Phase 2 N=22 Randomized Quadruple-blind Treatment

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

Parkinson's Disease

Bottom Line

View on ClinicalTrials.gov: NCT01491022 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2017

Primary outcome: Primary: Change in Velocity — 0.03; 0.05 m/s

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Ampyra first, then Placebo (Drug); placebo first, then Ampyra (Drug)
Age: Adult, Older Adult · 45+ yrs
Sex: All
Sponsor: University of Miami
Primary completion: Jul 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Velocity	0.03; 0.05	—
SECONDARY United Parkinson's Disease Rating Scale Score(UPDRS) ,	35.22; 35.55	—
SECONDARY Freezing of Gait Questionnaire (FOGQ)	13.16; 13.4	—
SECONDARY Timed Up and Go (TUG) Score	23.25; 20.6	—
SECONDARY Timed 25-foot Walk Test (T25FW)	11.6; 11.8	—
SECONDARY Change in Stride Legth	-0.01; 0.05	—

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).

Eligibility Criteria

Inclusion Criteria

Idiopathic PD with stage Hoehn and Yahr Stage>2-3 and with gait freezing or postural instability.
On stable dosage dopamine agonist/levodopa, and expected to remain on the same dosage of treatment for the duration of study
Age less than 80, onset of disease at age more than 45.
Able to give consent

Exclusion Criteria

Past medical history of seizures,
History of renal insufficiency,
History of cardiac arrhythmia,
Severe arthritis,
Women of childbearing potential,
Cognitive impairment
Age more than 80.
PD patients stage 4 H&Y
PD patient with recent introduction of dopamine agonist or IMAO B
PD patients participating in other studies

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01491022). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.