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Trial record 85 of 439 for:    Methylphenidate

TAME-PD - Physical Therapy, Atomoxetine and, Methylphenidate, to Enhance Gait and Balance in Parkinson's Disease (TAME-PD)

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ClinicalTrials.gov Identifier: NCT02879136
Recruitment Status : Recruiting
First Posted : August 25, 2016
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Shnehal Patel, The Cleveland Clinic

Brief Summary:
Gait and balance problems are a significant source of disability in patients with Parkinson disease. Physical therapy remains one of the main treatments. On the other hand some medications, such as methyphenidate and atomoxetine, have been tried with promising results. The outcomes in gait and balance in Parkinson disease after a combination of physical therapy and the medications mentioned above have not been explored yet. The investigators want to evaluate whether the addition of medication, either low dose of methylphenidate or atomoxetine, to physical therapy will achieve improvement in gait and balance in Parkinson disease more than physical therapy alone. The investigators propose a pilot, single center, rater blind, prospective randomized trial. 2-arm-parallel group, intention-to-treat analysis.

Condition or disease Intervention/treatment Phase
Parkinson's Disease, Idiopathic Drug: Methylphenidate Other: Physical Therapy Drug: Atomoxetine Early Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: TAME-PD - Physical Therapy, Atomoxetine and, Methylphenidate, to Enhance Gait and Balance in Parkinson's Disease: A Single Center, Randomized Pilot Study
Study Start Date : December 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Active Comparator: Physical Therapy
Physical Therapy (PT) will consist of two weekly sessions over a 12 week period using the Mellen center protocol PT for PD.
Other: Physical Therapy
All Patients will have standard of care PT used for PD patients
Other Name: PT

Active Comparator: Physical Therapy plus Methylphenidate
Methylphenidate 20 mg daily in combination with PT
Drug: Methylphenidate
Patient will be randomized to Methylphenidate
Other Name: Ritalin

Other: Physical Therapy
All Patients will have standard of care PT used for PD patients
Other Name: PT

Active Comparator: Physical Therapy plus Atomoxetine
Atomoxetine 10 mg daily in combination with PT or PT alone.
Other: Physical Therapy
All Patients will have standard of care PT used for PD patients
Other Name: PT

Drug: Atomoxetine
Patient will be randomized to Atomoxetine
Other Name: Straterra




Primary Outcome Measures :
  1. Balance Evaluation [ Time Frame: 12 weeks ]
    Change in the balance evaluation systems test, MiniBest is standard gait analysis measure conducted by physical therapists.


Secondary Outcome Measures :
  1. Change in gait [ Time Frame: 12 weeks ]
    Stride length and gait velocity measured using "GaitRite", which is a standard gait analysis measure conducted by physical therapists.


Other Outcome Measures:
  1. Motor function [ Time Frame: 12 weeks ]
    UPDRS part III scale



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with PD having significant balance or gait disorder with a score ≥2 in the Unified Parkinson Disease Rating Scale (UPDRS) 3.10 item 'independent walking but with substantial gait impairment; not related to off periods' occurring despite satisfactory motor control by dopaminergic therapy, with a medication regimen unlikely to change in the next 30 days.

Exclusion Criteria:

  • Previous participation in PD-specific PT.
  • Presence of signs and symptoms suggestive of atypical parkinsonism.
  • Concomitant conditions that may affect significantly the evaluation of balance or gait, including orthopedic, rheumatologic or other neurological diseases.
  • Contraindication for physical therapy
  • Comorbidities that contraindicate the use of the methylphenidate or atomoxetine: history of substance abuse, current severe anxiety, depression or psychosis, epilepsy, hyperthyroidism, glaucoma, cardiac arrhythmia, history of Tourette syndrome, hepatic disease, allergy to methylphenidate or atomoxetine.
  • Concurrent use of MAO inhibitors, or use in the last two weeks.
  • Previous deep brain stimulation procedure.
  • Punctuation of 5 in Hoehn and Yard modified scale: 'Wheelchair bound or bedridden unless aided'.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02879136


Contacts
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Contact: Shnehal Patel, MD patels7@ccf.org
Contact: Jennifer Mule mulej@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Shnehal Patel, MD       patels7@ccf.org   
Contact: Jennifer Mule, BS       mulej@ccf.org   
Sponsors and Collaborators
Shnehal Patel
Investigators
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Principal Investigator: Shnehal Patel The Cleveland Clinic

Publications:

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Responsible Party: Shnehal Patel, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02879136     History of Changes
Other Study ID Numbers: 16-277
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Shnehal Patel, The Cleveland Clinic:
Gait
Balance
PD
Additional relevant MeSH terms:
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Methylphenidate
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Atomoxetine Hydrochloride
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents