CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 80 enrolled
Drug / intervention
Rasagiline +1 moredrug
Likely dose
Rasagiline 2mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01786603
NCT01786603Phase 2Completed

Phase 2 Study of Rasagiline for Treatment of Amyotrophic Lateral Sclerosis

Richard Barohn, MD·interventional·Posted Feb 8, 2013·Updated Jan 27, 2020

In Brief

A Phase 2 clinical trial evaluating Rasagiline and Placebo for Amyotrophic Lateral Sclerosis (ALS). Completed, enrolled 80 participants across 10 sites.

Detailed Summary

ALS is a disorder that weakens motor strength and lung function. Rapid loss of motor neurons in the brain and spinal cord of ALS patients causes the symptoms of increasing weakness and loss of muscle function. Motor neurons are responsible for sending signals to muscles in our bodies to trigger movement. While there are drugs to help relieve symptoms of ALS, there is no cure for ALS. Rasagiline is a drug with possible neuroprotective characteristics. Neuroprotective means that the nervous system may be protected against weakening. It is known that rasagiline has possible neuroprotective characteristics, but the effectiveness of rasagiline for patients with ALS has not been tested. Rasagiline is approved for the treatment of Parkinson's disease. Rasagiline for treatment of ALS is not approved by the U.S. Food and Drug Administration (FDA) and is investigational. Investigational drugs are studied to find out if they are safe and effective in the treatment of diseases or conditions. By doing this study, researchers hope to learn if rasagiline is safe and slows disease progression in patients with ALS. Funding Source - FDA OOPD (FDA Orphan Products Division).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 8, 2013
Enrollment StartNov 21, 2013
Primary CompletionJul 27, 2016
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 13.4 years ago

Interventions

Rasagilinedrug

Rasagiline 2mg once a day for 12 months.

Placebodrug

Placebo (looks like study drug but has no active ingredients) once a day for 12 months.