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

Last updated: February 14, 2022
Sponsor: Adamas Pharmaceuticals, Inc.
Overall Status: Terminated

Phase

3

Condition

Parkinson's Disease

Dyskinesias

Treatment

N/A

Clinical Study ID

NCT02153645
OS320-3005
  • Ages 30-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 SocietyBrain Bank criteria.
  • Male or female 30 to 85 years old.
  • Levodopa induced, predictable peak-effect dyskinesia considered problematic and/ordisabling.
  • Screening serum creatinine level within normal range
  • On stable doses of all oral anti-Parkinson's medication, including any levodopapreparation, for 30 days and be willing to remain on the same doses throughout thetrial.
  • The subject/caregiver must demonstrate the ability to complete an accurate home diarybased on training and evaluation during the screening period.

Exclusion

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 adverseevent to amantadine
  • Currently taking neuroleptics and atypical antipsychotic agents, acetylcholinesteraseinhibitors, apomorphine, rimantadine, memantine and dextromethorphan and quinidine ifused 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 exposureto Amantadine HCl Extended Release Tablets or interfere with safety and efficacyevaluations.
  • History of cancer within 5 years of screening with following exceptions: adequatelytreated non-melanomatous skin cancers, localized bladder cancer, non-metastaticprostate 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 selectiveserotonin 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 unlessthe positive test followed a recent (<28 days) vaccination for hepatitis B; hepatitisC 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 yearspost-menopausal, or does not agree to utilize an effective method of contraceptionfrom 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 informedconsent.
  • Has a known hypersensitivity to the study treatment(s), based on known allergies todrugs of the same class including rimantadine HCl and memantine HCl.
  • Has participated in other studies involving investigational drugs or surgeries withinthe last 30 days or investigational biologics within the last 6 months prior toscreening.
  • 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.

Study Design

Total Participants: 87
Study Start date:
August 18, 2014
Estimated Completion Date:
May 20, 2016

Study Description

This study was terminated early due to slow enrollment with 87 of 162 planned subjects enrolled. 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.

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