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Parkinson's DiseasePhase 3ALLAY-LID-INCT02153645

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

A Phase 3 study testing 240mg Amantadine HCl ER tablets and 320mg Amantadine HCl ER tablets in people with Parkinson's Disease and Levodopa Induced Dyskinesias (LID), run by Adamas Pharmaceuticals, Inc. at 56 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 30 to 85 years
What is being tested?
240mg Amantadine HCl ER tablets and 320mg Amantadine HCl ER tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
87 participants
Where
56 sitesin 5 countries
Study dates
18 Aug 2014to 20 May 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 24Show fewer
  • 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.

Trial locations and contacts

56 sites in 5 countries.

56 sites in 5 countries

United States26 sites

  • Study site

    Ann Arbor, Michigan, 48103

  • Study site

    Ann Arbor, Michigan, 48109

  • Study site

    Baton Rouge, Louisiana, 70810

  • Study site

    Boulder, Colorado, 80304

  • Study site

    Brooklyn, New York, 11203

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Columbus, Ohio, 43221

  • Study site

    Fountain Valley, California, 92708

  • Study site

    Hollywood, Florida, 33021

  • Study site

    Indianapolis, Indiana, 46202

  • Study site

    Irvine, California, 92697

  • Study site

    Kirkland, Washington, 98034

  • Study site

    Manhasset, New York, 11020

  • Study site

    Miami, Florida, 33101

  • Study site

    North Palm Beach, Florida, 33403

  • Study site

    Orem, Utah, 84058

  • Study site

    Pasadena, California, 91105

  • Study site

    Patchogue, New York, 11772

  • Study site

    Raleigh, North Carolina, 27612

  • Study site

    Reseda, California, 91335

  • Study site

    Round Rock, Texas, 78681

  • Study site

    Summit, New Jersey, 07901

  • Study site

    Tampa, Florida, 33612

  • Study site

    Tucson, Arizona, 85724

  • Study site

    Ventura, California, 93001

  • Study site

    Ventura, California, 93003

Other trials in United States

France12 sites

  • Study site

    Amiens

  • Study site

    Bron, 69677

  • Study site

    Clermont-Ferrand

  • Study site

    Créteil

  • Study site

    Lille

  • Study site

    Marseille, 13385

  • Study site

    Montauban

  • Study site

    Nîmes

  • Study site

    Paris

  • Study site

    Poitiers

  • Study site

    Rennes, Ille-et-Vilaine

  • Study site

    Toulouse

Other trials in France

Germany8 sites

  • Study site

    Achim, Lower Saxony

  • Study site

    Berlin, 13088

  • Study site

    Berlin

  • Study site

    Bochum, North Rhine-Westphalia

  • Study site

    Erbach im Odenwald, Hesse

  • Study site

    Haag, Bavaria

  • Study site

    Weissensee, State of Berlin

  • Study site

    Würzburg, 97080

Other trials in Germany

Spain8 sites

  • Study site

    Alcorcón, Madrid

  • Study site

    Barcelona, 08036

  • Study site

    Barcelona, 08041

  • Study site

    Barcelona

  • Study site

    Castellana, Madrid

  • Study site

    Manresa, Barcelona

  • Study site

    Pamplona, 31008

  • Study site

    Seville, Barcelona

Other trials in Spain

Canada2 sites

  • Study site

    London, Ontario

  • Study site

    Ottawa, Ontario

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
240mg Amantadine HCl ER tablets, Placebo tablets, 320mg Amantadine HCl ER tablets
Keywords
Parkinson's Disease, Levodopa Induced Dyskinesias (LID), Dyskinesias, Parkinsonism
Medical subject headings
Parkinson Disease, Dyskinesias, Parkinsonian Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 240mg Amantadine HCl ER tabletsDrug

    Also called Osmolex ER 240 mg Tablet

  • Placebo tabletsDrug

  • 320mg Amantadine HCl ER tabletsDrug

    Also called Osmolex ER 320mg Tablet

Study groups in NCT02153645
Study groupRoleWhat they receive
240mg Amantadine HCl ER tabletsExperimentalAmantadine HCl ER Tablets 240mg daily for 12 weeks post two week titration phase.
Receives: Drug: 240mg Amantadine HCl ER tablets
320mg Amantadine HCl ER tabletsExperimentalAmantadine HCl ER Tablets 320mg daily for 12 weeks post a two week dose titration phase.
Receives: Drug: 320mg Amantadine HCl ER tablets
Placebo tabletsPlacebo comparatorPlacebo Tablets matching Amantadine HCl ER Tablets taken daily for 16 weeks.
Receives: Drug: Placebo tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Unified Dyskinesia Rating Scale

    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).

    Measured: From baseline to Day 98

Secondary outcomes (1)

  1. Mobility State Self-Assessment - Subject Diary Cards

    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.

    Measured: Day 14 and Day 98 of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2014 (estimated)
  2. Study start18 Aug 2014
  3. Primary completion20 May 2016
  4. Study completion20 May 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02153645
Sponsor's protocol ID
OS320-3005
Acronym
ALLAY-LID-I
Status last verified
Feb 2022
First submitted
30 May 2014
Last updated
16 Feb 2022
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 240mg Amantadine HCl ER tablets and 320mg Amantadine HCl ER tablets in people with Parkinson's Disease and Levodopa Induced Dyskinesias (LID), run by Adamas Pharmaceuticals, Inc. at 56 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in United States, France, Germany, Spain, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Unified Dyskinesia Rating Scale (time frame: From baseline to Day 98). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02153645.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.

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