Efficacy Study of Amantadine to Treat Gait Dysfunction and Freezing in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Amantadine; Placebo
Intervention description: 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).; Sugar Pill
Intervention MeSH terms: Amantadine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Freezing of gait; gait dysfunction

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.
    

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