Clinical trial NCT01652534: Efficacy Study of Amantadine to Treat Gait Dysfunction and Freezing in Parkinson's Disease
Official title: Efficacy of Amantadine for Gait Dysfunction and Gait Freezing in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Parkinson's Disease
Keywords: Freezing of gait
gait dysfunction
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2012-07-30
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Eligibility 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

Primary outcomes:
measure: Timed Up and Go (TUG) - ON Usual Medication
timeFrame: Baseline, change at 4 weeks
measure: Timed Up and Go (TUG) - OFF Usual Medication
timeFrame: Baseline, change at 4 weeks
Secondary outcomes:
measure: Modified Timed Up and Go (mTUG)
timeFrame: Baseline, change in 4 weeks
measure: Analysis of Motor Functioning Using the Parkinson's Home Diaries
timeFrame: Baseline, change in 4 weeks
measure: Freezing of Gait Questionnaire
timeFrame: Baseline, change in 4 weeks
measure: Clinical Global Impression (CGI)
timeFrame: 4 weeks
measure: Parkinson's Disease Questionnaire-39 (PDQ-39)
timeFrame: Baseline, week 4
measure: Gait Analysis Testing
timeFrame: Baseline, week 4, week 7, week 11
measure: Fatigue Severity Scale (FSS)
timeFrame: Baseline, change in 4 weeks
measure: Number Who Completed Medication as Randomized
timeFrame: week 4
measure: Number of Participants With Drug Safety Reports
timeFrame: Week 4
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Tanya Simuni, MD
role: PRINCIPAL_INVESTIGATOR
References: