Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
68
Countries
1
Sites
12
Attention deficit hyperactivity disorder
Key facts
- Sponsor
- Boehringer Ingelheim International GmbH
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- 5 Aug 2025 → ongoing
- Decision date (initial)
- 2025-03-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514296-17-00
- WHO UTN
- U1111-1309-3549
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Attention deficit hyperactivity disorder
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Boehringer Ingelheim International GmbH
- Sponsor organisation
- Boehringer Ingelheim International GmbH
- Address
- Binger Strasse 173
- City
- Ingelheim Am Rhein
- Postcode
- 55216
- Country
- Germany
Scientific contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Public contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Locations
1 EU/EEA country · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 68 | 12 |
| Rest of world | — | 0 | — |
Investigational sites
Rheinhessen-Fachklinik Mainz
Abteilung für Kinder- und Jugendpsychiatrie, Hartmühlenweg 2-4, 55122, Mainz
Martin-Luther-Universitaet Halle-Wittenberg
Psychotherapie und Psychosomatik, Julius-Kuehn-Strasse 7, Am Wasserturm, Halle (Saale)
Universitaetsklinikum Bonn AöR
Klinik und Poliklinik für Psychiatrie und Psychotherapie, Venusberg-Campus 1, Venusberg, Bonn
Universitaetsklinikum Tuebingen AöR
Klinik für Psychiatrie und Psychotherapie, Calwerstrasse 14, Innenstadt, Tuebingen
Charite Research Organisation GmbH
Charité - Universitätsmedizin Berlin, Chariteplatz 1, Mitte, Berlin
Zentralinstitut Fuer Seelische Gesundheit
Klinik für Psychosomatik, Luisenring J 5, 68159, Mannheim
Goethe University Frankfurt
Klinik für Psychiatrie, Psychosomatik und Psychotherapie, Heinrich-Hoffmann-Strasse 10, Niederrad, Frankfurt Am Main
University Medical Center Hamburg-Eppendorf
Klinik und Poliklinik für Psychiatrie und Psychotherapie, Martinistrasse 52, Eppendorf, Hamburg
Medizinische Hochschule Hannover
Fraunhofer-Institut für Toxikologie und Experimentelle Medizin, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Universitaet Leipzig
Klinik und Poliklinik für Psychiatrie und Psychotherapie, Semmelweisstrasse 10, Zentrum-Suedost, Leipzig
Zentrum Fuer Integrative Psychiatrie ZIP gGmbH Praevention-Therapie-Rehabilitation
Praevention-Therapie-Rehabilitation, Niemannsweg 147, Duesternbrook, Kiel
Technische Universitaet Dresden
Klinik und Poliklinik für Psychiatrie und Psychotherapie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2025-08-05 | 2025-08-12 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-20 | Germany | Acceptable 2025-03-11
|
2025-03-13 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-04-09 | Germany | Acceptable 2025-03-11
|
2025-04-09 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-28 | Germany | Acceptable | 2025-06-20 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-04-24 | Germany | Acceptable 2026-05-13
|
2026-05-15 |