CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Ampyra first, then Placebo +1 moredrug
Likely dose
Ampyra 10 mg orally twice daily for 4 weeksAI-extracted
Key inclusion· 3
  • Idiopathic Parkinson's disease with Hoehn and Yahr stage 2–3, presenting with gait freezing or postural instability
  • On stable dosage of dopamine agonist or levodopa, expected to remain unchanged for duration of study
  • Age less than 80 years with disease onset after age 45
Key exclusion· 9
  • History of seizures
  • History of renal insufficiency
  • History of cardiac arrhythmia
  • Severe arthritis

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

Search/NCT01491022
NCT01491022Phase 2Completed

A Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's Disease

University of Miami·interventional·Posted Dec 13, 2011·Updated Jan 2, 2018

In Brief

A Phase 2 clinical trial evaluating Ampyra first, then Placebo and placebo first, then Ampyra for Parkinson's Disease. Completed, enrolled 22 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the effect of AMPYRA on a number of symptoms in Parkinson's disease. AMPYRA is a medication approved by FDA for gait dysfunction in multiple sclerosis. There are multiple studies to suggest that persons with multiple sclerosis benefit from this medication and have major improvements in gait after taking this medication. However, this medication was never studied in Parkinson's disease. This study aims to learn about possible benefits of AMPYRA in Parkinson's disease (PD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAcorda Therapeutics

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 13, 2011
Enrollment StartJul 1, 2012
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 14.6 years ago

Interventions

Ampyra first, then Placebodrug

10 mg po bid for 4 weeks followed by placebo 4 weeks.

placebo first, then Ampyradrug

placebo