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Efficacy Study of Amantadine to Treat Gait Dysfunction and Freezing in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01652534
Recruitment Status : Terminated (Low enrollment)
First Posted : July 30, 2012
Last Update Posted : March 29, 2017
Information provided by (Responsible Party):
Tanya Simuni, Northwestern University

Brief Summary:
The purpose of this study is to explore the efficacy of the drug Amantadine for the treatment of freezing of gait in patients with Parkinson's Disease. The investigators hypothesize that amantadine is useful for management of freezing of gait in subjects with Parkinson's Disease.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Amantadine Drug: Placebo Phase 3

Detailed Description:
Subjects who meet the eligibility requirements for the study will be randomized to Amantadine versus a matching placebo.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Amantadine for Gait Dysfunction and Gait Freezing in Patients With Parkinson's Disease
Study Start Date : June 2011
Actual Primary Completion Date : May 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Amantadine
Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day
Drug: Amantadine
Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day. Amantadine will then be administered orally twice daily in the morning with breakfast and at noon with lunch (AM and NN).
Other Name: Symmetrel

Placebo Comparator: placebo
Sugar Pill
Drug: Placebo
Sugar Pill
Other Name: Sugar Pill

Primary Outcome Measures :
  1. Timed Up and Go (TUG) [ Time Frame: Baseline, week 4, week 7 and week 11 ]
    This is a walking assessment. The subject will begin in the seated position, stand up, walk 7 meters, turn around, and sit back down. The entire process from leaving the chair to returning to the chair will be timed. Also, the Timed Up and Go (TUG) will be done both in the ON and OFF states.

Secondary Outcome Measures :
  1. modified Timed Up and Go (mTUG) [ Time Frame: Baseline, week 4, week 7, week 11 ]
    The subject sits in the chair approximately 3 1/2 meters away from doorway with the door closed. Subject then stands up and walks one meter to a 40cm X 40cm box taped on the floor. Within the box the patient turns clockwise (360 degrees), then turns counterclockwise (360 degrees). Walk to open the door and walk through the doorway, turn around and return to the chair. Modified Timed Up and Go (mTUG) completed in three components including walking the course without additional tasks, carrying a tray with a cup of water, and counting backwards from 100, in both ON and OFF state.

  2. Analysis of Motor Functioning using the Parkinson's Home Diaries [ Time Frame: Baseline, week 4, week 7, week 11 ]
    Subject will record motor activity as OFF, ON (mobility improved) or asleep on the diary every half hour for two days. Subjects further define ON time according to dyskinesia categories "none", "non-troublesome" or "troublesome." The home diaries are used as an evaluation measure of the intervention by assessing the change in off time and change in on time with troublesome dyskinesia. This provides a more accurate reflection of clinical response than change in off time alone.

  3. Freezing of Gait Questionnaire [ Time Frame: Baseline, week 4, week 7, week 11 ]
    A questionnaire that is used to assess the likelihood of the subject freezing in a number of different scenarios.

  4. Clinical Global Impression (CGI) [ Time Frame: Baseline, week 4, week 7, week 11 ]
    Global Improvement is the second scale in the clinical global impression (CGI). Total overall improvement is judged by whether or not, in the judgment of the assessor, the improvement is entirely due to the drug treatment. It is also a 1-7 point weighted scale, going from "very much improved" (1) to "very much worse" (7). A zero score is assigned if the score is not assessed.

  5. Parkinson's Disease Questionnaire-39 (PDQ-39) [ Time Frame: Baseline, week 4, week 7, week 11 ]
    The Parkinson's Disease Questionnaire-39 (PDQ39) is a copyrighted instrument to assess symptoms of Parkinson's disease (PD) with 39 questions relating to mobility, activities of daily living, emotional well-being, social support, cognition, communication and bodily discomfort. The test asks subjects to rate each question regarding their Parkinson's disease symptoms over the past month.

  6. Gait Analysis Testing [ Time Frame: Baseline, week 4, week 7, week 11 ]
    Use of an accelerometer such as Motorola Droid and wireless acceleration sensors to record gait parameters step time, walking speed, and cadence during the timed up and go (TUG) and modified timed up and go (mTUG) components. The sensors will be attached to the subject's legs and trunk using Velcro straps. The accelerometer will be held or clipped onto the subject in order to measure his or her acceleration. This is done within clinic and during the visit time.

  7. Fatigue Severity Scale (FSS) [ Time Frame: Baseline, Week 4, Week 7, Week 11 ]
    A questionnaire used to discriminate between Parkinson Disease (PD) patients with fatigue and those without fatigue.

  8. Tolerability [ Time Frame: Baseline, Week 4, Week 7, Week 11 ]
    Tolerability analysis as determined by the number of subjects completing each arm of the study.

  9. Drug Safety and Tolerability Analysis [ Time Frame: Baseline, Week 4, Week 7, Week 11 ]
    Analyzing the safety of the medication, Amantadine. Data regarding the medication will be collected from the patient on each visit including any adverse events since the last visit, frequency and severity of falls. This is done in order to determine the safety of Amantadine.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subjects with idiopathic PD as determined by UK brain bank diagnostic criteria
  2. H&Y stage 2.5-3
  3. Presence of freezing of gait (FOG) as determined by UPDRS Part I score > 2
  4. Ability to walk for 2 minutes in the ON and OFF state
  5. Stable regimen of PD medications for 30 days prior to screening
  6. Ability to comply with the study procedures
  7. If female, be either post menopausal for at least 2 years, surgically sterilized or have undergone hysterectomy or, if of child bearing potential they must be willing to avoid pregnancy by using an adequate method of contraception as defined in Section 6.4.10 for four weeks prior to, during and four weeks after the last dose of trial medication. For the purposes of this trial, women of childbearing potential are defined as all female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive.
  8. Willing and able to provide informed consent.

Exclusion Criteria:

  1. Presence of other co morbid conditions that can contribute to gait dysfunction (orthopedic, rheumatologic, cardiac, other)
  2. Presence of freezing of gait (FOG) ONLY in medications ON state
  3. Presence of freezing of gait (FOG) ONLY in medications OFF state
  4. Presence of significant cognitive dysfunction as determined by Montreal Cognitive Assessment (MoCA) <20
  5. Presence of clinically significant depression as determined by geriatric depression scale (GDS)- 15>5
  6. Presence of clinically significant hallucinations
  7. Inability to sign informed consent
  8. Participation in the physical therapy aimed at management of PD for the duration of the study (PT for orthopedic issues will be allowed)
  9. Contraindications for use of Amantadine ( prior history of allergic reaction, history of known renal insufficiency with Cr > 2)
  10. If female, be pregnant or lactating

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 identifier (NCT number): NCT01652534

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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
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Principal Investigator: Tanya Simuni, MD Northwestern University

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Responsible Party: Tanya Simuni, Professor of Neurology Director, Parkinson's Disease and Movement Disorders Center, Northwestern University Identifier: NCT01652534     History of Changes
Other Study ID Numbers: M012010
First Posted: July 30, 2012    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Tanya Simuni, Northwestern University:
Freezing of gait
gait dysfunction
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Antiparkinson Agents
Anti-Dyskinesia Agents
Antiviral Agents
Anti-Infective Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents