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Open-Label Safety Study of ADS-5102 in PD Patients With LID

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. Identifier: NCT02202551
Recruitment Status : Unknown
Verified October 2017 by Adamas Pharmaceuticals, Inc..
Recruitment status was:  Active, not recruiting
First Posted : July 29, 2014
Last Update Posted : October 10, 2017
Information provided by (Responsible Party):
Adamas Pharmaceuticals, Inc.

Brief Summary:
This is a 105-week open-label study to evaluate the safety and tolerability of ADS-5102 oral capsules, an extended release formulation of amantadine, in Parkinson's Disease (PD) patients with Levodopa Induced Dyskinesia (LID).

Condition or disease Intervention/treatment Phase
Dyskinesia Levodopa Induced Dyskinesia (LID) Parkinson's Disease (PD) Drug: ADS-5102 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia (LID)
Study Start Date : July 2014
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ADS-5102
amantadine HCl extended release
Drug: ADS-5102
Other Name: amantadine HCl extended release

Primary Outcome Measures :
  1. Safety and tolerability of ADS-5102 assessed by adverse events, safety-related study drug discontinuation, vital signs, and safety laboratory tests [ Time Frame: Up to 105 weeks ]

Secondary Outcome Measures :
  1. Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [ Time Frame: Up to 105 weeks ]

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.

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

Inclusion Criteria:

  • Signed a current IRB/REB/IEC-approved informed consent form
  • Completed all study visits in previous Adamas efficacy study or were ineligible for participation in previous Adamas studies due to having undergone prior deep brain stimulation.
  • Parkinson's disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria
  • On a stable regimen of antiparkinson's medications at least 30 days prior to screening, including a levodopa preparation administered not less than three times daily.
  • History of peak dose dyskinesia that might benefit from specific dyskinesia treatment in the judgment of the subject and clinical investigator

Exclusion Criteria:

  • Discontinued ADS-5102 in previous Adamas efficacy study due to intolerable or unacceptable AEs considered to be related to ADS-5102
  • History of neurosurgical intervention related to Parkinson's disease, with the exception of deep brain stimulation
  • History of seizures since completion of participation in previous Adamas studies or within 2 years
  • History of stroke or TIA since completion of participation in previous Adamas studies or within 2 years
  • History of cancer since completion of participation in previous Adamas studies or within 2 years, with the following exceptions: adequately treated non-melanomatous skin cancers, localized bladder cancer, non-metastatic prostate cancer or in situ cervical cancer
  • Presence of cognitive impairment, as evidenced by a Mini-Mental Status Examination (MMSE) score of less than 24 during screening
  • If female is pregnant or lactating
  • 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 screening through at least 4 weeks after the completion of study treatment.
  • Treatment with an investigational drug (other than ADS-5102) or device within 30 days prior to screening
  • Treatment with an investigational biologic within 6 months prior to screening
  • Current or planned participation in another interventional clinical trial

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 identifier (NCT number): NCT02202551

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Sponsors and Collaborators
Adamas Pharmaceuticals, Inc.
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Study Director: Clinical Trials Director Adamas Pharmaceuticals, Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Adamas Pharmaceuticals, Inc. Identifier: NCT02202551    
Other Study ID Numbers: ADS-AMT-PD302
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: October 2017
Keywords provided by Adamas Pharmaceuticals, Inc.:
Levodopa Induced Dyskinesia
Parkinson's Disease
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
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
Sensory System Agents
Peripheral Nervous System Agents