Efficacy and Safety of Amantadine Hydrogen Chloride (HCl) ER Tablets in Parkinson's Disease Subjects With LID

• Register: ClinicalTrials.gov
• Last refreshed on: 28 February 2022
• Main ID: NCT02153632
• Date of registration: 30/05/2014
• Prospective Registration: Yes
• Primary sponsor: Adamas Pharmaceuticals, Inc.
• 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
• 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

Parkinson's Disease

Levodopa Induced Dyskinesia (LID)

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

Results

• Results available: Yes
• Date Posted: 02/04/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02153632