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Clinical trials for Tolperisone

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   44336   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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    8 result(s) found for: Tolperisone. Displaying page 1 of 1.
    EudraCT Number: 2021-006042-13 Sponsor Protocol Number: MEDI-TOLP-01 Start Date*: 2022-03-28
    Sponsor Name:MEDITOP Gyógyszeripari Kft.
    Full Title: A randomized double blind placebo controlled multicenter study to assess the efficacy and tolerability of tolperisone as add on treatment with standardized NSAID of acute non specific low back pain.
    Medical condition: Acute, non-specific low back pain
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004859 10024891 Low back pain LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: View results
    EudraCT Number: 2009-013864-37 Sponsor Protocol Number: 71231 Start Date*: 2010-02-05
    Sponsor Name:Gedeon Richter Plc.
    Full Title: A randomized, multicenter, double-blind, parallel study to compare the efficacy and safety profile of RGH-507 (tolperisone-containing) gel versus a ketoprofen-containing gel in the treatment of pat...
    Medical condition: acute soft tissue injury minor traumatism (such as: sprain, strain, dislocation,...etc.) or contusion
    Disease: Version SOC Term Classification Code Term Level
    12.0 10041291 Soft tissue injury PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: View results
    EudraCT Number: 2019-001885-14 Sponsor Protocol Number: LOWBACK-SE Start Date*: 2019-08-06
    Sponsor Name:National Research, Development and Innovation Office
    Full Title: The prognostic value of Biomarkers and the Effect of Tolperisone in Acute low back pain and sciatic pain – BETA A Phase 3 investigator initiated study
    Medical condition: Acute low back pain with or withour radicular signs
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-001031-63 Sponsor Protocol Number: AV650-018 Start Date*: 2007-09-20
    Sponsor Name:Avigen Inc
    Full Title: AV650-018: A two-part (double-blind followed by open-label), placebo-controlled, randomized trial to assess the safety, tolerability, and preliminary efficacy of AV650 (tolperisone HCl) in subjects...
    Medical condition: Spasticity associated with multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10028335 Muscle spasticity LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended) DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2004-003735-31 Sponsor Protocol Number: 62179 Start Date*: 2005-05-20
    Sponsor Name:Gedeon Richter LTD
    Full Title: Randomizált, kettős vak, multicentrikus vizsgálat disztális, szenzomotoros típusú diabéteszes neuropátiás fájdalomban az együttesen adott emelkedő dózisú 150 mg-os tolperisone filmtabletta és 30 mg...
    Medical condition: Disztális-szenzomotoros típusú diabéteszes neuropátiás fájdalom
    Disease: Version SOC Term Classification Code Term Level
    7.1 10012680 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-004100-22 Sponsor Protocol Number: OS440-3004 Start Date*: 2018-03-16
    Sponsor Name:Osmotica Pharmaceutical US LLC
    Full Title: A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Arbaclofen Extended-Release Tablets for the Treatment of Spasticity in Patients with Mu...
    Medical condition: Spasticity in patients with multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10041416 Spasticity LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed) PL (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2017-004101-40 Sponsor Protocol Number: OS440-3005 Start Date*: 2018-03-23
    Sponsor Name:Osmotica Pharmaceutical US LLC
    Full Title: An Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity (Study OS440-3005).
    Medical condition: Spasticity in patients with multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10041416 Spasticity LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed) PL (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2007-000236-16 Sponsor Protocol Number: IPX056-B06-03 Start Date*: 2007-05-28
    Sponsor Name:IMPAX Laboratories, Inc.
    Full Title: A Double-Blind, Randomized, Placebo- and Active Comparator- Controlled, Parallel Group, Multinational Study to Evaluate the Pharmacokinetics and Pharmacodynamics of IPX056 in Subjects with Establis...
    Medical condition: Established Spasticity Resulting from Multiple Sclerosis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10041416 Spasticity LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: EE (Completed) LV (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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