Efficacy and Safety of Amantadine Hydrochloride (HCl) ER Tablets to Treat Parkinson's Disease Patients With LID.

NCT02153645 | Terminated Phase 3 Results

• 1 other identifier: OS320-3005
• Study Type: interventional
• Target: 87
• Locations: 5 countries
• Sites: 56

Brief Summary

This study was terminated early due to slow enrollment with 87 of 162 planned subjects enrolled. The purpose of this multi-center, randomized, double-blind, parallel-group, 16 week study is to compare the efficacy and safety of two different dose levels of Amantadine Extended Release Tablets to placebo for the treatment of levodopa induced dyskinesia in patients with Parkinson's disease.

Conditions

Parkinson's Disease; Levodopa Induced Dyskinesias (LID)

Keywords

Parkinson's Disease; Levodopa Induced Dyskinesias (LID); Dyskinesias; Parkinsonism

Outcome Measures

Primary Outcomes (1)

• Unified Dyskinesia Rating Scale

  The Unified Dyskinesia Rating Scale is a validated tool for assessment of dyskinesia (involuntary movements) in Parkinson's Disease patients. Rating consists of the change from baseline to Day 98 of the sum of the 26 questions comprising the questionnaire. Each question in the questionnaire is rated on a 5 point scale from 0-4 where 0 is a better outcome. Questions assess: over the past week total hours with dyskinesia and total hours without dyskinesia; problems with speech, chewing and swallowing, eating, dressing, hygiene, handwriting, hobbies, balance, socializing, emotions, spasm or cramps, pain without dystonia (spasm or cramps) and pain from dystonia, the degree of impairment for each of 7 body parts, and the degree of disability in communication, drinking from a cup, dressing and ambulation. The minimum score is 0 (better) and the maximum score is 130 (worse).

  From baseline to Day 98

Secondary Outcomes (1)

• Mobility State Self-Assessment - Subject Diary Cards

  Day 14 and Day 98 of treatment

Study Arms (3)

240mg Amantadine HCl ER tablets

EXPERIMENTAL

Amantadine HCl ER Tablets 240mg daily for 12 weeks post two week titration phase.

Drug: 240mg Amantadine HCl ER tablets

320mg Amantadine HCl ER tablets

EXPERIMENTAL

Amantadine HCl ER Tablets 320mg daily for 12 weeks post a two week dose titration phase.

Drug: 320mg Amantadine HCl ER tablets

Placebo tablets

PLACEBO COMPARATOR

Placebo Tablets matching Amantadine HCl ER Tablets taken daily for 16 weeks.

Drug: Placebo tablets

Interventions

240mg Amantadine HCl ER tablets DRUG

Also known as: Osmolex ER 240 mg Tablet

240mg Amantadine HCl ER tablets

Placebo tablets DRUG

Placebo tablets

320mg Amantadine HCl ER tablets DRUG

Also known as: Osmolex ER 320mg Tablet

320mg Amantadine HCl ER tablets

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Investigational Review Board/Independent Ethics Review Committee (IRB/IEC) informed consent form.,
• Idiopathic Parkinson's disease per the United Kingdom (UK) Parkinson's Disease Society Brain Bank criteria.
• Male or female 30 to 85 years old.
• Levodopa induced, predictable peak-effect dyskinesia considered problematic and/or disabling.
• Screening serum creatinine level within normal range
• On stable doses of all oral anti-Parkinson's medication, including any levodopa preparation, for 30 days and be willing to remain on the same doses throughout the trial.
• The subject/caregiver must demonstrate the ability to complete an accurate home diary based on training and evaluation during the screening period.

You may not qualify if:

• Secondary parkinsonian syndrome, such as vascular, postinflammatory,drug-induced, neoplastic and post-traumatic parkinsonism or any atypical parkinsonian syndrome (e.g., Progressive Supranuclear Palsy, Multi-System Atrophy, etc.);
• Use of amantadine within 14 days before study start, or previously had an adverse event to amantadine
• Currently taking neuroleptics and atypical antipsychotic agents, acetylcholinesterase inhibitors, apomorphine, rimantadine, memantine and dextromethorphan and quinidine if used in combination for treating dyskinesia.
• History of neurosurgical intervention for treating Parkinson's s disease (i.e. pallidotomy or implanted with a deep brain stimulator).
• Any medical condition or past medical history that would increase the risk of exposure to Amantadine HCl Extended Release Tablets or interfere with safety and efficacy evaluations.
• History of cancer within 5 years of screening with following exceptions: adequately treated non-melanomatous skin cancers, localized bladder cancer, non-metastatic prostate cancer or in situ cervical cancer.
• History or current diagnosis of schizophrenia or bipolar disorder;
• Inadequately treated Major Depressive Disorder. Subjects on stable doses of selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) are eligible for the study.
• Is at imminent risk of suicide or had a suicide attempt within 6 months of screening
• History or current diagnosis of Impulse Control Disorder
• Calculated plasma creatinine clearance of \<60 mL/min at screening
• History of or currently has any of the following clinically significant conditions, cardiovascular, respiratory, renal, hepatic, or gastrointestinal disease
• Any clinically significant vital sign, ECG, or laboratory abnormalities:
• A positive test for HIV antibody or history of HIV; hepatitis B surface antigen unless the positive test followed a recent (\<28 days) vaccination for hepatitis B; hepatitis C antibody.
• A positive urine drug test.

Sponsors & Collaborators

• Adamas Pharmaceuticals, Inc.: lead

Study Sites (56)

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Tucson, Arizona, 85724, United States

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Fountain Valley, California, 92708, United States

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Irvine, California, 92697, United States

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Pasadena, California, 91105, United States

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Reseda, California, 91335, United States

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Ventura, California, 93001, United States

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Ventura, California, 93003, United States

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Boulder, Colorado, 80304, United States

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Hollywood, Florida, 33021, United States

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Miami, Florida, 33101, United States

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North Palm Beach, Florida, 33403, United States

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Tampa, Florida, 33612, United States

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Chicago, Illinois, 60612, United States

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Indianapolis, Indiana, 46202, United States

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Baton Rouge, Louisiana, 70810, United States

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Ann Arbor, Michigan, 48103, United States

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Ann Arbor, Michigan, 48109, United States

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Summit, New Jersey, 07901, United States

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Brooklyn, New York, 11203, United States

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Manhasset, New York, 11020, United States

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Patchogue, New York, 11772, United States

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Raleigh, North Carolina, 27612, United States

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Columbus, Ohio, 43221, United States

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Round Rock, Texas, 78681, United States

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Orem, Utah, 84058, United States

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Kirkland, Washington, 98034, United States

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London, Ontario, Canada

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Ottawa, Ontario, Canada

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Rennes, Ille-et-Vilaine, France

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Amiens, France

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Bron, 69677, France

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Clermont-Ferrand, France

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Créteil, France

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Lille, France

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Marseille, 13385, France

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Montauban, France

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Nîmes, France

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Paris, France

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Poitiers, France

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Toulouse, France

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Haag, Bavaria, Germany

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Erbach im Odenwald, Hesse, Germany

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Achim, Lower Saxony, Germany

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Bochum, North Rhine-Westphalia, Germany

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Weissensee, State of Berlin, Germany

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Berlin, 13088, Germany

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Berlin, Germany

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Würzburg, 97080, Germany

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Manresa, Barcelona, Spain

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Seville, Barcelona, Spain

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Alcorcón, Madrid, Spain

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Castellana, Madrid, Spain

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Barcelona, 08036, Spain

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Barcelona, 08041, Spain

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Barcelona, Spain

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Pamplona, 31008, Spain

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MeSH Terms

Conditions

Parkinson Disease; Dyskinesias; Parkinsonian Disorders

Interventions

Amantadine; Tablets

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: George Wagner, VP of Regulatory Affairs
• Organization: Osmotica Pharmaceuticals

gwagner@osmotica.ccom

908-809-1357

Study Officials

• Angela Dentiste, MBA

  Osmotica Pharmaceutical US LLC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2014
• First Posted: June 3, 2014
• Study Start: August 18, 2014
• Primary Completion: May 20, 2016
• Study Completion: May 20, 2016
• Last Updated: February 16, 2022
• Results First Posted: April 2, 2019

Record last verified: 2022-02

Locations

FR (12); US (26); ES (8); DE (8); CA (2)