Efficacy Study of Amantadine to Treat Gait Dysfunction and Freezing in Parkinson's Disease

Northwestern University

Status and phase: Terminated; Phase 3

Conditions: Parkinson's Disease

Treatments: Drug: Placebo; Drug: Amantadine

Study type: Interventional

Funder types: Other

Identifiers

NCT01652534

M012010

Details and patient eligibility

About

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.

Full description

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

Enrollment: 3 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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3 participants in 2 patient groups, including a placebo group

Amantadine

Active Comparator group

Description:

Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day

Treatment:

Drug: Amantadine

placebo

Placebo Comparator group

Description:

Sugar Pill

Treatment:

Drug: Placebo