Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)
This study is ongoing, but not recruiting participants.
Sponsor:
Adamas Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Adamas Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01397422
First received: July 18, 2011
Last updated: May 20, 2013
Last verified: May 2013
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Purpose
This is a multi-center, randomized, double-blind, placebo-controlled, 4-arm parallel group study to evaluate the tolerability and efficacy of each of three dose levels of ADS-5102 oral capsules, an extended release formulation of amantadine, dosed once daily for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel pharmacokinetic profile of ADS-5102 is expected to achieve i) higher amantadine plasma concentrations during daytime hours when dyskinesia as well as motor and non-motor symptoms of PD are most problematic, ii) low amantadine plasma concentrations overnight, which may reduce the sleep disturbances and vivid dreams occasionally associated with amantadine, and iii) a reduced initial rate of rise in plasma concentration, which is expected to improve overall tolerability of amantadine.
| Condition | Intervention | Phase |
|---|---|---|
|
Dyskinesia Levodopa Induced Dyskinesia Parkinson's Disease |
Drug: ADS-5102 (extended release amantadine HCl) |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study) |
Resource links provided by NLM:
Further study details as provided by Adamas Pharmaceuticals, Inc.:
Primary Outcome Measures:
- Change in the Unified Dyskinesia Rating Scale (UDysRS) total score [ Time Frame: Baseline (Day 1) to week 8 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Total Objective Score (III, IV) of the UDysRS [ Time Frame: Baseline (Day 1) to week 8 ] [ Designated as safety issue: No ]
- ON time without troublesome dyskinesia (ON without dyskinesia plus ON with non-troublesome dyskinesia), based on a standardized PD home diary [ Time Frame: Baseline (Day 1) to week 8 ] [ Designated as safety issue: No ]
- Unified Parkinson's Disease Rating Scale (MDS-UPDRS), individual and combined scores (Parts I, II, III) [ Time Frame: Baseline (Day 1) to week 8 ] [ Designated as safety issue: No ]
- Clinician's Global Impression of Change in overall PD symptoms [ Time Frame: Baseline (Day 1) to week 8 ] [ Designated as safety issue: No ]
- Fatigue Severity Score (FSS) [ Time Frame: Baseline (Day 1) to week 8 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | June 2013 |
| Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Treatment A |
Drug: ADS-5102 (extended release amantadine HCl)
Oral capsules to be administered once daily at bedtime, for 8 weeks
|
|
Active Comparator: Treatment B
Low dose ADS-5102 (amantadine extended release)
|
Drug: ADS-5102 (extended release amantadine HCl)
Oral capsules to be administered once daily at bedtime, for 8 weeks
|
|
Active Comparator: Treatment C
A mid-dose ADS-5102 (amantadine extended release)
|
Drug: ADS-5102 (extended release amantadine HCl)
Oral capsules to be administered once daily at bedtime, for 8 weeks
|
|
Active Comparator: Treatment D
High dose ADS-5102 (amantadine extended release)
|
Drug: ADS-5102 (extended release amantadine HCl)
Oral capsules to be administered once daily at bedtime, for 8 weeks
|
Eligibility| Ages Eligible for Study: | 30 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Signed a current IRB/IEC-approved informed consent form
- Parkinson's disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria
- On a stable regimen of antiparkinson's medications , including any levodopa preparation administered not less than three times daily, and willing to continue the same doses and regimens during study participation
- Experiencing troublesome dyskinesia following levodopa dosing (peak dose dyskinesia)
- Able to understand and complete a standardized PD home diary, following training
Exclusion Criteria:
- History of neurosurgical intervention related to Parkinson's disease (e.g. deep brain stimulation)
- History of seizures or stroke/TIA within 2 years of screening
- History of cancer within 5 years of screening, except adequately treated non-melanomatous skin cancers, localized bladder cancer, non-metastatic prostate cancer or in situ cervical cancer
- Estimated GFR < 50 mL/min/1.73m2
- 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, or has a positive pregnancy test result pre-dose
- 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 or device within 30 days prior to screening
- Treatment with an investigational biologic within 6 months prior to screening
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01397422
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Hide Study LocationsLocations
| United States, Arizona | |
| Sun City, Arizona, United States | |
| United States, California | |
| Fountain Valley, California, United States | |
| Long Beach, California, United States | |
| Los Angeles, California, United States | |
| Oxnard, California, United States | |
| Pasadena, California, United States | |
| Reseda, California, United States | |
| Sunnyvale, California, United States | |
| Ventura, California, United States | |
| United States, Connecticut | |
| Fairfield, Connecticut, United States | |
| United States, Florida | |
| Boca Raton, Florida, United States | |
| Bradenton, Florida, United States | |
| Port Charlotte, Florida, United States | |
| Tampa, Florida, United States | |
| United States, Georgia | |
| Atlanta, Georgia, United States | |
| Augusta, Georgia, United States | |
| United States, Illinois | |
| Chicago, Illinois, United States | |
| Winfield, Illinois, United States | |
| United States, Iowa | |
| Des Moines, Iowa, United States | |
| United States, Kansas | |
| Kansas City, Kansas, United States | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States | |
| United States, Michigan | |
| West Bloomfield, Michigan, United States | |
| United States, New Jersey | |
| Toms River, New Jersey, United States | |
| United States, New York | |
| New York, New York, United States | |
| United States, North Carolina | |
| Durham, North Carolina, United States | |
| Raleigh, North Carolina, United States | |
| United States, Ohio | |
| Toledo, Ohio, United States | |
| United States, Oklahoma | |
| Tulsa, Oklahoma, United States | |
| United States, Texas | |
| Houston, Texas, United States | |
| San Antonio, Texas, United States | |
| United States, Virginia | |
| Richmond, Virginia, United States | |
| United States, Washington | |
| Kirkland, Washington, United States | |
| United States, Wisconsin | |
| Milwaukee, Wisconsin, United States | |
Sponsors and Collaborators
Adamas Pharmaceuticals, Inc.
Investigators
| Study Director: | Clinical Trials Director | Adamas Pharmaceuticals, Inc. |
More Information
No publications provided
| Responsible Party: | Adamas Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01397422 History of Changes |
| Other Study ID Numbers: | ADS-PAR-AM201 |
| Study First Received: | July 18, 2011 |
| Last Updated: | May 20, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Adamas Pharmaceuticals, Inc.:
|
Levodopa-induced dyskinesia Parkinsonism |
Additional relevant MeSH terms:
|
Dyskinesias Parkinson Disease Movement Disorders Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Neurodegenerative Diseases Amantadine Levodopa Antiparkinson Agents |
Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Antiviral Agents Anti-Infective Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on June 18, 2013