Fingolimod (FTY720) in Acute Demyelinating Optic Neuritis (ADON)

Novartis

Status and phase: Terminated; Phase 2

Conditions: Acute Demylelinating Optic Neuritis

Treatments: Drug: Fingolimod 0.5mg/daily; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01757691

CFTY720D2402

2012-002968-27 (EudraCT Number)

Details and patient eligibility

About

To evaluate the efficacy and safety of fingolimod 0.5mg versus placebo in patients with suspected acute demyelinating optic neuritis (ADON) receiving standard steroid treatment

Enrollment: 2 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical signs and symptoms of ADON in one eye (loss of vision, pain on movement, impairment of color vision)
• First episode of ADON
• Able to undergo treatment with IV steroids

Exclusion criteria

• History of any unexplained eye or neurological symptoms lasting longer than 48 hours

• Optic neuritis in both eyes

• Concomitant condition in either eye, other than optic neuritis

• History of heart condition/disease

• Patients with uncontrolled diabetes mellitus

• Patients with liver conditions/disease

• Inability to undergo MRI

• Pregnant or nursing women

• Women of childbearing potential who are not using highly effective method of birth control

  • Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2 participants in 2 patient groups, including a placebo group

Fingolimod 0.5mg/daily

Experimental group

Description:

Oral capsule dose was given once daily for 48 weeks

Treatment:

Drug: Fingolimod 0.5mg/daily

Placebo

Placebo Comparator group

Description:

Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48

Treatment:

Drug: Placebo