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Clinical trials for Drug Use Disorders During Pregnancy

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44393   clinical trials with a EudraCT protocol, of which   7405   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    1,025 result(s) found for: Drug Use Disorders During Pregnancy. Displaying page 22 of 52.
    EudraCT Number: 2019-000307-32 Sponsor Protocol Number: Repha_1439 Start Date*: 2020-05-12
    Sponsor Name:Repha GmbH
    Full Title: Clinical trial for examination of efficacy and safety of MYRRHINIL-INTEST® versus placebo in patients with diarrhea-dominant irritable bowel syndrom (IBS-D)
    Medical condition: Confirmed diagnosis of diarrhea-dominant irritable bowel syndrome (IBS-D) by a specialist physician and/or internal medicine and/or general medicine
    Disease: Version SOC Term Classification Code Term Level
    26.0 10017947 - Gastrointestinal disorders 10060845 Diarrhea predominant irritable bowel syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-001808-11 Sponsor Protocol Number: ID-064A202 Start Date*: 2019-01-14
    Sponsor Name:Idorsia Pharmaceuticals Ltd
    Full Title: A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe syste...
    Medical condition: Moderate to severe systemic lupus erythematosus
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10042945 Systemic lupus erythematosus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) GB (GB - no longer in EU/EEA) DE (Completed) ES (Ongoing) HU (Completed) BG (Completed) PL (Completed) GR (Completed) IT (Completed) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2011-004208-39 Sponsor Protocol Number: BAYq3939/15625 Start Date*: 2013-01-21
    Sponsor Name:Bayer HealthCare AG
    Full Title: Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus p...
    Medical condition: bronchiectasis
    Disease: Version SOC Term Classification Code Term Level
    18.1 10038738 - Respiratory, thoracic and mediastinal disorders 10006445 Bronchiectasis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) GB (Completed) IT (Completed) DK (Completed) FR (Completed) LV (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2020-001247-12 Sponsor Protocol Number: 20-001 Start Date*: 2021-03-30
    Sponsor Name:University Medical Center Groningen
    Full Title: An Open Label, Phase IV, Mechanistic, Study to Evaluate the Natriuretic Effect of 2-Week Dapagliflozin treatment in Type 2 Diabetes Mellitus Patients with Impaired Renal Function
    Medical condition: Type 2 diabetes mellitus (T2DM) with impaired renal function
    Disease: Version SOC Term Classification Code Term Level
    23.0 10027433 - Metabolism and nutrition disorders 10012607 Diabetes mellitus inadequate control PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-003770-14 Sponsor Protocol Number: 3030-202-002 Start Date*: 2018-10-11
    Sponsor Name:Allergan LTD
    Full Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Safety and Efficacy of Eluxadoline in Pediatric Patients (Age 12 to 17 Years) with Irrit...
    Medical condition: Irritable Bowel Syndrome with Diarrhea (IBS-D)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10017947 - Gastrointestinal disorders 10023003 Irritable bowel syndrome PT
    20.1 10017947 - Gastrointestinal disorders 10060845 Diarrhea predominant irritable bowel syndrome LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Prematurely Ended) HU (Completed) NL (Completed) DE (Prematurely Ended) PL (Completed) BG (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-003076-39 Sponsor Protocol Number: P11-05 Start Date*: 2012-10-10
    Sponsor Name:Bioprojet
    Full Title: A randomized, double blind study comparing BF2.649 (Pitolisant) to placebo in two parallel groups on the weekly frequency of cataplexy attacks and Excessive Daytime Sleepiness in narcoleptic patien...
    Medical condition: Narcolepsy with Cataplexy
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10028715 Narcolepsy with cataplexy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) BG (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2018-004655-20 Sponsor Protocol Number: LIGHT Start Date*: 2019-05-30
    Sponsor Name:HELLENIC INSTITUTE FOR THE STUDY OF SEPSIS
    Full Title: CLINICAL EFFICACY OF INHIBITION OF ORGAN DYSFUNCTION THROUGH BERMEKIMAB IN SYSTEMIC SCLEROSIS: A PROOF-OF-CONCEPT DOUBLE-BLIND RANDOMIZED CLINICAL TRIAL (THE LIGHT TRIAL)
    Medical condition: CLINICAL EFFICACY OF INHIBITION OF ORGAN DYSFUNCTION THROUGH BERMEKIMAB IN SYSTEMIC SCLEROSIS: A PROOF-OF-CONCEPT DOUBLE-BLIND RANDOMIZED CLINICAL TRIAL (THE LIGHT TRIAL)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10078638 Systemic scleroderma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-005035-41 Sponsor Protocol Number: THN102-201 Start Date*: 2018-05-29
    Sponsor Name:Theranexus SA
    Full Title: SAFETY AND EFFICACY OF THN102 ON SLEEPINESS IN NARCOLEPTIC PATIENTS
    Medical condition: This Proof-of-Concept, Phase IIa trial with THN102 should collect a sufficient body of information to assess efficacy and safety profile of THN102 versus modafinil alone in patient with a diagnosis...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10028713 Narcolepsy PT
    20.0 10029205 - Nervous system disorders 10028715 Narcolepsy with cataplexy LLT
    20.0 10029205 - Nervous system disorders 10007738 Cataplexy and narcolepsy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2015-000398-11 Sponsor Protocol Number: GS-US-205-0170 Start Date*: 2015-02-03
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy (CAT) Regimen of Inhaled Antibiotics for t...
    Medical condition: Cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa
    Disease: Version SOC Term Classification Code Term Level
    17.1 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2020-003469-20 Sponsor Protocol Number: CL07-ORY-2001 Start Date*: 2020-11-06
    Sponsor Name:Oryzon Genomics S.A.
    Full Title: A double blind, randomized, placebo-controlled, adaptive 14-week Phase IIb trial to evaluate the efficacy and safety of vafidemstat in an adult borderline personality disorder (BPD) population (POR...
    Medical condition: Borderline Personality Disorder (BPD)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10037175 - Psychiatric disorders 10006034 Borderline personality disorder PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2009-011200-39 Sponsor Protocol Number: PKI113009 Start Date*: 2010-01-22
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A six week randomized, double-blind, multi-center, placebocontrolled, exploratory, adaptive design study to explore the antidepressant properties of the p38 MAP kinase inhibitor GW856553 compared t...
    Medical condition: Major Depressive Disorder
    Disease: Version SOC Term Classification Code Term Level
    12.0 10025453 Major depressive disorder NOS LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) EE (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2021-006664-24 Sponsor Protocol Number: INVEX-CLIN-IIH-301 Start Date*: 2023-04-20
    Sponsor Name:Invex Therapeutics Ltd.
    Full Title: A Phase III randomised, placebo-controlled, double-blind, multi-centre, clinical trial to determine the efficacy and safety of Presendin in idiopathic intracranial hypertension
    Medical condition: Idiopathic intracranial hypertension
    Disease: Version SOC Term Classification Code Term Level
    23.1 10029205 - Nervous system disorders 10078904 Idiopathic intracranial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended) DE (Completed)
    Trial results: View results
    EudraCT Number: 2021-002482-17 Sponsor Protocol Number: TAK-935-3003 Start Date*: 2022-05-09
    Sponsor Name:Takeda Development Center Americas, Inc
    Full Title: A Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term Safety and Tolerability of Soticlestat as Adjunctive Therapy in Subjects With Dravet Syndrome or ...
    Medical condition: Dravet Syndrome (DS) Lennox-Gastaut Syndrome (LGS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10073682 Dravet syndrome LLT
    20.1 10029205 - Nervous system disorders 10048816 Lennox-Gastaut syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) ES (Trial now transitioned) NL (Trial now transitioned) HU (Trial now transitioned) FR (Trial now transitioned) GR (Trial now transitioned) IT (Trial now transitioned) LV (Trial now transitioned) PL (Trial now transitioned) Outside EU/EEA DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-003280-38 Sponsor Protocol Number: PSY-NIL-0006 Start Date*: 2016-05-04
    Sponsor Name:Medical University of Vienna
    Full Title: Positron Emission Tomography assessment of Ketamine Binding of the Serotonin Transporter and its Relevance for Rapid Antidepressant Response
    Medical condition: 20 patients with severe unipolar depression (structured clinical interview for DSM-IV and the 17-item Hamilton Depression Rating Scale), also 20 age and sex matched healthy controls. plus 12 HC f...
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004873 10045543 Unipolar depression LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2008-001429-32 Sponsor Protocol Number: CACZ885D2201 Start Date*: 2012-03-09
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multi-center, open label, 24-month treatment study to establish the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of canakinumab (anti-IL-1 beta antibody) in patients with...
    Medical condition: Neonatal onset multisystem inflammatory disease (abbreviated NOMID, also known as chronic infantile neurologic cutaneous and articular syndrome or CINCA)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10068850 Cryopyrin associated periodic syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2020-003119-88 Sponsor Protocol Number: SECURA Start Date*: 2021-02-09
    Sponsor Name:IRCCS ISTITUTO CLINICO HUMANITAS
    Full Title: EVALUATION OF AUTOIMMUNITY IN PSORIASIS FOLLOWING IL-17A NEUTRALIZATION: A BASE TO OPTIMISE USE OF BIOLOGICS IN PSORIASIS
    Medical condition: moderate to severe plaque psoriasis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10037153 Psoriasis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2021-003338-35 Sponsor Protocol Number: D7552C00001 Start Date*: 2022-06-06
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase 2, Randomised, Double-Blind, Placebo-Controlled Study to Assess Efficacy and Safety of Multiple Dose Levels of Atuliflapon Given Orally Once Daily for Twelve Weeks in Adults with Moderate-t...
    Medical condition: Moderate-to-Severe Uncontrolled Asthma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) PL (Trial now transitioned) HU (Trial now transitioned) BG (Trial now transitioned) SI (Trial now transitioned) SK (Trial now transitioned) NL (Trial now transitioned) IT (Prematurely Ended) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-004664-18 Sponsor Protocol Number: NEOD001-OLE251 Start Date*: 2017-08-08
    Sponsor Name:Prothena Therapeutics Limited
    Full Title: A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001-201 (PRONTO)
    Medical condition: The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021428 - Immune system disorders 10036673 Primary amyloidosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DE (Prematurely Ended) ES (Prematurely Ended) GR (Completed) AT (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-010110-30 Sponsor Protocol Number: MK-0887A-087 Start Date*: 2016-03-15
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A phase III, randomized, active-controlled, parallel-group clinical trial to study the efficacy and long-term safety of mometasone furoate / formoterol fumarate (MF/F, MK-0887A [SCH418131]), compar...
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    18.1 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: LV (Completed) HU (Completed) DK (Prematurely Ended) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-004917-26 Sponsor Protocol Number: PS-G202 Start Date*: 2016-11-08
    Sponsor Name:Parion Sciences, Incorporated
    Full Title: A Phase 2a, Two-part, Randomized, Double-blind, Placebo-controlled, Incomplete Block Crossover Study to Evaluate the Safety and Efficacy of VX-371 Solution for Inhalation With and Without Oral Ivac...
    Medical condition: Primary Ciliary Dyskinesia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10069713 Primary ciliary dyskinesia PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) DK (Completed) NL (Completed) PL (Completed) GB (Completed) IT (Completed)
    Trial results: View results
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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