Efficacy and Safety of Amantadine Hydrochloride (HCl) ER Tablets to Treat Parkinson's Disease Patients With LID. (ALLAY-LID-I)
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|ClinicalTrials.gov Identifier: NCT02153645|
Recruitment Status : Terminated
First Posted : June 3, 2014
Results First Posted : April 2, 2019
Last Update Posted : April 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease Levodopa Induced Dyskinesias (LID)||Drug: 240mg Amantadine HCl ER tablets Drug: Placebo tablets Drug: 320mg Amantadine HCl ER tablets||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||87 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||August 18, 2014|
|Actual Primary Completion Date :||May 20, 2016|
|Actual Study Completion Date :||May 20, 2016|
Experimental: 240mg Amantadine HCl ER tablets
Amantadine HCl ER Tablets 240mg daily for 12 weeks post two week titration phase.
Drug: 240mg Amantadine HCl ER tablets
Other Name: Osmolex ER 240 mg Tablet
Experimental: 320mg Amantadine HCl ER tablets
Amantadine HCl ER Tablets 320mg daily for 12 weeks post a two week dose titration phase.
Drug: 320mg Amantadine HCl ER tablets
Other Name: Osmolex ER 320mg Tablet
Placebo Comparator: Placebo tablets
Placebo Tablets matching Amantadine HCl ER Tablets taken daily for 16 weeks.
Drug: Placebo tablets
- Unified Dyskinesia Rating Scale [ Time Frame: From baseline to Day 98 ]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).
- Mobility State Self-Assessment - Subject Diary Cards [ Time Frame: Day 14 and Day 98 of treatment ]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.
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): NCT02153645
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|Study Chair:||Angela Dentiste, MBA||Osmotica Pharmaceutical US LLC|