Parkinson's DiseasePhase 3NCT01652534
Efficacy Study of Amantadine to Treat Gait Dysfunction and Freezing in Parkinson's Disease
A Phase 3 study testing Amantadine in people with Parkinson's Disease, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Amantadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Aug 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
Subjects who meet the eligibility requirements for the study will be randomized to Amantadine versus a matching placebo.
- Conditions
- Parkinson's Disease
- Being tested
- Amantadine, Placebo
- Keywords
- Freezing of gait, gait dysfunction
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmantadineDrug
Also called Symmetrel
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).
PlaceboDrug
Also called Sugar Pill
Sugar Pill
| Study group | Role | What they receive |
|---|---|---|
| Amantadine | Active comparator | Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day Receives: Drug: Amantadine |
| placebo | Placebo comparator | Sugar Pill Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go (TUG) - ON Usual Medication
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.
Measured: Baseline, change at 4 weeks
Timed Up and Go (TUG) - OFF Usual Medication
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.
Measured: Baseline, change at 4 weeks
Secondary outcomes (9)
Modified Timed Up and Go (mTUG)
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.
Measured: Baseline, change in 4 weeks
Analysis of Motor Functioning Using the Parkinson's Home Diaries
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.
Measured: Baseline, change in 4 weeks
Freezing of Gait Questionnaire
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
Measured: Baseline, change in 4 weeks
Clinical Global Impression (CGI)
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.
Measured: 4 weeks
Parkinson's Disease Questionnaire-39 (PDQ-39)
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)
Measured: Baseline, week 4
Gait Analysis Testing
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.
Measured: Baseline, week 4, week 7, week 11
Fatigue Severity Scale (FSS)
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.
Measured: Baseline, change in 4 weeks
Number Who Completed Medication as Randomized
Tolerability analysis as determined by the number of subjects completing each arm of the study.
Measured: week 4
Number of Participants With Drug Safety Reports
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.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startJun 2011
- Primary completionMay 2015
- Study completionAug 2015
Why it stopped: Due to lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanya Simuni, Northwestern University
- Investigators
- Tanya Simuni, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652534
- Sponsor's protocol ID
- M012010
- Status last verified
- Oct 2019
- First submitted
- 15 Aug 2011
- Last updated
- 13 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Amantadine for Gait Dysfunction and Gait Freezing in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01652534
- Acronym / sponsor ID
- M012010
- Conditions
- Parkinson's Disease
- Keywords
- Freezing of gait, gait dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to lack of recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- May 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 30 Jul 2012 (estimated)
- Results
- Posted 13 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subjects who meet the eligibility requirements for the study will be randomized to Amantadine versus a matching placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amantadine | Active comparator | Drug: AmantadineAmantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day |
| placebo | Placebo comparator | Drug: PlaceboSugar Pill |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmantadineAlso: SymmetrelAmantadine 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). | Drug | Amantadine |
| PlaceboAlso: Sugar PillSugar Pill | Drug | placebo |
Primary outcome
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.
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.
9 secondary outcomes
Modified Timed Up and Go (mTUG)
Time frame: Baseline, change in 4 weeks
Analysis of Motor Functioning Using the Parkinson's Home Diaries
Time frame: Baseline, change in 4 weeks
Freezing of Gait Questionnaire
Time frame: Baseline, change in 4 weeks
Clinical Global Impression (CGI)
Time frame: 4 weeks
Parkinson's Disease Questionnaire-39 (PDQ-39)
Time frame: Baseline, week 4
Gait Analysis Testing
Time frame: Baseline, week 4, week 7, week 11
Fatigue Severity Scale (FSS)
Time frame: Baseline, change in 4 weeks
Number Who Completed Medication as Randomized
Time frame: week 4
Number of Participants With Drug Safety Reports
Time frame: Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Parkinson's Disease
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanya Simuni, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amantadine in people with Parkinson's Disease, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go (TUG) - ON Usual Medication (time frame: Baseline, change at 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2019.