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Clinical trials for Dantrolene

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   44335   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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    17 result(s) found for: Dantrolene. Displaying page 1 of 1.
    EudraCT Number: 2020-004281-19 Sponsor Protocol Number: 1.5 Start Date*: 2022-06-08
    Sponsor Name:Region Stockholm Karolinska University Hospital (Dep. of Dermatology)
    Full Title: Investigator initiated clinical trial of dantrolene as a treatment for Darier disease
    Medical condition: Darier disease is a rare and severe autosomal dominant skin disorder.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-005292-14 Sponsor Protocol Number: not_applicable Start Date*: 2013-01-09
    Sponsor Name:Heikki Swan
    Full Title: Dantrolene in catecholaminiergic polymorphic ventricular tachycardia
    Medical condition: Catecholaminergic polymorphic ventricular tachycardia
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004849 10036095 Polymorphic ventricular tachycardia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-003232-35 Sponsor Protocol Number: 197-2004 Start Date*: 2007-08-17
    Sponsor Name:Medizin Universität Wien
    Full Title: Dantrolen as treatment for hyperthermia in patients with subarachnoidal hemorrhage
    Medical condition: Fever episodes occur in more than 50%of patients with subarachnoidal hemorrhage despite antibiotic and antipyretic therapy.The exact mechanism of hyperthermia-induced brain injury is not known. Hyp...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020846 Hyperthermia therapy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-004451-40 Sponsor Protocol Number: H15/02 Start Date*: 2016-02-17
    Sponsor Name:Almirall Hermal GmbH
    Full Title: SATIVEX® AS ADD-ON THERAPY VS. FURTHER OPTIMIZED FIRST-LINE ANTISPASTICS THE S A V A N T TRIAL
    Medical condition: Moderate to severe spasticity due to MS (multiple sclerosis).
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004852 10052785 Multiple sclerosis acute and progressive HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2020-004306-58 Sponsor Protocol Number: GWSP20104 Start Date*: 2022-01-28
    Sponsor Name:GW Pharma Limited
    Full Title: A randomized double-blind placebo-controlled study of nabiximols in patients with spasticity in multiple sclerosis
    Medical condition: Symptomatic treatment of spasticity in patients with MS
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029205 - Nervous system disorders 10028245 Multiple sclerosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (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: 2012-003771-18 Sponsor Protocol Number: GWSP08258 Start Date*: 2013-08-06
    Sponsor Name:GW Pharma Ltd.
    Full Title: The efficacy, safety and tolerability of Sativex as an adjunctive treatment to existing anti-spasticity medications in children aged 8 to 18 years with spasticity due to cerebral palsy or traumatic...
    Medical condition: Spasticity due to cerebral palsy (CP) or traumatic central nervous system injury.
    Disease: Version SOC Term Classification Code Term Level
    18.1 10029205 - Nervous system disorders 10028335 Muscle spasticity PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2012-000062-38 Sponsor Protocol Number: 191622-101 Start Date*: 2013-07-08
    Sponsor Name:Allergan Limited
    Full Title: BOTOX® Treatment in Pediatric Upper Limb Spasticity: Double-blind Study
    Medical condition: Upper Limb Spasticity.
    Disease: Version SOC Term Classification Code Term Level
    15.1 10029205 - Nervous system disorders 10028335 Muscle spasticity PT
    15.1 10029205 - Nervous system disorders 10048970 Arm spasticity LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed) HU (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-000042-35 Sponsor Protocol Number: 191622-111 Start Date*: 2013-07-08
    Sponsor Name:Allergan Limited
    Full Title: BOTOX® Treatment in Pediatric Lower Limb Spasticity: Double-blind Study
    Medical condition: Lower Limb Spasticity
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10028335 Muscle spasticity PT
    14.1 10029205 - Nervous system disorders 10024132 Leg spasticity LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed) HU (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-000043-27 Sponsor Protocol Number: 191622-105 Start Date*: Information not available in EudraCT
    Sponsor Name:Allergan Limited
    Full Title: BOTOX® Treatment in Pediatric Upper Limb Spasticity: Open-label Study
    Medical condition: Upper limb spasticity
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10028335 Muscle spasticity PT
    14.1 10029205 - Nervous system disorders 10048970 Arm spasticity LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed) HU (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-000084-24 Sponsor Protocol Number: 191622-112 Start Date*: 2013-07-08
    Sponsor Name:Allergan Limited
    Full Title: BOTOX® Treatment of Pediatric Lower Limb Spasticity: Open-label Study
    Medical condition: Lower Limb Spasticity
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10028335 Muscle spasticity PT
    14.1 10029205 - Nervous system disorders 10024132 Leg spasticity LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed) HU (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-004980-63 Sponsor Protocol Number: 191622-116 Start Date*: 2012-02-08
    Sponsor Name:Allergan Ltd.
    Full Title: BOTOX® Treatment in Adult Patients with Post-Stroke Lower Limb Spasticity
    Medical condition: Post-Stroke Lower Limb Spasticity
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004852 10042244 Stroke LLT
    16.1 100000004852 10024132 Leg spasticity LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) DE (Completed) GB (Completed) CZ (Completed) PL (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
    EudraCT Number: 2019-002625-29 Sponsor Protocol Number: GWSP19066 Start Date*: 2020-01-14
    Sponsor Name:GW Pharma Limited
    Full Title: A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients with Multiple Sclerosis
    Medical condition: Symptomatic treatment of spasticity in patients with multiple sclerosis (MS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10028335 Muscle spasticity PT
    20.1 10029205 - Nervous system disorders 10028245 Multiple sclerosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed) GB (GB - no longer in EU/EEA) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2019-002623-14 Sponsor Protocol Number: GWSP18023 Start Date*: 2020-03-17
    Sponsor Name:GW Pharma Ltd
    Full Title: A Double-blind, Randomized, Placebo-controlled, Parallel-group Trial of the Efficacy and Safety of Nabiximols Oromucosal Spray as Add-on Therapy in Patients with Spasticity Due to Multiple Sclerosis
    Medical condition: Symptomatic relief of spasticity in Multiple Sclerosis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029205 - Nervous system disorders 10028245 Multiple sclerosis PT
    20.0 10029205 - Nervous system disorders 10028335 Muscle spasticity PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: CZ (Completed) PL (Completed) GB (GB - no longer in EU/EEA) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2009-011216-38 Sponsor Protocol Number: 1.02.7001 Start Date*: 2009-09-01
    Sponsor Name:Medtronic International Trading Sarl
    Full Title: A randomized, controlled, open-label, parallel-group, multicenter study to compare the effect of Intrathecal Baclofen Therapy (ITB Therapy) versus Best Medical Treatment (BMT) on severe spasticity ...
    Medical condition: Severe spasticity in post-stroke patients
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004852 10041416 Spasticity LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) ES (Completed) BE (Completed) DE (Completed) IT (Completed) NL (Completed) GB (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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