Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Participation in this study was offered to subjects who were described by one of the following 3 groups:
Consented subjects who completed Screening (Visit 1) and met study eligibility criteria were to have a Baseline Visit and receive study drug. During Week 1, subjects took 170 mg of ADS-5102 (1 capsule) daily at bedtime. For Week 2, the dose was increased to 340 mg (2 capsules) daily at bedtime; this dose was to continue through Week 100. During the final week (Week 101) of the study, the ADS-5102 dose was reduced to 170 mg (1 capsule) daily at bedtime. Subjects were enrolled into the study at Visit 2 (Baseline/Week 0) and were to return to the clinic after 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 weeks of study drug dosing. Subjects were to receive a telephone reminder at the end of Week 1 to increase their dose during Week 2. At the Week 100 Visit, subjects were instructed to reduce their dose to 1 capsule daily at bedtime for 1 week. The amount of available, unused drug was assessed during the Week 100 Visit; subjects were given an additional bottle of study drug, if needed, to complete the 1 week of reduced dosing.
Efficacy, as measured with the MDS-UPDRS, was to be evaluated at all study visits, beginning with the Screening Visit, and excluding the Baseline and Week 4 Visits. A Safety Follow-up Visit was to occur approximately 2 weeks following the completion of treatment. AEs were recorded beginning with the first dose of study drug and continued through the Safety Follow-up Visit. Concomitant medications were recorded throughout the study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADS-5102 | Experimental | amantadine HCl extended release |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADS-5102 | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | The primary objective of the study was to evaluate the safety and tolerability of ADS-5102 oral capsules, an extended release (ER) formulation of amantadine, administered at a dose of 340 mg once daily at bedtime for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). | Up to 101 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | To evaluate clinical progression of PD as assessed by the MDS-UPDRS, combined score, Parts I, II, and III. Part I - non-motor experiences of daily living; Part II - motor experiences of daily living; Part III - motor examination. Parts I and II each contain 13 questions measured on a 5-point scale (0-4). Part III contains 18 objective rater assessments of the motor signs of PD measured on a 5-point scale (0-4). Total range for combined score (Part I-III) is = 0-176. Generally for MDS-UPDRS scores and sub-scores, the lower the score, the better. Parts I, II, and III are summed to make the total score. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials Director | Adamas Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35233 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3280212 | Background | Aoki FY, Sitar DS. Clinical pharmacokinetics of amantadine hydrochloride. Clin Pharmacokinet. 1988 Jan;14(1):35-51. doi: 10.2165/00003088-198814010-00003. | |
| 20310033 | Background | Colosimo C, Martinez-Martin P, Fabbrini G, Hauser RA, Merello M, Miyasaki J, Poewe W, Sampaio C, Rascol O, Stebbins GT, Schrag A, Goetz CG. Task force report on scales to assess dyskinesia in Parkinson's disease: critique and recommendations. Mov Disord. 2010 Jul 15;25(9):1131-42. doi: 10.1002/mds.23072. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group 1a | Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1A received ADS-5102 in the prior study. |
| FG001 | Group 1P | Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1P received placebo in the prior study |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 16, 2015 | Jul 8, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to 101 weeks. MDS-UPDRS was performed at the following visits: Screening, Week 8, Week 16, Week 28, Week 40, Week 52, Week 64, Week 76, Week 88, Week 100 (or ET). |
| Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | This component (Questions 4.1 - 4.6) includes time spent with dyskinesia, functional impact of dyskinesia, time spent in OFF state, functional impact of fluctuations, complexity of motor fluctuations, painful OFF-state dystonia. Questions 4.1-4.6 are summed to make the Part IV score. Generally for MDS-UPDRS scores and sub-scores, the lower the score, the better. Total range for Part IV is = 0-24 | 100 Weeks. MDS-UPDRS was performed at the following visits: Screening, Week 8, Week 16, Week 28, Week 40, Week 52, Week 64, Week 76, Week 88, Week 100 (or ET). |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Scottsdale | Arizona | 85259 | United States |
| Sun City | Arizona | 85351 | United States |
| Fountain Valley | California | 92708 | United States |
| Pasadena | California | 91105 | United States |
| Reseda | California | 91335 | United States |
| Sacramento | California | 95817 | United States |
| Sunnyvale | California | 94085 | United States |
| Torrance | California | 90505 | United States |
| Ventura | California | 93003 | United States |
| Aurora | Colorado | 80045 | United States |
| Manchester | Connecticut | 06040 | United States |
| Boca Raton | Florida | 33486 | United States |
| Gainesville | Florida | 32607 | United States |
| Jacksonville | Florida | 32209 | United States |
| Naples | Florida | 34102 | United States |
| Port Charlotte | Florida | 33980 | United States |
| Sunrise | Florida | 33351 | United States |
| Tampa | Florida | 33612 | United States |
| Tampa | Florida | 33613 | United States |
| Weston | Florida | 33331 | United States |
| Atlanta | Georgia | 30329 | United States |
| Chicago | Illinois | 60611 | United States |
| Chicago | Illinois | 60612 | United States |
| Des Moines | Iowa | 45219 | United States |
| Kansas City | Kansas | 66160 | United States |
| Baltimore | Maryland | 21287 | United States |
| Elkridge | Maryland | 21075 | United States |
| Boston | Massachusetts | 02114 | United States |
| Bingham Farms | Michigan | 48025 | United States |
| West Bloomfield | Michigan | 48322 | United States |
| Golden Valley | Minnesota | 55427 | United States |
| St Louis | Missouri | 63110 | United States |
| Albany | New York | 12208 | United States |
| Commack | New York | 11725 | United States |
| New York | New York | 10003 | United States |
| New York | New York | 10016 | United States |
| New York | New York | 10029 | United States |
| Greensboro | North Carolina | 27405 | United States |
| Raleigh | North Carolina | 27607 | United States |
| Cincinnati | Ohio | 45219 | United States |
| Cleveland | Ohio | 44195 | United States |
| Toledo | Ohio | 43614 | United States |
| Tulsa | Oklahoma | 74136 | United States |
| Hershey | Pennsylvania | 17033 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Dallas | Texas | 75390 | United States |
| Houston | Texas | 77030-1 | United States |
| Houston | Texas | 77030-2 | United States |
| Roanoke | Virginia | 24018 | United States |
| Kirkland | Washington | 98034 | United States |
| Morgantown | West Virginia | 26506 | United States |
| Milwaukee | Wisconsin | 53233 | United States |
| Innsbruck | 6020 | Austria |
| Vienna | 1080 | Austria |
| Vienna | 1220 | Austria |
| Edmonton | Alberta | T6G 2B7 | Canada |
| Toronto | Ontario | M5T 2S8 | Canada |
| Regina | Saskatchewan | S4T 1A5 | Canada |
| Bordeaux | 33076 | France |
| Bron | 69677 | France |
| Clermont-Ferrand | 63003 | France |
| Lille | 59037 | France |
| Marseille | 13385 | France |
| Montpellier | 34295 | France |
| Poitiers | 86021 | France |
| Rennes | 35033 | France |
| Rouen | 76031 | France |
| Strasbourg | 67098 | France |
| Toulouse | 31059 | France |
| München | Bavaria | 80804 | Germany |
| München | Bavaria | 81675 | Germany |
| Beelitz-Heilstätten | Brandenburg | 14547 | Germany |
| Göttingen | Lower Saxony | 37075 | Germany |
| Leipzig | Saxony | 04103 | Germany |
| Gera | Thuringia | 07751 | Germany |
| Stadtroda | Thuringia | 07646 | Germany |
| Berlin | 12163 | Germany |
| Berlin | 13353 | Germany |
| Hamburg | 22291 | Germany |
| Kassel | 34128 | Germany |
| Marburg | 35043 | Germany |
| Barcelona | 08028 | Spain |
| Barcelona | 08035 | Spain |
| Barcelona | 08036 | Spain |
| Barcelona | 08041 | Spain |
| 16154788 | Background | da Silva-Junior FP, Braga-Neto P, Sueli Monte F, de Bruin VM. Amantadine reduces the duration of levodopa-induced dyskinesia: a randomized, double-blind, placebo-controlled study. Parkinsonism Relat Disord. 2005 Nov;11(7):449-52. doi: 10.1016/j.parkreldis.2005.05.008. Epub 2005 Sep 9. |
| 4919119 | Background | Dallos V, Heathfield K, Stone P, Allen FA. Use of amantadine in Parkinson's disease. Results of a double-blind trial. Br Med J. 1970 Oct 3;4(5726):24-6. doi: 10.1136/bmj.4.5726.24. |
| 18821084 | Background | Del Sorbo F, Albanese A. Levodopa-induced dyskinesias and their management. J Neurol. 2008 Aug;255 Suppl 4:32-41. doi: 10.1007/s00415-008-4006-5. |
| 18480609 | Background | Encarnacion EV, Hauser RA. Levodopa-induced dyskinesias in Parkinson's disease: etiology, impact on quality of life, and treatments. Eur Neurol. 2008;60(2):57-66. doi: 10.1159/000131893. Epub 2008 May 15. |
| 10348482 | Background | Factor SA, Molho ES. Transient benefit of amantadine in Parkinson's disease: the facts about the myth. Mov Disord. 1999 May;14(3):515-7. doi: 10.1002/1531-8257(199905)14:33.0.co;2-z. No abstract available. |
| 19025759 | Background | Goetz CG, Nutt JG, Stebbins GT. The Unified Dyskinesia Rating Scale: presentation and clinimetric profile. Mov Disord. 2008 Dec 15;23(16):2398-403. doi: 10.1002/mds.22341. |
| 19025984 | Background | Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340. |
| 23390076 | Background | Goetz CG, Stebbins GT, Chung KA, Hauser RA, Miyasaki JM, Nicholas AP, Poewe W, Seppi K, Rascol O, Stacy MA, Nutt JG, Tanner CM, Urkowitz A, Jaglin JA, Ge S. Which dyskinesia scale best detects treatment response? Mov Disord. 2013 Mar;28(3):341-6. doi: 10.1002/mds.25321. Epub 2013 Feb 6. |
| 7347558 | Background | Hayden FG, Gwaltney JM Jr, Van de Castle RL, Adams KF, Giordani B. Comparative toxicity of amantadine hydrochloride and rimantadine hydrochloride in healthy adults. Antimicrob Agents Chemother. 1981 Feb;19(2):226-33. doi: 10.1128/AAC.19.2.226. |
| Background | Jackson G, Stanley E, Lee Muldoon R. Chemoprophylaxis of viral respiratory diseases. Bulletin Pan Am Health Org. 1967; 147: 595-603. |
| 11009193 | Background | Luginger E, Wenning GK, Bosch S, Poewe W. Beneficial effects of amantadine on L-dopa-induced dyskinesias in Parkinson's disease. Mov Disord. 2000 Sep;15(5):873-8. doi: 10.1002/1531-8257(200009)15:53.0.co;2-i. |
| 24371304 | Background | Ory-Magne F, Corvol JC, Azulay JP, Bonnet AM, Brefel-Courbon C, Damier P, Dellapina E, Destee A, Durif F, Galitzky M, Lebouvier T, Meissner W, Thalamas C, Tison F, Salis A, Sommet A, Viallet F, Vidailhet M, Rascol O; NS-Park CIC Network. Withdrawing amantadine in dyskinetic patients with Parkinson disease: the AMANDYSK trial. Neurology. 2014 Jan 28;82(4):300-7. doi: 10.1212/WNL.0000000000000050. Epub 2013 Dec 26. |
| 11487209 | Background | Paci C, Thomas A, Onofrj M. Amantadine for dyskinesia in patients affected by severe Parkinson's disease. Neurol Sci. 2001 Feb;22(1):75-6. doi: 10.1007/s100720170054. |
| 4192093 | Background | Parkes JD, Zilkha KJ, Marsden P, Baxter RC, Knill-Jones RP. Amantadine dosage in treatment of Parkinson's disease. Lancet. 1970 May 30;1(7657):1130-3. doi: 10.1016/s0140-6736(70)91211-0. No abstract available. |
| 21217832 | Background | Sawada H, Oeda T, Kuno S, Nomoto M, Yamamoto K, Yamamoto M, Hisanaga K, Kawamura T; Amantadine Study Group. Amantadine for dyskinesias in Parkinson's disease: a randomized controlled trial. PLoS One. 2010 Dec 31;5(12):e15298. doi: 10.1371/journal.pone.0015298. |
| 11050029 | Background | Schrag A, Quinn N. Dyskinesias and motor fluctuations in Parkinson's disease. A community-based study. Brain. 2000 Nov;123 ( Pt 11):2297-305. doi: 10.1093/brain/123.11.2297. |
| 4677928 | Background | Schwab RS, Poskanzer DC, England AC Jr, Young RR. Amantadine in Parkinson's disease. Review of more than two years' experience. JAMA. 1972 Nov 13;222(7):792-5. doi: 10.1001/jama.222.7.792. No abstract available. |
| 10803797 | Background | Snow BJ, Macdonald L, Mcauley D, Wallis W. The effect of amantadine on levodopa-induced dyskinesias in Parkinson's disease: a double-blind, placebo-controlled study. Clin Neuropharmacol. 2000 Mar-Apr;23(2):82-5. doi: 10.1097/00002826-200003000-00004. |
| 16513858 | Background | Spencer TJ, Biederman J, Ciccone PE, Madras BK, Dougherty DD, Bonab AA, Livni E, Parasrampuria DA, Fischman AJ. PET study examining pharmacokinetics, detection and likeability, and dopamine transporter receptor occupancy of short- and long-acting oral methylphenidate. Am J Psychiatry. 2006 Mar;163(3):387-95. doi: 10.1176/appi.ajp.163.3.387. |
| 11864720 | Background | Swanson JM, Volkow ND. Pharmacokinetic and pharmacodynamic properties of stimulants: implications for the design of new treatments for ADHD. Behav Brain Res. 2002 Mar 10;130(1-2):73-8. doi: 10.1016/s0166-4328(01)00433-8. |
| 14707325 | Background | Thomas A, Iacono D, Luciano AL, Armellino K, Di Iorio A, Onofrj M. Duration of amantadine benefit on dyskinesia of severe Parkinson's disease. J Neurol Neurosurg Psychiatry. 2004 Jan;75(1):141-3. |
| 5317962 | Background | Tyrrell DA, Bynoe ML, Hoorn B. Studies on the antiviral activity of 1-adamantanamine. Br J Exp Pathol. 1965 Aug;46(4):370-5. No abstract available. |
| 9595981 | Background | Verhagen Metman L, Del Dotto P, van den Munckhof P, Fang J, Mouradian MM, Chase TN. Amantadine as treatment for dyskinesias and motor fluctuations in Parkinson's disease. Neurology. 1998 May;50(5):1323-6. doi: 10.1212/wnl.50.5.1323. |
| 10555659 | Background | Metman LV, Del Dotto P, LePoole K, Konitsiotis S, Fang J, Chase TN. Amantadine for levodopa-induced dyskinesias: a 1-year follow-up study. Arch Neurol. 1999 Nov;56(11):1383-6. doi: 10.1001/archneur.56.11.1383. |
| 9766762 | Background | Volkow ND, Wang GJ, Fowler JS, Gatley SJ, Logan J, Ding YS, Hitzemann R, Pappas N. Dopamine transporter occupancies in the human brain induced by therapeutic doses of oral methylphenidate. Am J Psychiatry. 1998 Oct;155(10):1325-31. doi: 10.1176/ajp.155.10.1325. |
| 20198649 | Background | Wolf E, Seppi K, Katzenschlager R, Hochschorner G, Ransmayr G, Schwingenschuh P, Ott E, Kloiber I, Haubenberger D, Auff E, Poewe W. Long-term antidyskinetic efficacy of amantadine in Parkinson's disease. Mov Disord. 2010 Jul 30;25(10):1357-63. doi: 10.1002/mds.23034. |
| 20090375 | Background | Wright Willis A, Evanoff BA, Lian M, Criswell SR, Racette BA. Geographic and ethnic variation in Parkinson disease: a population-based study of US Medicare beneficiaries. Neuroepidemiology. 2010;34(3):143-51. doi: 10.1159/000275491. Epub 2010 Jan 15. |
| 28777755 | Derived | Hauser RA, Pahwa R, Tanner CM, Oertel W, Isaacson SH, Johnson R, Felt L, Stempien MJ. ADS-5102 (Amantadine) Extended-Release Capsules for Levodopa-Induced Dyskinesia in Parkinson's Disease (EASE LID 2 Study): Interim Results of an Open-Label Safety Study. J Parkinsons Dis. 2017;7(3):511-522. doi: 10.3233/JPD-171134. |
| FG002 | Group 2 | Subjects in Group 2 completed previous LID study, enrolled ADS-AMT-PD302 after a time gap. |
| FG003 | Group 3 | Subjects were not in a previous Adamas LID study and had prior DBS (deep brain stimulation) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1a | Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1A received ADS-5102 in the prior study. |
| BG001 | Group 1P | Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1P received placebo in the prior study |
| BG002 | Group 2 | Subjects in Group 2 completed previous LID study, enrolled ADS-AMT-PD302 after a time gap. |
| BG003 | Group 3 | Subjects were not in a previous Adamas LID study and had prior DBS (deep brain stimulation) |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| eGFR | Mean | Standard Deviation | mL/min/1.73 m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations | The primary objective of the study was to evaluate the safety and tolerability of ADS-5102 oral capsules, an extended release (ER) formulation of amantadine, administered at a dose of 340 mg once daily at bedtime for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). | Posted | Count of Participants | Participants | Up to 101 weeks |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores) | To evaluate clinical progression of PD as assessed by the MDS-UPDRS, combined score, Parts I, II, and III. Part I - non-motor experiences of daily living; Part II - motor experiences of daily living; Part III - motor examination. Parts I and II each contain 13 questions measured on a 5-point scale (0-4). Part III contains 18 objective rater assessments of the motor signs of PD measured on a 5-point scale (0-4). Total range for combined score (Part I-III) is = 0-176. Generally for MDS-UPDRS scores and sub-scores, the lower the score, the better. Parts I, II, and III are summed to make the total score. | Posted | Mean | Standard Deviation | units on a scale | Up to 101 weeks. MDS-UPDRS was performed at the following visits: Screening, Week 8, Week 16, Week 28, Week 40, Week 52, Week 64, Week 76, Week 88, Week 100 (or ET). |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications) | This component (Questions 4.1 - 4.6) includes time spent with dyskinesia, functional impact of dyskinesia, time spent in OFF state, functional impact of fluctuations, complexity of motor fluctuations, painful OFF-state dystonia. Questions 4.1-4.6 are summed to make the Part IV score. Generally for MDS-UPDRS scores and sub-scores, the lower the score, the better. Total range for Part IV is = 0-24 | Posted | Mean | Standard Deviation | units on a scale | 100 Weeks. MDS-UPDRS was performed at the following visits: Screening, Week 8, Week 16, Week 28, Week 40, Week 52, Week 64, Week 76, Week 88, Week 100 (or ET). |
|
100 weeks
Safety was assessed through adverse events (AEs), physical examinations, vital signs, and laboratory parameters (hematology, serum chemistry, urinalysis, and pregnancy testing, if appropriate).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1a | Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1A received ADS-5102 in the prior study. | 4 | 60 | 16 | 60 | 47 | 60 |
| EG001 | Group 1P | Subjects completed previous LID study and enrolled in ADS-AMT-PD302 study immediately. Subjects in Group 1P received placebo in the prior study | 2 | 78 | 21 | 78 | 61 | 78 |
| EG002 | Group 2 | Subjects in Group 2 completed previous LID study, enrolled ADS-AMT-PD302 after a time gap. | 2 | 24 | 6 | 24 | 21 | 24 |
| EG003 | Group 3 | Subjects were not in a previous Adamas LID study and had prior DBS (deep brain stimulation) | 1 | 61 | 17 | 61 | 45 | 61 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment | Acute colitis |
|
| Ostenecrosis | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment | Avascular necrosis of the right patella |
|
| Arthritis bacteria | Infections and infestations | MedDRA (17.0) | Systematic Assessment | Septic right knee requiring right total nee arthroplasty |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA (17.0) | Systematic Assessment | Non-St-Elevation mycardial infarction |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA (17.0) | Systematic Assessment | Supraventricular tachycardia |
|
| Volvulus | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment | Sigmoid, volvulus |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment | Worsening right knee degenerative disease |
|
| Colonic pseudo-obstruction | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment | Oglive Syndrome |
|
| Clostridium difficile sepsis | Infections and infestations | MedDRA (17.0) | Systematic Assessment | C. diff sepsis |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment | Left knee laceration |
|
| Constipation | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment | Slow transit constipation |
|
| Psychiatric disorder | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment | Psychosis |
|
| Septic shock | Infections and infestations | MedDRA (17.0) | Systematic Assessment | Septic shock |
|
| Encephalopathy | Nervous system disorders | MedDRA (17.0) | Systematic Assessment | Encephalopathy |
|
| Lymphoadenopathy | Nervous system disorders | MedDRA (17.0) | Systematic Assessment | Lymphoadenopathy |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment | Right distal radius fracture |
|
| Adenocarcinoma of the colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment | Adenocarcinoma of the ascending colon (right) |
|
| Confusional state | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment | Acute confusional syndrome |
|
| Pseudomonal sepsis | Infections and infestations | MedDRA (17.0) | Systematic Assessment | Pseudomona aeruginosa sepsis |
|
| Neuroleptic malignant syndrome | Nervous system disorders | MedDRA (17.0) | Systematic Assessment | Malignant neuroleptic syndrome |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment | Intestinal oclusion |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment | Ribs fracture |
|
| Parkinson's disease | Nervous system disorders | MedDRA (17.0) | Systematic Assessment | Worsening of Parkinson's disease |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment | Shoulder luxation |
|
| Cardiac arrest | Cardiac disorders | MedDRA (17.0) | Systematic Assessment | Cardiac arrest |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment | Comminuted intertrichanteric right hip fracture |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment | Fractured right ankle |
|
| Urinary tract infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment | Persistent urinary tract infection |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment | Rhabdomyolysis |
|
| Angina pectoris | Cardiac disorders | MedDRA (17.0) | Systematic Assessment | Cardiac chest pain (etiology unknown) |
|
| Adverse drug reaction | General disorders | MedDRA (17.0) | Systematic Assessment | Adverse drug reaction to melatonin and stool softner |
|
| Myocardial infarction | Cardiac disorders | MedDRA (17.0) | Systematic Assessment | Heart attack |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment | Left hip fracture |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment | Left intertrochanteric femur fracture |
|
| Arrhythmia | Cardiac disorders | MedDRA (17.0) | Systematic Assessment | Cardiac arrhythmia |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment | Intestinal obstruction |
|
| Suicide attempt | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment | Attempted suicide |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment | Respiratory arrest |
|
| Coronary artery disease | Cardiac disorders | MedDRA (17.0) | Systematic Assessment | Angina pectoris due to coronary vascular disease |
|
| Paraesthesia | Nervous system disorders | MedDRA (17.0) | Systematic Assessment | Paraesthesia |
|
| Traumatic fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment | Traumatic serial rib fractures |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment | Hemothorax |
|
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment | Acetabulum fracture right |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment | Fractured pelvis |
|
| On and Off Phenomenon | Nervous system disorders | MedDRA (17.0) | Systematic Assessment | Worsening motor fluctuations related to PD |
|
| Confusion postoperative | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment | Confusion after hip prothesis surgery |
|
| Restless leg syndrome | Nervous system disorders | MedDRA (17.0) | Systematic Assessment | Worsening of restless leg syndrome |
|
| Constipation | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment | Abdominal pain (obstipation) |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment | Left wrist fracture |
|
| Pneumonia | Infections and infestations | MedDRA (17.0) | Systematic Assessment | Pneumonia |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA (17.0) | Systematic Assessment | MRSA bacteremia, presumably due to infected hardware |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment | Respiratory distress secondary to pneumonia |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment | Worsening of right knee pain |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment | Worsening benign prostatic hypertrophy |
|
| Cellulitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment | Cellulitis - right leg |
|
| Mental status changes | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment | Altered mental status |
|
| Death | General disorders | MedDRA (17.0) | Systematic Assessment | Death due to natural causes |
|
| Sepsis | Infections and infestations | MedDRA (17.0) | Systematic Assessment | Sepsis |
|
| Traumatic fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment | Right tibial fracture - motor vehicle accident |
|
| Confusional state | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment | Altered mental state, confusion (occurred 30 days after the last dose) |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment | Broken ankle (left) |
|
| Anxiety | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment | Worsening anxiety |
|
| Suicidal ideation | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment | Suicidal ideation with intent for self harm |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment | Dysfunction of deep brain stimulation device with increased disposition to fall |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA (17.0) | Systematic Assessment | Benign paroxysmal positional vertigo |
|
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment | Craniocerebral injury |
|
| Hypokinesia | Nervous system disorders | MedDRA (17.0) | Systematic Assessment | Hypokinesis |
|
| Intercostal neuralgia | Nervous system disorders | MedDRA (17.0) | Systematic Assessment | Intercostal neuralgia |
|
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment | Forearm fracture left |
|
| Hypertensive crisis | Vascular disorders | MedDRA (17.0) | Systematic Assessment | Hypertensive crisis |
|
| Hypersensitivity | Immune system disorders | MedDRA (17.0) | Systematic Assessment | Tongue swelling due to allergic reaction |
|
| Venous thrombosis | Vascular disorders | MedDRA (17.0) | Systematic Assessment | Thrombosis of the vena saphena magna in the thigh and lower leg left side |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA (17.0) | Systematic Assessment | Semi-myocardial infarction |
|
| Parkinson's disease | Nervous system disorders | MedDRA (17.0) | Systematic Assessment | Parkinsonism aggravation |
|
| Hypertensive cardiomyopathy | Cardiac disorders | MedDRA (17.0) | Systematic Assessment | Hypertensive cardiomyopathy |
|
| Abasia | General disorders | MedDRA (17.0) | Systematic Assessment | Unable to walk |
|
| Myocardial infarction | Cardiac disorders | MedDRA (17.0) | Systematic Assessment | Anterior myocardial infarction with acute pulmonary edema |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment | Left knee join effusion |
|
| Mania | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment | Acute psychiatric disorder (maniac manifestation) |
|
| Dyskinesia | Nervous system disorders | MedDRA (17.0) | Systematic Assessment | Worsening of dyskinesia (reassessment about alternative therapeutic) |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment | Epigastralgia |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment | Fall |
|
| Hallucination (pooled) | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment | Hallucination (Pooled = combines all Preferred terms that contain the term "Hallucination." |
|
| Hallucination, visual | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Edema peripheral | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Livedo reticularis | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| On and off phenomenon | Nervous system disorders | MedDRA (17.0) | Systematic Assessment | These events were worsening of disease over the duration of the study |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA (17.0) | Systematic Assessment | Worsening of Parkinson's disease |
|
| Anxiety | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypertension | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Reed Johnson | Adamas Pharmaceuticals, Inc. | 510-450-3500 | rjohnson@adamaspharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 13, 2015 | Jul 8, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D010300 | Parkinson Disease |
| D020734 | Parkinsonian Disorders |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Study drug-related AE |
|
| SAEs |
|
| Permanent discontinuation due to AE |
|
| Permanent discontinuation due to drug-related AE |
|
| Mild AEs |
|
| Moderate AEs |
|
| Mild drug-related AE |
|
| Moderate drug-related AE |
|
| Severe drug-related AE |
|
| OG003 | ADS-5102 Group 3 | Subjects who would have been deemed ineligible for participation in a previous Adamas efficacy study due to having undergone DBS |
|
|
| OG003 | Group 3 | Subjects were not in a previous Adamas LID study and had prior DBS (deep brain stimulation) |
|
|