Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02153645
Recruitment Status : Terminated
First Posted : June 3, 2014
Results First Posted : April 2, 2019
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Osmotica Pharmaceutical US LLC

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Levodopa Induced Dyskinesias (LID) Drug: 240mg Amantadine HCl ER tablets Drug: Placebo tablets Drug: 320mg Amantadine HCl ER tablets Phase 3

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 18, 2014
Actual Primary Completion Date : May 20, 2016
Actual Study Completion Date : May 20, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 240mg Amantadine HCl ER tablets
Amantadine HCl ER Tablets 240mg daily for 12 weeks post two week titration phase.
Drug: 240mg Amantadine HCl ER tablets
Other Name: Osmolex ER 240 mg Tablet

Experimental: 320mg Amantadine HCl ER tablets
Amantadine HCl ER Tablets 320mg daily for 12 weeks post a two week dose titration phase.
Drug: 320mg Amantadine HCl ER tablets
Other Name: Osmolex ER 320mg Tablet

Placebo Comparator: Placebo tablets
Placebo Tablets matching Amantadine HCl ER Tablets taken daily for 16 weeks.
Drug: Placebo tablets



Primary Outcome Measures :
  1. Unified Dyskinesia Rating Scale [ Time Frame: From baseline to Day 98 ]
    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).


Secondary Outcome Measures :
  1. Mobility State Self-Assessment - Subject Diary Cards [ Time Frame: Day 14 and Day 98 of treatment ]
    Change from baseline in the number of awake hours without troublesome dyskinesia (involuntary movements). Every half hour the subject will indicate in the diary if the medication has ("ON") or has not ("OFF") produced benefits in terms of mobility, slowness and rigidity. Valid diaries of the 3 consecutive days prior to each visit will be averaged with respect to the number of awake hours without troublesome dyskinesia. The change from baseline in the number of waking hours that subjects report being "ON" without troublesome dyskinesias will be analyzed at analysis visits Day 14 and Day 98 of treatment. Higher scores mean a better outcome and the maximum value is 24 hours.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153645


  Show 56 Study Locations
Sponsors and Collaborators
Osmotica Pharmaceutical US LLC
Investigators
Layout table for investigator information
Study Chair: Angela Dentiste, MBA Osmotica Pharmaceutical US LLC

Layout table for additonal information
Responsible Party: Osmotica Pharmaceutical US LLC
ClinicalTrials.gov Identifier: NCT02153645     History of Changes
Other Study ID Numbers: OS320-3005
First Posted: June 3, 2014    Key Record Dates
Results First Posted: April 2, 2019
Last Update Posted: April 12, 2019
Last Verified: April 2019
Keywords provided by Osmotica Pharmaceutical US LLC:
Parkinson's Disease
Levodopa Induced Dyskinesias (LID)
Dyskinesias
Parkinsonism
Additional relevant MeSH terms:
Layout table for MeSH terms
Amantadine
Parkinson Disease
Dyskinesias
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents