Trials / Completed
CompletedNCT01625182
Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients.
A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Fingolimod 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 106 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The study was designed to evaluate the efficacy and safety of fingolimod in the treatment of chronic inflammatory demyelinating polyradiculoneuropathy compared with placebo.
Detailed description
This study was a double-blind, randomized, multicenter, placebo-controlled, parallel-group study in patients with a diagnosis of chronic inflammatory demyelinating polyradiculoneuropathy and treated with IVIg, corticosteroids, or both therapies prior to study entry. Patients meeting the eligibility criteria were randomly assigned in a ratio of 1:1 to receive oral fingolimod (0.5 mg/day) or matching placebo. The study consisted of 3 periods: a Screening Period, a Double-blind Treatment Period and a Follow-up Period after discontinuation of study drug treatment. Patients who complete the study will have an option to enter an extension.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fingolimod | Fingolimod 0.5 mg capsules |
| DRUG | Placebo Comparator | Matching placebo capsules |
Timeline
- Start date
- 2012-12-22
- Primary completion
- 2016-09-03
- Completion
- 2016-09-03
- First posted
- 2012-06-21
- Last updated
- 2017-10-30
- Results posted
- 2017-09-19
Locations
67 sites across 15 countries: United States, Australia, Belgium, Canada, Czechia, France, Germany, Greece, Israel, Italy, Japan, Netherlands, Poland, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01625182. Inclusion in this directory is not an endorsement.