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Clinical trials for low dose naltrexone

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   44334   clinical trials with a EudraCT protocol, of which   7366   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 ).  
     
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    11 result(s) found for: low dose naltrexone. Displaying page 1 of 1.
    EudraCT Number: 2015-002972-26 Sponsor Protocol Number: LDN_7323 Start Date*: 2015-12-14
    Sponsor Name:Smerteklinikken
    Full Title: Low dose naltrexone for treatment of pain in patients with fibromyalgia - effect via central mechanism? A randomized, double-blinded, placebo-controlled, cross-over study
    Medical condition: Pain in patients with fibromylagia
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004867 10049475 Chronic pain LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2005-005679-13 Sponsor Protocol Number: NALTREX005 Start Date*: 2006-06-28
    Sponsor Name:OSPEDALE S. RAFFAELE
    Full Title: An open-label, prospective, multicentric pilot study evaluating safety and symptomatics effects of low dose Naltrexone in patients with primary progressive multiple sclerosis.
    Medical condition: multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    6.1 10053395 PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-002081-31 Sponsor Protocol Number: 16008 Start Date*: 2016-11-17
    Sponsor Name:Anæstesiologisk-intensiv afd V, Odense Universitets Hospital
    Full Title: Investigation of dose response relationships when using low dose naltrexone (LDN) for the treatment of fibromyalgia
    Medical condition: Fibromyalgia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004859 10016631 Fibromyalgia syndrome LLT
    Population Age: Adults Gender: Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2019-000702-30 Sponsor Protocol Number: 18.021 Start Date*: 2019-10-30
    Sponsor Name:Odense University Hospital
    Full Title: Fibromyalgia and Naltrexone: The FINAL study
    Medical condition: Fibromyalgia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10048439 Fibromyalgia PT
    Population Age: Adults Gender: Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2019-000852-32 Sponsor Protocol Number: 80-84800-98-82002 Start Date*: 2020-01-30
    Sponsor Name:ErasmusMC
    Full Title: A preliminary study of Low Dose Naltrexone for the induction of remission in patients with mild to moderate Crohn’s Disease that failed conventional treatment: The LDN Crohn study.
    Medical condition: Inflammatory Bowel Disease, Crohn's disease
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2022-000245-33 Sponsor Protocol Number: VN21 Start Date*: 2022-05-31
    Sponsor Name:Medical University of Lublin
    Full Title: To evaluate the effect of low-dose naltrexone (LDN) on pain perception and quality of life in women
    Medical condition: Vulvodynia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004872 10047781 Vulvodynia LLT
    Population Age: Adults Gender: Female
    Trial protocol: PL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2021-002534-16 Sponsor Protocol Number: FSJD-INNOVA-2020 Start Date*: 2021-10-15
    Sponsor Name:Fundació Sant Joan de Déu
    Full Title: 12-month randomized, double-blind, placebo-controlled, pharmacological clinical trial to evaluate the effectiveness, cost-utility and neurobiological effects of low-dose Naltrexone in patients with...
    Medical condition: Fibromyalgia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10048439 Fibromyalgia PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-004273-10 Sponsor Protocol Number: 3200L2-300-WW Start Date*: 2007-01-08
    Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals Inc.
    Full Title: A multicenter, randomized, double-blind, placebo-controlled, parallel-group study of intravenous Methylnaltrexone (MOA-728) for the treatment of post operative ileus
    Medical condition: Post operative ileus (POI) in patients who have had a segmental colectomy via open laparotomy.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) IT (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2022-002695-37 Sponsor Protocol Number: CLIN-60190-453 Start Date*: 2023-04-27
    Sponsor Name:Ipsen Bioscience, Inc.
    Full Title: A Phase II, Multicenter, Double-Blind, Randomised, Placebo-Controlled Study and Open-Label Long Term Extension to Evaluate the Safety and Efficacy of Elafibranor in Adult Participants with Primary ...
    Medical condition: Adults patients with Primary Sclerosing Cholangitis (PSC)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10019805 - Hepatobiliary disorders 10036732 Primary sclerosing cholangitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) ES (Ongoing) PT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-004941-34 Sponsor Protocol Number: GFT505B-319-1 Start Date*: 2020-10-09
    Sponsor Name:IPSEN Pharma SAS
    Full Title: A Double-blind Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Ina...
    Medical condition: Primary Biliary Cholangitis
    Disease: Version SOC Term Classification Code Term Level
    21.0 10019805 - Hepatobiliary disorders 10034176 PBC LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) DE (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-004431-79 Sponsor Protocol Number: CC-90001-NASH-001 Start Date*: 2019-11-15
    Sponsor Name:Celgene Corporation
    Full Title: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, DOSEFINDING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-90001 IN SUBJECTS WITH NONALCOHOLIC STEATOHEPATITIS (NASH) AND LIVE...
    Medical condition: Confirmed diagnosis of NASH and Stage 3 or Stage 4 fibrosis based upon the NASH Clinical Research Network (CRN) Histologic Scoring System and a nonalcoholic fatty liver disease (NAFLD) Activity Sco...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Prematurely Ended) ES (Ongoing) PL (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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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