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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02202551
First Posted: July 29, 2014
Last Update Posted: October 10, 2017
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.
Information provided by (Responsible Party):
Adamas Pharmaceuticals, Inc.
  Purpose
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 Intervention Phase
Dyskinesia Levodopa Induced Dyskinesia (LID) Parkinson's Disease (PD) Drug: ADS-5102 Phase 3

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Adamas Pharmaceuticals, Inc.:

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

Estimated Enrollment: 250
Study Start Date: July 2014
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ADS-5102
amantadine HCl extended release
Drug: ADS-5102
Other Name: amantadine HCl extended release

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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): NCT02202551


  Show 87 Study Locations
Sponsors and Collaborators
Adamas Pharmaceuticals, Inc.
Investigators
Study Director: Clinical Trials Director Adamas Pharmaceuticals, Inc.
  More Information

Responsible Party: Adamas Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02202551     History of Changes
Other Study ID Numbers: ADS-AMT-PD302
First Submitted: July 25, 2014
First Posted: July 29, 2014
Last Update Posted: October 10, 2017
Last Verified: October 2017

Keywords provided by Adamas Pharmaceuticals, Inc.:
Levodopa Induced Dyskinesia
LID
Parkinsonism
Parkinson's Disease

Additional relevant MeSH terms:
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
Amantadine
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