Efficacy Study of Amantadine to Treat Gait Dysfunction and Freezing in Parkinson's Disease
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.
|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|
- 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.
- 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.
|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)|
|Active Comparator: 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||
Subjects who meet the eligibility requirements for the study will be randomized to Amantadine versus a matching placebo.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01652534
|Contact: C. Danielle Tan, BSfirstname.lastname@example.org|
|Contact: Karen Williams, BAemail@example.com|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Contact: C. Danielle Tan, BS 312-503-1999 firstname.lastname@example.org|
|Contact: Karen Williams, BA 312-503-5645 email@example.com|
|Principal Investigator: Tanya Simuni, MD|
|Sub-Investigator: Mark Shapiro, PhD|