Phase 4 N=23 Randomized Quadruple-blind Treatment

Methylphenidate for the Treatment of Gait Impairment in Parkinson's Disease

Parkinson's Disease · Gait Impairment

Bottom Line

View on ClinicalTrials.gov: NCT00526630 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2015

Primary outcome: Primary: The Primary Outcome Measure Was Change in a Gait Stride Length Between Groups at 12 and 27 Weeks. — 107.66; 112.29; 103.35 centimeters

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Methylphenidate (MPD) (Drug); Placebo (Drug)
Age: Adult, Older Adult · 35+ yrs
Sex: All
Sponsor: University of Cincinnati
Primary completion: Oct 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY The Primary Outcome Measure Was Change in a Gait Stride Length Between Groups at 12 and 27 Weeks.	107.66; 112.29; 103.35	—
PRIMARY The Primary Outcome Measure Was Change in Gait Velocity Between Groups at 12 and 27 Weeks.	96.96; 99.24; 95.76	—
SECONDARY The Unified Parkinson Disease Rating Scale (UPDRS) Between Groups at 12 and 27 Weeks	21.18; 20.33; 18.39	—
SECONDARY Duration of Freezing and Shuffling Episodes Between Groups at 12 and 27 Weeks.	7.67; 6.15; 9.1; 3.07; 3.25; 5.4	—
SECONDARY Freezing of Gait Questionnaire (FOGQ) Scores Between Groups at 12 and 27 Weeks.	12.31; 12.56; 12.71	—
SECONDARY Montgomery-Åsberg Depression Rating Scale (MADRS) Between Groups at 12 and 27 Weeks.	5.79; 6.71; 9.44	—
SECONDARY The Epworth Sleepiness Scale (ESS) Between Groups at 12 and 27 Weeks	11.05; 10.71; 11.24	—
SECONDARY The 5-item EuroQoL (EQ-5D) Quality of Life Generic Instrument Between Groups at 12 and 27 Weeks.	65; 63.94; 68.67	—

Summary

The purpose of this research study is to examine whether Methylphenidate (MPD) can result in improvement of gait (walking) in a population of Parkinson's Disease (PD) patients whose main disability is freezing of gait. MPD (Ritalin®) is a drug which can excite or stimulate certain systems of the body that control motor function. This drug is FDA approved for the treatment of attention hyperactivity disorder, a condition unrelated to PD. The researchers hypothesize that daily treatment with a tolerable daily oral dose of MPD will improve gait velocity, stride length, cadence, and decrease freezing of gait, 3 months from treatment initiation in patients with moderately advanced PD, whose gait impairment is an important source of disability despite optimized antiparkinsonian treatment.

Eligibility Criteria

Inclusion Criteria

Patients with a definite diagnosis of Parkinson's disease for at least 5 years.
Patients with mild to severe gait disturbance.
Patients on a stable dose of anti-parkinsonian medications that will not be expected to require medication adjustments.
Mini-Mental State Examination (MMSE) score of 25 or greater.

Exclusion Criteria

Patients with musculoskeletal disorders such as severe arthritis, post knee surgery, hip surgery, or any other condition that the investigators determine may impair assessment of gait.
Previous treatment with DBS (deep brain stimulation).
Those with history of stroke.
Those with cerebellar, vestibular, or sensory ataxia.
Concurrent use of, or within two weeks from discontinuing, MAO inhibitor drugs (selegiline, rasagiline).
Women of childbearing potential.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00526630). 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.