World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02153632
Date of registration: 30/05/2014
Prospective Registration: Yes
Primary sponsor: Osmotica Pharmaceutical US LLC
Public title: Efficacy and Safety of Amantadine Hydrogen Chloride (HCl) ER Tablets in Parkinson's Disease Subjects With LID ALLAY-LID-II
Scientific title: A Multicenter, Randomized, Placebo-controlled, Double-blind, 26 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesias
Date of first enrolment: July 30, 2014
Target sample size: 135
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT02153632
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 3
Countries of recruitment
Canada France Germany Spain United States
Contacts
Name:     Angela Dentiste, MBA
Address: 
Telephone:
Email:
Affiliation:  Osmotica Pharmaceutical US LLC
Key inclusion & exclusion criteria

Inclusion Criteria:

- Signed Institutional Review Board (IRB)/ Independent Ethics Committee (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.



Age minimum: 30 Years
Age maximum: 85 Years
Gender: All
Health Condition(s) or Problem(s) studied
Levodopa Induced Dyskinesia (LID)
Parkinson's Disease
Intervention(s)
Drug: amantadine HCl ER
Drug: Placebo
Primary Outcome(s)
Unified Dyskinesia Rating Scale [Time Frame: Change from baseline to Day 98]
Secondary Outcome(s)
Mobility State Self-Assessment - Subject Diary Cards [Time Frame: Day 14 and Day 98 of treatment]
Secondary ID(s)
OS320-3006
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 02/04/2019
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02153632
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history