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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
Tanya Simuni, Northwestern University
ClinicalTrials.gov Identifier:
NCT01652534
First received: August 15, 2011
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Parkinson's Disease
Drug: Amantadine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Amantadine for Gait Dysfunction and Gait Freezing in Patients With Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Timed Up and Go (TUG) [ Time Frame: Baseline, week 4, week 7 and week 11 ] [ Designated as safety issue: No ]
    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:
  • modified Timed Up and Go (mTUG) [ Time Frame: Baseline, week 4, week 7, week 11 ] [ Designated as safety issue: No ]
    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.

  • Analysis of Motor Functioning using the Parkinson's Home Diaries [ Time Frame: Baseline, week 4, week 7, week 11 ] [ Designated as safety issue: No ]
    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.

  • Freezing of Gait Questionnaire [ Time Frame: Baseline, week 4, week 7, week 11 ] [ Designated as safety issue: No ]
    A questionnaire that is used to assess the likelihood of the subject freezing in a number of different scenarios.

  • Clinical Global Impression (CGI) [ Time Frame: Baseline, week 4, week 7, week 11 ] [ Designated as safety issue: No ]
    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.

  • Parkinson's Disease Questionnaire-39 (PDQ-39) [ Time Frame: Baseline, week 4, week 7, week 11 ] [ Designated as safety issue: No ]
    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.

  • Gait Analysis Testing [ Time Frame: Baseline, week 4, week 7, week 11 ] [ Designated as safety issue: No ]
    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.

  • Fatigue Severity Scale (FSS) [ Time Frame: Baseline, Week 4, Week 7, Week 11 ] [ Designated as safety issue: No ]
    A questionnaire used to discriminate between Parkinson Disease (PD) patients with fatigue and those without fatigue.

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

  • Drug Safety and Tolerability Analysis [ Time Frame: Baseline, Week 4, Week 7, Week 11 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 15
Study Start Date: June 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Amantadine 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).
Placebo Comparator: placebo Drug: Placebo
Sugar Pill

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01652534

Contacts
Contact: C. Danielle Tan, BS 312-503-1999 l-wulf@northwestern.edu
Contact: Karen Williams, BA 312-503-5645 k-williams8@northwestern.edu

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: C. Danielle Tan, BS    312-503-1999    c.danielle.tan@northwestern.edu   
Contact: Karen Williams, BA    312-503-5645    k-williams8@northwestern.edu   
Principal Investigator: Tanya Simuni, MD         
Sub-Investigator: Mark Shapiro, PhD         
Sponsors and Collaborators
Northwestern University
  More Information

No publications provided

Responsible Party: Tanya Simuni, Professor of Neurology Director, Parkinson's Disease and Movement Disorders Center, Northwestern University
ClinicalTrials.gov Identifier: NCT01652534     History of Changes
Other Study ID Numbers: M012010
Study First Received: August 15, 2011
Last Updated: August 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Freezing of gait
gait dysfunction

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Amantadine
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 14, 2014