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

NCT01652534 | Terminated Phase 3 Results

• 1 other identifier: M012010
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

Freezing of gait; gait dysfunction

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, change at 4 weeks

Secondary Outcomes (9)

• Modified Timed Up and Go (mTUG)

  Baseline, change in 4 weeks

• Analysis of Motor Functioning Using the Parkinson's Home Diaries

  Baseline, change in 4 weeks

• Freezing of Gait Questionnaire

  Baseline, change in 4 weeks

• Clinical Global Impression (CGI)

  4 weeks

• Parkinson's Disease Questionnaire-39 (PDQ-39)

  Baseline, week 4

Study Arms (2)

Amantadine

ACTIVE COMPARATOR

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

Drug: Amantadine

placebo

PLACEBO COMPARATOR

Sugar Pill

Drug: Placebo

Interventions

Amantadine DRUG

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).

Also known as: Symmetrel

Amantadine

Placebo DRUG

Sugar Pill

Also known as: Sugar Pill

placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Amantadine; Sugars

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Carbohydrates

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Dr. Tanya Simuni
• Organization: Northwestern University

tsimuni@nm.org

312-503-2970

Study Officials

• Tanya Simuni, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology Director, Parkinson's Disease and Movement Disorders Center

Study Record Dates

• First Submitted: August 15, 2011
• First Posted: July 30, 2012
• Study Start: June 1, 2011
• Primary Completion: May 1, 2015
• Study Completion: August 1, 2015
• Last Updated: November 13, 2019
• Results First Posted: November 13, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)