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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

Page last updated: August 23, 2015

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