Efficacy and Safety of Amantadine HCl Extended Release Tablets to Treat Parkinson's Disease Patients With Levodopa Induced Dyskinesia.
Information source: Osmotica Pharmaceutical Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Parkinson's Disease; Levodopa Induced Dyskinesias (LID)
Intervention: Amantadine ER Tablets (Drug); Placebo Tablets for Amantadine ER Tablets (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Osmotica Pharmaceutical Corp. Official(s) and/or principal investigator(s): Gene Wright, PharmD, PhD, Study Chair, Affiliation: Osmotica Pharmaceutical Corp.
Overall contact: Gene Wright, PharmD, PhD, Phone: 770-509-5945, Email: clinicaltrials@osmotica.com
Summary
Amantadine has been used for many years as a treatment for Parkinson's disease. It has been
reported in the literature to effectively treat the motor complications of levodopa,
especially dyskinesia, but it must be given 2 to 4 times a day. 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. The dose will be given once a day in the morning so that amantadine concentrations
are maintained throughout the day for treating the levodopa induced dyskinesia, but will be
lower during the night, potentially reducing the negative impact of amantadine on sleep.
Clinical Details
Official title: A Multicenter, Randomized, Placebo-controlled, Double-blind, 16 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesias
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Unified Dyskinesia Rating Scale (UDysRS)
Secondary outcome: Unified Dyskinesia Rating Scale (UDysRS)Mobility State Self-Assessment (Subject Diary Cards) Mobility State Self-Assessment (Subject Diary Cards) MDS-UPDRS Fatigue Severity Scale
Eligibility
Minimum age: 30 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Signed IRB/IEC informed consent form.,
- Idiopathic Parkinson's disease per the 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.
Exclusion Criteria:
- 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.
- Pregnant or breastfeeding at screening or has a positive pregnancy test
- If a sexually active female, is not surgically sterile or at least 2 years
post-menopausal, or does not agree to utilize an effective method of contraception
from the screening visit to at least 4 weeks after the completion of study treatment.
- History of alcohol or narcotic substance abuse ≤1 year before screening.
- Has dementia or another psychiatric illness that prevents provision of informed
consent.
- Has a known hypersensitivity to the study treatment(s), based on known allergies to
drugs of the same class including rimantadine HCl and memantine HCl.
- Has participated in other studies involving investigational drugs or surgeries within
the last 30 days or investigational biologics within the last 6 months prior to
screening.
- Plans to undergo major elective surgery during the course of the study.
- Received administration of Live Attenuated Influenza Vaccine (LAIV) within 2 weeks.
- Cognitive impairment, as evidenced by a score <26 on the Montreal Cognitive
Assessment (MoCA) at the screening visit.
Locations and Contacts
Gene Wright, PharmD, PhD, Phone: 770-509-5945, Email: clinicaltrials@osmotica.com
Amiens, France; Recruiting
Bordeaux, France; Recruiting
Clermont-Ferrand, France; Recruiting
Creteil, France; Recruiting
Lille, France; Recruiting
Montauban, France; Recruiting
Nimes, France; Recruiting
Paris, France; Recruiting
Poitiers, France; Recruiting
Toulouse, France; Recruiting
Berlin, Germany; Recruiting
Barcelona, Spain; Recruiting
Gilbert, Arizona, United States; Recruiting
Tucson, Arizona, United States; Recruiting
Cataluña, Barcelona, Spain; Recruiting
Llobregat, Barcelona, Spain; Recruiting
Manresa, Barcelona, Spain; Recruiting
Marañón, Barcelona, Spain; Recruiting
Sevilla, Barcelona, Spain; Recruiting
Villaroel, Barcelona, Spain; Recruiting
Haag, Bayern, Germany; Recruiting
Muenchen, Bayern, Germany; Recruiting
Hindenburgdamm, Berlin, Germany; Recruiting
Weissensee, Berlin, Germany; Recruiting
Fresno, California, United States; Recruiting
Irvine, California, United States; Recruiting
San Diego, California, United States; Recruiting
Whittier, California, United States; Recruiting
Boulder, Colorado, United States; Recruiting
Danbury, Connecticut, United States; Recruiting
Boca Raton, Florida, United States; Recruiting
Port Charlotte, Florida, United States; Recruiting
Tampa, Florida, United States; Recruiting
Atlanta, Georgia, United States; Recruiting
Erbach, Hessen, Germany; Recruiting
Chicago, Illinois 60612, United States; Recruiting
Elk Grove Village, Illinois, United States; Recruiting
Indianapolis, Indiana, United States; Recruiting
Hammond, Louisiana, United States; Recruiting
Alcorcón, Madrid, Spain; Recruiting
Castellana, Madrid, Spain; Recruiting
Traverse City, Michigan, United States; Recruiting
Kingston, New Jersey, United States; Recruiting
Lawrence Township, New Jersey, United States; Recruiting
Amherst, New York, United States; Recruiting
Achim, Niedersachsen, Germany; Recruiting
Bochum, Nordrhein-Westfalen, Germany; Recruiting
Asheville, North Carolina, United States; Recruiting
Columbus, Ohio, United States; Recruiting
Ottawa, Ontario, Canada; Recruiting
Allentown, Pennsylvania, United States; Recruiting
Virginia Beach, Virginia, United States; Recruiting
Additional Information
Starting date: June 2014
Last updated: May 14, 2015
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