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

NCT00526630 | Completed Phase 4 Results DMC

• 1 other identifier: 07-06-19-07
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson's Disease; Gait Impairment

Keywords

freezing; gait; festination; shuffling; balance

Outcome Measures

Primary Outcomes (2)

• The Primary Outcome Measure Was Change in a Gait Stride Length Between Groups at 12 and 27 Weeks.

  Gait stride length is the distance between two consecutive steps in the "on" state. This will be measured by the GAITRite System, which is an electronic walkway utilized to measure the temporal (timing) and spatial (two dimension geometric position) parameters of its pressure activated sensors.

  Week 12 and 27

• The Primary Outcome Measure Was Change in Gait Velocity Between Groups at 12 and 27 Weeks.

  Gait velocity is a measure of distance over time in the "on" state. This will be measured by the GAITRite System, which is an electronic walkway utilized to measure the temporal (timing) and spatial (two dimension geometric position) parameters of its pressure activated sensors.

  Week 12 and 27

Secondary Outcomes (6)

• The Unified Parkinson Disease Rating Scale (UPDRS) Between Groups at 12 and 27 Weeks

  At week 12 and 27

• Duration of Freezing and Shuffling Episodes Between Groups at 12 and 27 Weeks.

  Week 12 and 27

• Freezing of Gait Questionnaire (FOGQ) Scores Between Groups at 12 and 27 Weeks.

  Week 12 and 27

• Montgomery-Åsberg Depression Rating Scale (MADRS) Between Groups at 12 and 27 Weeks.

  Week 12 and 27

• The Epworth Sleepiness Scale (ESS) Between Groups at 12 and 27 Weeks

  Week 12 and 27

Study Arms (2)

1. MPD

ACTIVE COMPARATOR

Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.

Drug: Methylphenidate (MPD)

2. Placebo

PLACEBO COMPARATOR

Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.

Drug: Placebo

Interventions

Methylphenidate (MPD) DRUG

Participants will be given 1 mg/kg of MPD divided in three doses (at 8 am, 12 noon, and 4 pm). A four-week titration period will be used, using 0.25-mg/kg increments per week until achieving the weight-adjusted target dosage, which may range from five to eight 10-mg tablets per day. The maximum daily dose will be 80 mg/day.

Also known as: Ritalin

1. MPD

Placebo DRUG

Participants will be given placebo instead of active MPD.

2. Placebo

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cincinnati: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (1)

University Neurology-Movement Disorders Clinic

Cincinnati, Ohio, 45219, United States

Location

Related Publications (1)

• Espay AJ, Dwivedi AK, Payne M, Gaines L, Vaughan JE, Maddux BN, Slevin JT, Gartner M, Sahay A, Revilla FJ, Duker AP, Shukla R. Methylphenidate for gait impairment in Parkinson disease: a randomized clinical trial. Neurology. 2011 Apr 5;76(14):1256-62. doi: 10.1212/WNL.0b013e3182143537.

  PMID: 21464430 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Gait Disorders, Neurologic

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Alberto Espay, MD
• Organization: University of Cincinnati

alberto.espay@uc.edu

513-403-4600

Study Officials

• Alberto Espay, MD

  University of Cincinnati-Neurology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 5, 2007
• First Posted: September 10, 2007
• Study Start: December 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: April 22, 2015
• Results First Posted: April 22, 2015

Record last verified: 2015-04

Locations

US (1)