substance of chemical origin | Yes |
| D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
| The IMP is a: | ||
| D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
| D.3.11.3.1 | Somatic cell therapy medicinal product | No |
| D.3.11.3.2 | Gene therapy medical product | No |
| D.3.11.3.3 | Tissue Engineered Product | No |
| D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
| D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
| D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
| D.3.11.5 | Radiopharmaceutical medicinal product | No |
| D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
| D.3.11.7 | Plasma derived medicinal product | No |
| D.3.11.8 | Extractive medicinal product | No |
| D.3.11.9 | Recombinant medicinal product | No |
| D.3.11.10 | Medicinal product containing genetically modified organisms | No |
| D.3.11.11 | Herbal medicinal product | No |
| D.3.11.12 | Homeopathic medicinal product | No |
| D.3.11.13 | Another type of medicinal product | No |
| D.8 Information on Placebo | ||
|---|---|---|
| D.8 Placebo: 1 | ||
| D.8.1 | Is a Placebo used in this Trial? | Yes |
| D.8.3 | Pharmaceutical form of the placebo | Tablet |
| D.8.4 | Route of administration of the placebo | Oral use |
| E. General Information on the Trial | ||||
|---|---|---|---|---|
| E.1 Medical condition or disease under investigation | ||||
| E.1.1 | Medical condition(s) being investigated |
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| E.1.1.1 | Medical condition in easily understood language |
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| E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Behaviours [F01] | ||
| MedDRA Classification | ||||
| 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 |
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| E.2.2 | Secondary objectives of the trial |
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| E.2.3 | Trial contains a sub-study | No | ||
| E.3 | Principal inclusion criteria |
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| E.4 | Principal exclusion criteria |
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| E.5 End points | ||||
| E.5.1 | Primary end point(s) |
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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 | No | ||
| E.6.5 | Efficacy | No | ||
| E.6.6 | Pharmacokinetic | No | ||
| E.6.7 | Pharmacodynamic | Yes | ||
| 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) | No | ||
| E.7.4 | Therapeutic use (Phase IV) | Yes | ||
| 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) | No | ||
| E.8.2.2 | Placebo | Yes | ||
| E.8.2.3 | Other | No | ||
| E.8.2.4 | Number of treatment arms in the trial | 2 | ||
| 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 | No | ||
| E.8.6 Trial involving sites outside the EEA | ||||
| E.8.6.1 | Trial being conducted both within and outside the EEA | No | ||
| E.8.6.2 | Trial being conducted completely outside of the EEA | No | ||
| 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 |
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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 | 3 | ||
| E.8.9.1 | In the Member State concerned months | |||
| E.8.9.1 | In the Member State concerned days | |||
| F. Population of Trial Subjects | |||
|---|---|---|---|
| F.1 Age Range | |||
| F.1.1 | Trial has subjects under 18 | No | |
| F.1.1.1 | In Utero | No | |
| F.1.1.2 | Preterm newborn infants (up to gestational age < 37 weeks) | No | |
| F.1.1.3 | Newborns (0-27 days) | No | |
| F.1.1.4 | Infants and toddlers (28 days-23 months) | No | |
| F.1.1.5 | Children (2-11years) | No | |
| F.1.1.6 | Adolescents (12-17 years) | No | |
| F.1.2 | Adults (18-64 years) | Yes | |
| F.1.2.1 | Number of subjects for this age range: | 80 | |
| F.1.3 | Elderly (>=65 years) | No | |
| F.2 Gender | |||
| F.2.1 | Female | Yes | |
| F.2.2 | Male | Yes | |
| F.3 Group of trial subjects | |||
| F.3.1 | Healthy volunteers | Yes | |
| F.3.2 | Patients | Yes | |
| F.3.3 | Specific vulnerable populations | Yes | |
| F.3.3.1 | Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-07-14. | Yes | |
| F.3.3.2 | Women of child-bearing potential using contraception | Yes | |
| F.3.3.3 | Pregnant women | No | |
| F.3.3.4 | Nursing women | No | |
| F.3.3.5 | Emergency situation | No | |
| F.3.3.6 | Subjects incapable of giving consent personally | No | |
| F.3.3.7 | Others | No | |
| F.4 Planned number of subjects to be included | |||
| F.4.1 | In the member state | 80 | |
| 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) |
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| G. Investigator Networks to be involved in the Trial |
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| N. Review by the Competent Authority or Ethics Committee in the country concerned | ||
|---|---|---|
| N. | Competent Authority Decision | Authorised |
| N. | Date of Competent Authority Decision | 2020-08-28 |
| N. | Ethics Committee Opinion of the trial application | Favourable |
| N. | Ethics Committee Opinion: Reason(s) for unfavourable opinion | |
| N. | Date of Ethics Committee Opinion | 2020-06-03 |
| P. End of Trial | ||
|---|---|---|
| P. | End of Trial Status | Ongoing |