- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01652534
Efficacy Study of Amantadine to Treat Gait Dysfunction and Freezing in Parkinson's Disease
October 23, 2019 updated by: Tanya Simuni, Northwestern University
Efficacy of Amantadine for Gait Dysfunction and Gait Freezing in Patients With 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 Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Subjects who meet the eligibility requirements for the study will be randomized to Amantadine versus a matching placebo.
Study Type
Interventional
Enrollment (Actual)
3
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects with idiopathic PD as determined by UK brain bank diagnostic criteria
- H&Y stage 2.5-3
- Presence of freezing of gait (FOG) as determined by UPDRS Part I score > 2
- Ability to walk for 2 minutes in the ON and OFF state
- Stable regimen of PD medications for 30 days prior to screening
- Ability to comply with the study procedures
- 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.
- Willing and able to provide informed consent.
Exclusion Criteria:
- Presence of other co morbid conditions that can contribute to gait dysfunction (orthopedic, rheumatologic, cardiac, other)
- Presence of freezing of gait (FOG) ONLY in medications ON state
- Presence of freezing of gait (FOG) ONLY in medications OFF state
- Presence of significant cognitive dysfunction as determined by Montreal Cognitive Assessment (MoCA) <20
- Presence of clinically significant depression as determined by geriatric depression scale (GDS)- 15>5
- Presence of clinically significant hallucinations
- Inability to sign informed consent
- Participation in the physical therapy aimed at management of PD for the duration of the study (PT for orthopedic issues will be allowed)
- Contraindications for use of Amantadine ( prior history of allergic reaction, history of known renal insufficiency with Cr > 2)
- If female, be pregnant or lactating
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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
|
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 Names:
|
Placebo Comparator: placebo
Sugar Pill
|
Sugar Pill
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Timed Up and Go (TUG) - ON Usual Medication
Time Frame: Baseline, change at 4 weeks
|
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.
|
Baseline, change at 4 weeks
|
Timed Up and Go (TUG) - OFF Usual Medication
Time Frame: Baseline, change at 4 weeks
|
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.
|
Baseline, change at 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Timed Up and Go (mTUG)
Time Frame: Baseline, change in 4 weeks
|
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.
|
Baseline, change in 4 weeks
|
Analysis of Motor Functioning Using the Parkinson's Home Diaries
Time Frame: Baseline, change in 4 weeks
|
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.
The difference in time experiencing dyskinesia while ON meds relative to the time OFF meds at baseline and at 4 weeks is compared.
|
Baseline, change in 4 weeks
|
Freezing of Gait Questionnaire
Time Frame: Baseline, change in 4 weeks
|
A questionnaire that is used to assess the likelihood of the subject freezing in a number of different scenarios. 0=No freezing of gait to 24=severe freezing of gait |
Baseline, change in 4 weeks
|
Clinical Global Impression (CGI)
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Parkinson's Disease Questionnaire-39 (PDQ-39)
Time Frame: Baseline, week 4
|
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.
(range 0 to 100, lower scores reflect better quality of life)
|
Baseline, week 4
|
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.
|
Baseline, week 4, week 7, week 11
|
Fatigue Severity Scale (FSS)
Time Frame: Baseline, change in 4 weeks
|
A questionnaire used to discriminate between Parkinson Disease (PD) patients with fatigue and those without fatigue.
Range 9 to 63, higher scores indicate greater fatigue severity.
|
Baseline, change in 4 weeks
|
Number Who Completed Medication as Randomized
Time Frame: week 4
|
Tolerability analysis as determined by the number of subjects completing each arm of the study.
|
week 4
|
Number of Participants With Drug Safety Reports
Time Frame: Week 4
|
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.
|
Week 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
August 15, 2011
First Submitted That Met QC Criteria
July 27, 2012
First Posted (Estimate)
July 30, 2012
Study Record Updates
Last Update Posted (Actual)
November 13, 2019
Last Update Submitted That Met QC Criteria
October 23, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Dopamine Agents
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Amantadine
Other Study ID Numbers
- M012010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parkinson's Disease
-
Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
-
Assistance Publique - Hôpitaux de ParisFrance Parkinson AssociationUnknownHealthy Controls | Parkinson's Disease With LRRK2 Mutation | Parkinson's Disease Without LRRK2 MutationFrance
-
Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
-
Universidade Federal de PernambucoCompletedParkinson's Disease.Brazil
-
University Hospital, GrenobleCompletedParkinson's Disease (Disorder)France
-
Neurocrine BiosciencesVoyager TherapeuticsCompletedBrain Diseases | Central Nervous System Diseases | Nervous System Diseases | Parkinson's Disease | Parkinsonian Disorders | Movement Disorders | Neurodegenerative Diseases | Idiopathic Parkinson's Disease | Basal Ganglia DiseaseUnited States
-
Second Affiliated Hospital of Soochow UniversityShanghai Regenelead Therapies Co., Ltd.RecruitingAdvanced Parkinson's DiseaseChina
-
AbbVieRecruitingParkinson's Disease (PD)Germany, Denmark, Spain
-
Beijing Tiantan HospitalRecruitingPD - Parkinson's DiseaseChina
-
Hubert FernandezRecruitingParkinson's Disease, IdiopathicUnited States
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States