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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01874340
Other study ID # CAIN457B2203
Secondary ID 2012-004019-29
Status Terminated
Phase Phase 2
First received May 28, 2013
Last updated May 14, 2015
Start date June 2013
Est. completion date April 2014

Study information

Verified date May 2015
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsCanada: Health CanadaColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosCzech Republic: State Institute for Drug ControlFinland: Finnish Medicines AgencyFrance: ANSM: National Agency for the Safety of MedicineJapan: Pharmaceuticals and Medical Devices AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Medicines AgencySpain: Agencia Española de Medicamentos y Productos SanitariosSweden: Medical Products AgencySwitzerland: SwissmedicTurkey: Turkish Republic Ministry of Health, Turkish Pharmaceuticals and Medical Devices AgencyGermany: Paul-Ehrlich-InstitutItaly: The Italian Medicines AgencyPortugal: Instituto Nacional de Farmacia e do Medicamento (INFARMED)Russia: Ministry of Health of the Russian Federation
Study type Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of AIN457 versus placebo in patients with relapsing multiple sclerosis.


Recruitment information / eligibility

Status Terminated
Enrollment 28
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Diagnosis of Multiple Sclerosis according to 2010 revised McDonald criteria

- Disease duration of 10 years or less

- At least one relapse in the last year

- EDSS score 0 to 5.0 at entry

Exclusion Criteria:

- Active chronic disease of the immune system other than multiple sclerosis

- History of malignancy within the past 5 years

- Active systemic bacterial, viral or fungal infections

- Previous treatment with more than one class of multiple sclerosis therapies except for previous treatment with glatiramer acetate and interferon-beta(s)

- Any medically unstable condition

- Unable to undergo MRI scans or repeated blood tests

- Pregnant or nursing females

- Women of child-bearing potential must use reliable forms of contraception

- Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Placebo
Placebo will be administered at predefined visits over the 6-month treatment phase.
AIN457
AIN457 will be administered at predefined visits over the 6-month treatment phase.

Locations

Country Name City State
Belgium Novartis Investigative Site Brugge
Czech Republic Novartis Investigative Site JIhlava
France Novartis Investigative Site St Herblain
Italy Novartis Investigative Site Roma RM
Japan Novartis Investigative Site Osaka-city Osaka
Poland Novartis Investigative Site Lodz
Poland Novartis Investigative Site Poznan
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Saint-Petersburg
Spain Novartis Investigative Site Barcelona Catalunya
Spain Novartis Investigative Site Bilbao Pais Vasco
Sweden Novartis Investigative Site Stockholm
Turkey Novartis Investigative Site Atakum / Samsun

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Belgium,  Czech Republic,  France,  Italy,  Japan,  Poland,  Russian Federation,  Spain,  Sweden,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cumulative Number of New Gadolinium [Gd]-Enhancing T1-weighted Lesions Due to early termination this trial was not powered for efficacy no statistical analysis was performed Months 3, 4, 5, 6 No
Secondary Annualized Relapse Rate Due to early termination this trial was not powered for efficacy no statistical analysis was performed 6 Months No
Secondary Combined Unique Active Lesions (CUAL) Due to early termination this trial was not powered for efficacy no statistical analysis was performed Months 3, 4, 5, 6 No
Secondary Change in Total Volume of T2-weighted Lesions Due to early termination this trial was not powered for efficacy no statistical analysis was performed Baseline, Month 6 No
Secondary Number of Particpants With Adverse Events as a Measure of Safety and Tolerability Number of particpants with Adverse events as a measure of safety and tolerability 6 months Yes
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