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NCT01786174 · ClinicalTrials.gov registry record · Phase 2

Gilenya in Amyotrophic Lateral Sclerosis (ALS)

A Phase 2 study, sponsored by Massachusetts General Hospital.

Completed
Registry status
Phase 2
Development phase
30
Enrollment target

NCT01786174: Completed Phase 2 study, sponsored by Massachusetts General Hospital.

NCT01786174 is a Phase 2 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01786174, a Phase 2 study, has completed, sponsored by Massachusetts General Hospital.

COMPLETED
Registry status
Phase 2
Development phase
30 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether Gilenya, also known as fingolimod, is safe and tolerable in patients with Amyotrophic Lateral Sclerosis (ALS).

Primary Outcome

The ALSFRS-R is a quickly administered (5 minutes) ordinal rating scale (ratings 0-4) used to determine subjects' assessment of their capability and independence in 12 functional activities. All 12 activities are relevant in ALS. Initial validity was established by documenting that in ALS patients, change in ALSFRS-R scores correlated with change in strength over time, was closely associated with quality of life measures, and predicted survival.

Interventions

  • OTHER Placebo
  • DRUG Gilenya

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2013-08
Est. Completion 2015-05
Phase Phase 2
Massachusetts General Hospital

2,032 total trials

What the finished NCT01786174 record still lists

NCT01786174 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01786174 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01786174 about?

NCT01786174 is a clinical study titled "Gilenya in Amyotrophic Lateral Sclerosis (ALS)". The purpose of this study is to determine whether Gilenya, also known as fingolimod, is safe and tolerable in patients with Amyotrophic Lateral Sclerosis (ALS).

What is the current status of trial NCT01786174?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2013-08. Estimated completion is 2015-05.

What interventions are being tested in trial NCT01786174?

The interventions under investigation include: Placebo (OTHER), Gilenya (DRUG).

Who is sponsoring clinical trial NCT01786174?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01786174's enrollment target sits among peer trials

30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01786174, the US trial registry maintained by the National Library of Medicine. NCT01786174 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.