Mitoxantrone ( DrugBank: Mitoxantrone )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
13多発性硬化症/視神経脊髄炎17

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,342 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241
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PhaseCountries
1NCT01627938
(ClinicalTrials.gov)
April 201230/5/2012Study to Evaluate the Reduction of Cardiac Problems in Multiple Sclerosis Patients With Mitoxantrone and Dexrazoxane in CombinationA Phase II Proof of Concept Study Evaluating the Reduction of Mitoxantrone-induced Cardiotoxicity and Neurological Outcome in the Combined Use of Mitoxantrone and Dexrazoxane (Cardioxane®) in Multiple Sclerosis (MSCardioPro)Multiple SclerosisDrug: Dexrazoxane (DRZ) plus Mitoxantrone (MX);Drug: Placebo plus Mitoxantrone (MX)PD Dr. Andrew ChanNULLActive, not recruiting18 Years55 YearsBoth50Phase 2Germany
2NCT02937285
(ClinicalTrials.gov)
November 20109/9/2016National Multicenter, Controlled, Single-blind Study With Two Parallel Groups Evaluating the Safety and Efficacy of Sequential Treatment With Mitoxantrone and Interferon Versus Interferon Alone in Patients With Strong Risk of Progression in the Initial Phase of Multiple SclerosisNational Multicenter, Controlled, Single-blind Study With Two Parallel Groups Evaluating the Safety and Efficacy of Sequential Treatment With Mitoxantrone and Interferon Beta-1a (REBIF 44mg 3 Times / Week) Versus Interferon Alone in Patients With Strong Risk of Progression in the Initial Phase of Multiple SclerosisMultiple SclerosisDrug: Interferon beta 1a;Drug: MitoxantroneRennes University HospitalNULLActive, not recruiting18 Years50 YearsAll266Phase 3France
3NCT01065727
(ClinicalTrials.gov)
February 20108/2/2010Impact Study of 2 Therapeutic Strategy for Aggressive Remitting Multiple SclerosisStudy Impact, on Clinical Outcomes, Quality of Life and Costs of 2 Therapeutic Strategy (Monthly Natalizumab Versus Mitoxantrone Then Immunomodulator) at 3 Years of Follow-up for Aggressive Remitting Multiple SclerosisMultiple SclerosisOther: mitoxantrone - immunomodulator;Other: natalizumabRennes University HospitalNULLRecruiting18 YearsN/ABoth250N/AFrance
4EUCTR2009-010661-23-IT
(EUCTR)
30/07/200910/01/2011MITOXANTRONE/GLATIRAMER ACETATE COMBINED TREATMENT IN THE THERAPY OF SECONDARY-PROGRESSIVE MULTIPLE SCLEROSIS - aMICO STUDYMITOXANTRONE/GLATIRAMER ACETATE COMBINED TREATMENT IN THE THERAPY OF SECONDARY-PROGRESSIVE MULTIPLE SCLEROSIS - aMICO STUDY subjects affected by secondary-progressive Multiple Sclerosis
MedDRA version: 9.1;Level: SOC;Classification code 10029205
INN or Proposed INN: Mitoxantrone
INN or Proposed INN: Glatiramer acetate
AZIENDA OSPEDALIERA UNIVERSITARIA DELLA SECONDA UNIVERSITA` DEGLI STUDI DI NAPOLINULLNot RecruitingFemale: yes
Male: yes
Italy
5NCT02021825
(ClinicalTrials.gov)
March 20093/9/2013Efficacy and Safety of Mitoxantrone in Patients With Refractory Neuromyelitis Optica and Spectrum DisordersEfficacy and Safety of Mitoxantrone in Patients With Refractory Neuromyelitis Optica and Spectrum DisordersNeuromyelitis Optica;Neuromyelitis Optica Spectrum DisordersDrug: MitoxantroneXuanwu Hospital, BeijingNULLRecruiting18 Years55 YearsBoth50Phase 4China
6EUCTR2008-000256-26-GB
(EUCTR)
16/02/200908/12/2010An exploratory phase IIa study to evaluate the safety and immunological effects of intravenous interferonß-1a (IFNß-1a, Rebif®) therapy in the induction of tolerance to IFNß in MS patients with neutralising antibodies (NAbs) to subcutaneous IFNß-1a (Rebif® or Avonex®) - Tolerance induction with intravenous IFNß-1aAn exploratory phase IIa study to evaluate the safety and immunological effects of intravenous interferonß-1a (IFNß-1a, Rebif®) therapy in the induction of tolerance to IFNß in MS patients with neutralising antibodies (NAbs) to subcutaneous IFNß-1a (Rebif® or Avonex®) - Tolerance induction with intravenous IFNß-1a Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Trade Name: Mitoxantrone
Product Name: Mitoxantrone
Product Code: PL 04515/0127
Trade Name: Rebif®
INN or Proposed INN: Mitoxantrone
Queen Mary, University of LondonNULLNot RecruitingFemale: yes
Male: yes
15Phase 2United Kingdom
7EUCTR2007-001962-34-DE
(EUCTR)
12/12/200705/11/2007Klassische Konditionierung immunologischer Reaktionen bei Patienten mit Multipler Sklerose während Mitoxantrontherapie - MIMIKKlassische Konditionierung immunologischer Reaktionen bei Patienten mit Multipler Sklerose während Mitoxantrontherapie - MIMIK secondary progressive multiple sclerosisTrade Name: Ralenova
INN or Proposed INN: mitoxantrone
University Medical Center Hamburg EppendorfNULLNot RecruitingFemale: yes
Male: yes
5Germany
8EUCTR2004-001286-17-PT
(EUCTR)
08/09/200623/03/2006Exploratory trial to evaluate the risk-benefit ratio of the use of mitoxantrone in patients under treatment with high dose interferon-beta-1a for relapsing-remitting or relapsing secondary progresive multiple sclerosis with high activity. - Mitoxantrone in high activity multiple sclerosisExploratory trial to evaluate the risk-benefit ratio of the use of mitoxantrone in patients under treatment with high dose interferon-beta-1a for relapsing-remitting or relapsing secondary progresive multiple sclerosis with high activity. - Mitoxantrone in high activity multiple sclerosis Relapsing-remitting or relapsing secondary progressive multiple sclerosis with high activity
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Mitoxantrone
Product Code: N/A
Fundación Española de Esclerosis Múltiple (FEDEM)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Portugal
9NCT01142466
(ClinicalTrials.gov)
December 200510/6/2010A Phase IV Study of Rebif ® 44mcg Administered Three Times Per Week by Subcutaneous Injection Compared With no Treatment in the Therapy of Relapsing Multiple Sclerosis After MitoxantronePhase IV, Multicenter, Open Label, Randomized Study of Rebif® 44mcg Administered Three Times Per Week by Subcutaneous Injection Compared With no Treatment in the Therapy of Relapsing Multiple Sclerosis After MitoxantroneMultiple Sclerosis, Relapsing-RemittingDrug: Interferon beta-1a (Rebif)Merck KGaAGesellschaft für Therapieforschung mbHCompleted18 Years60 YearsAll30Phase 4NULL
10EUCTR2004-004903-39-GB
(EUCTR)
26/07/200514/06/2005A pilot multi-centre randomised controlled trial of sequential treatment with Mitoxantrone and Glatiramer Acetate vs. Interferon Beta-1a in early active relapsing remitting Multiple Sclerosis. - UNKEMPTA pilot multi-centre randomised controlled trial of sequential treatment with Mitoxantrone and Glatiramer Acetate vs. Interferon Beta-1a in early active relapsing remitting Multiple Sclerosis. - UNKEMPT Early, active relapsing remitting Multiple Sclerosis (RRMS)Trade Name: Mitoxantrone
Product Name: Mitoxantrone
Trade Name: Copaxone
Product Name: Glatiramer Acetate
Trade Name: Rebif 44
Product Name: Interferon Beta 1a
The Walton Centre for Neurology and NeurosurgeryNULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
11EUCTR2005-001026-89-DE
(EUCTR)
14/07/200513/05/2005Phase IV, multicenter, open label, randomized study of Rebif® 44 mcg administered three times per week by subcutaneous injection compared with no treatment in the therapy of relapsing multiple sclerosis after mitoxantrone - Deescalation to Rebif® after Mitoxantrone therapy (REMAIN study)Phase IV, multicenter, open label, randomized study of Rebif® 44 mcg administered three times per week by subcutaneous injection compared with no treatment in the therapy of relapsing multiple sclerosis after mitoxantrone - Deescalation to Rebif® after Mitoxantrone therapy (REMAIN study) Relapsing-remitting multiple sclerosis (RRMS) or secondary progressive multiple sclerosis (SPMS) with relapses
MedDRA version: 7.1;Level: LLT;Classification code 10028245
Trade Name: Rebif
Product Name: Rebif 8,8 µg, Rebif 22µg
INN or Proposed INN: Interferon beta-1 a
Trade Name: Rebif
Product Name: Rebif 44 µg
INN or Proposed INN: Interferon beta-1 a
Serono GmbHNULLNot RecruitingFemale: yes
Male: yes
100Phase 4Germany
12NCT01142518
(ClinicalTrials.gov)
July 200510/6/2010An Observational Study of Multiple Sclerosis (MS) Patients Starting or Restarting Baseline Treatment With Interferon Beta 1a After the Use of Escalation Treatment With MitoxantroneA Prospective Analysis of MS Patients After Starting or Restarting Baseline Treatment With Interferon Beta 1a After the Use of Escalation TreatmentRelapsing-Remitting Multiple SclerosisDrug: Interferon beta 1aMerck KGaANULLCompletedN/AN/ABoth86N/ANULL
13NCT00146159
(ClinicalTrials.gov)
March 20051/9/2005Study Evaluating Mitoxantrone in Multiple SclerosisA Double-Blind, Three-Armed, Randomized Phase-III-Study, to Compare the Efficacy, Tolerability and Safety of Three Doses of Mitoxantrone in the Treatment of Patients With Secondary Progressive Multiple SclerosisSecondary Progressive Multiple SclerosisDrug: MitoxantroneWyeth is now a wholly owned subsidiary of PfizerNULLTerminated18 Years55 YearsBoth336Phase 3Germany
14EUCTR2004-001601-10-IT
(EUCTR)
19/11/200415/03/2007MULTICENTTRIC, NATIONAL, SINGLE BLIND,CONTROLLED IN PARALLEL GROUP TO EVALUATE THE SAFETY AND EFFICACY OF THE SEQUENTIAL COMBINATION OF MITOXANTRONE AND BETA INTERFERON REBIF 44 mcg X 3 TIMES WEEKLY IN PATIENTS AFFECTED BY MULTIPLE SCLEROSIS, IN THE FIRST STEP OF THE DISEASEMULTICENTTRIC, NATIONAL, SINGLE BLIND,CONTROLLED IN PARALLEL GROUP TO EVALUATE THE SAFETY AND EFFICACY OF THE SEQUENTIAL COMBINATION OF MITOXANTRONE AND BETA INTERFERON REBIF 44 mcg X 3 TIMES WEEKLY IN PATIENTS AFFECTED BY MULTIPLE SCLEROSIS, IN THE FIRST STEP OF THE DISEASE MULTIPLE SCLEROSIS TREATMENT
MedDRA version: 6.1;Level: SOC;Classification code 10029205
Trade Name: NOVANTRONE*INF 2MG/ML 5ML
INN or Proposed INN: Mitoxantrone
Trade Name: REBIF*SC 12SIR 12000000UI44MCG
INN or Proposed INN: Interferon beta-1a
OSPEDALE S. RAFFAELENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
266France;Italy
15NCT00203073
(ClinicalTrials.gov)
June 200313/9/2005A Study to Evaluate the Safety and Effectiveness of Novantrone Therapy Followed by Copaxone for Multiple Sclerosis.A Multi-Center, Randomized, Open Label Study To Evaluate Safety, Tolerability And Efficacy Of Treatment With Mitoxantrone; Pre-Treatment With Glatiramer Acetate (GA) Versus Treatment With GA Alone In Relapsing Forms Of Multiple Sclerosis.Relapsing Remitting Multiple SclerosisDrug: glatiramer acetate 20 mg;Drug: glatiramer acetate 20 mg, with mitoxantroneTeva Pharmaceutical IndustriesNULLCompleted18 Years55 YearsBoth40Phase 2United States;Canada
16NCT00304291
(ClinicalTrials.gov)
August 200115/3/2006A Pilot Study of Mitoxantrone for the Treatment of Recurrent Neuromyelitis Optica (Devic’s Disease)A Pilot Study of Mitoxantrone for the Treatment of Recurrent Neuromyelitis Optica (Devic’s Disease)Neuromyelitis Optica;Myelitis, Transverse;Demyelinating Autoimmune Diseases, CNS;Autoimmune Diseases of the Nervous SystemDrug: MitoxantroneState University of New York at BuffaloEMD SeronoCompleted18 Years55 YearsBoth5Phase 4United States
17NCT00219908
(ClinicalTrials.gov)
July 199916/9/2005Evaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple SclerosisEvaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis: Induction Treatment With Mitoxantrone Followed by Long-Term Treatment With Interferon-beta1bRelapsing-Remitting Multiple SclerosisDrug: MitoxantroneRennes University HospitalBayer;Wyeth is now a wholly owned subsidiary of Pfizer;Farmades, ItalyTerminated18 Years45 YearsBoth124Phase 2France;Italy