Trial Outcomes & Findings for Fingolimod (FTY720) in Acute Demyelinating Optic Neuritis (ADON) (NCT NCT01757691)

Results Overview

Due to early termination and low patient enrollment the primary outcome measure was not analyzed

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

Baseline and Week 18

Results posted on

2015-05-04

Participant Flow

Participant milestones

Participant milestones
Measure	Fingolimod 0.5mg/Daily Oral capsule dose was given once daily for 48 weeks	Placebo Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
Overall Study STARTED	2	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Fingolimod 0.5mg/Daily Oral capsule dose was given once daily for 48 weeks	Placebo Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
Overall Study Administrative problems	2	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fingolimod 0.5mg/Daily n=2 Participants Oral capsule dose was given once daily for 48 weeks
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	2 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline and Week 18

Due to early termination and low patient enrollment the primary outcome measure was not analyzed

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 48

Due to early termination and low patient enrollment this trial was not powered for efficacy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 18, Week 48

Due to early termination and low patient enrollment this trial was not powered for efficacy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 18, Week 48

Due to early termination and low patient enrollment this trial was not powered for efficacy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Weeks 0, 4, 8, 12, 18, 24, 36, 48, 60

Population: Safety population consited of all patients who received at least one dose of study medication

Number of particpants with Adverse events as a measure of safety and tolerability

Outcome measures

Outcome measures
Measure	Fingolimod 0.5mg/Daily n=2 Participants Oral capsule dose was given once daily for 48 weeks	Placebo Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
Number of Particpants With Adverse Events as a Measure of Safety and Tolerability Adverse Events (AE)	1 Participants	—
Number of Particpants With Adverse Events as a Measure of Safety and Tolerability Death	0 Participants	—
Number of Particpants With Adverse Events as a Measure of Safety and Tolerability Non -Fatal Seriuos Aderse Event (SAE)	0 Participants	—

Adverse Events

Fingolimod 0.5mg/Daily

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Fingolimod 0.5mg/Daily n=2 participants at risk Oral capsule dose was given once daily for 48 weeks	Placebo Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
Gastrointestinal disorders Vomiting	50.0% 1/2 Safety population consited of all patients who received at least one dose of study medication	— 0/0 Safety population consited of all patients who received at least one dose of study medication
Infections and infestations Nasopharyngitis	50.0% 1/2 Safety population consited of all patients who received at least one dose of study medication	— 0/0 Safety population consited of all patients who received at least one dose of study medication
Respiratory, thoracic and mediastinal disorders ASTHMA EXACERBATION	50.0% 1/2 Safety population consited of all patients who received at least one dose of study medication	— 0/0 Safety population consited of all patients who received at least one dose of study medication

Additional Information

Study Director

Novartis

Phone: 862-778-8300

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis doesn not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of the pooled data (i.e. data from all sites) in the clinical trial or disclosure of the trial results in their entirety.
Publication restrictions are in place

Restriction type: OTHER