A Phase 3 interventional study of ADS-5102 in Dyskinesia, Levodopa Induced Dyskinesia (LID) and Parkinson's Disease (PD), sponsored by Adamas Pharmaceuticals, Inc.. Completed at 87 sites in 6 countries. Open to participants aged 30 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-10-06.
Sponsored by Adamas Pharmaceuticals, Inc. (part of Supernus Pharmaceuticals, Inc.) · Phase 3, Interventional, and Treatment
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Among 101 studies in Dyskinesias with a site in United States — 8 open to participants now, 9 under way, 1 of them phase 3. Dyskinesias · United States.
Among the 101 studies in Dyskinesias with a site in United States, this one is the 15th largest by enrollment of the 82 interventional ones that give a count, is one of 9 that started in 2014, is one of 24 in phase 3, and was the 67th registered.
179 studies on the registry are indexed under Dyskinesias; 24 are open to participants now.
Browse Dyskinesias studies →8 of the 101 studies in Dyskinesias with a site in United States are open now. Recruiting first, the newest first:
Appello Pharmaceuticals, Inc. · Sites in United States
Ages 30–80
U: The Mind Company · Sites in United States
Ages 18–80
Boston Children's Hospital · Sites in United States
Ages 0–30
Boston Children's Hospital · Sites in United States
Ages 0–18
Boston Children's Hospital · Sites in United States
Ages 0–18
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 16 Dyskinesias studies recruiting now, 4 (25%) set no upper age limit and 8 (50%) stop at 75 or younger; 5 take children under 18; 2 take healthy volunteers.
This study: 30 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
101 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 38 · Phase 3 28 · Phase 4 3
First in 1999; this study’s year is marked. 9 started in 2014.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 223 is above the median of 36 across 139 interventional studies indexed under Dyskinesias.
Median enrollment 41 across the 82 interventional studies, 36 across the 18 observational. Of the 85 that completed or were terminated, 33 (39%) have results posted.
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58 of 101 have an industry lead sponsor. The 10 most frequent:
This study is registered under Adamas Pharmaceuticals, Inc., one of the names counted as Supernus Pharmaceuticals, Inc.. Under that name alone:
Adamas Pharmaceuticals, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
Supernus Pharmaceuticals, Inc. has 7 studies filed under Dyskinesias — fewer than ten, so there is no comparison to draw.
2 of the studies in Dyskinesias with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06618157Duke UniversityConnectomic Guided DBS for Parkinson's Disease | 2026-12-29 |
| NCT07432958Appello Pharmaceuticals, Inc.A Study to Evaluate the Effectiveness of Two Doses of AP-472 as Adjunctive Therapy to Levodopa in Parkinson's Disease (PD) Participants With Motor Fluctuations | 2027-09-03 |
Add all 2 to your calendar (.ics) → With an account.
Among the 101 studies in Dyskinesias with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
amantadine HCl extended release
Drug: ADS-5102
Also known as: amantadine HCl extended release
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).
Time frame: Up to 101 weeks
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.
Time frame: 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
Time frame: 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).
| Milestone | Group 1a | Group 1P | Group 2 | Group 3 |
|---|---|---|---|---|
| Started | 60 | 78 | 24 | 61 |
| Completed | 35 | 41 | 14 | 39 |
| Not completed | 25 | 37 | 10 | 22 |
| Withdrew: Adverse event | 8 | 19 | 5 | 9 |
| Withdrew: Death | 3 | 2 | 1 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 | 1 |
| Withdrew: Needed to take excluded medication | 0 | 2 | 0 | 1 |
| Withdrew: Subject moved away | 0 | 1 | 0 | 0 |
| Withdrew: Dbs surgery | 3 | 0 | 0 | 0 |
| Withdrew: Dyskinesia upon taper | 1 | 0 | 0 | 0 |
| Withdrew: Lack of efficacy | 0 | 1 | 0 | 0 |
| Withdrew: Physician decision | 1 | 0 | 0 | 0 |
| Withdrew: Site closure | 3 | 0 | 0 | 1 |
| Withdrew: Unable to complete visits per protocol | 1 | 0 | 0 | 0 |
| Withdrew: Worsening dyskinesia | 0 | 0 | 0 | 1 |
| Withdrew: Protocol violation | 0 | 1 | 0 | 0 |
| Withdrew: Sponsor's decision | 2 | 0 | 0 | 0 |
| Withdrew: Subject unwilling to proceed | 1 | 5 | 3 | 5 |
| Withdrew: Subject consent withdrawn | 0 | 3 | 1 | 2 |
| Withdrew: Egfr<50ml/min/m2 | 2 | 2 | 0 | 1 |
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).
| Participants | Group 1a | Group 1P | Group 2 | Group 3 |
|---|---|---|---|---|
| AE | 57 | 70 | 23 | 55 |
| Study drug-related AE | 31 | 45 | 16 | 32 |
| SAEs | 16 | 21 | 6 | 17 |
| Permanent discontinuation due to AE | 12 | 21 | 6 | 10 |
| Permanent discontinuation due to drug-related AE | 4 | 15 | 4 | 8 |
| Mild AEs | 12 | 13 | 3 | 11 |
| Moderate AEs | 25 | 36 | 13 | 26 |
| Mild drug-related AE | 16 | 15 | 3 | 5 |
| Moderate drug-related AE | 12 | 23 | 12 | 22 |
| Severe drug-related AE | 3 | 7 | 1 | 5 |
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.
| units on a scale | ADS-5102 1A | ADS-5102 Group 1P | ADS-5102 Group 2 | ADS-5102 Group 3 |
|---|---|---|---|---|
| Baseline | 41.8 ± 18.43 | 45.6 ± 19.24 | 52.8 ± 23.06 | 52.4 ± 16.55 |
| Change from Baseline at Week 8 | 1.2 ± 10.03 | -2.8 ± 14.11 | 0.8 ± 12.00 | -5.3 ± 10.74 |
| Change from Baseline at Week 16 | 1.6 ± 13.41 | -1.4 ± 16.22 | 5.7 ± 15.53 | -5.2 ± 11.33 |
| Change from Baseline at Week 28 | 4.8 ± 10.04 | 1.5 ± 12.49 | 6.5 ± 14.18 | -5.3 ± 12.99 |
| Change from Baseline at Week 40 | 7.5 ± 15.43 | -0.4 ± 15.20 | 1.6 ± 18.29 | -4.8 ± 12.49 |
| Change from Baseline at Week 52 | 13.2 ± 16.78 | 2.6 ± 14.57 | 6.1 ± 18.34 | -4.6 ± 15.60 |
| Change from Baseline at Week 64 | 8.8 ± 14.83 | 2.6 ± 14.57 | 6.1 ± 18.34 | -4.6 ± 15.60 |
| Change from Baseline at Week 76 | 11.7 ± 19.58 | 7.3 ± 19.18 | 9.4 ± 19.10 | -4.9 ± 13.83 |
| Change from Baseline at Week 88 | 11.3 ± 16.65 | 3.7 ± 13.80 | 6.4 ± 22.65 | 0.9 ± 16.18 |
| Change from Baseline at Week 100 | 11.4 ± 15.66 | 3.7 ± 15.29 | 6.5 ± 16.46 | 4.1 ± 17.48 |
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
| units on a scale | Group 1a | Group 1P | Group 2 | Group 3 |
|---|---|---|---|---|
| Baseline | 6.5 ± 3.38 | 9.6 ± 3.07 | 9.8 ± 3.92 | 10.4 ± 2.77 |
| Change in Baseline from Week 8 | -0.2 ± 3.21 | -3.4 ± 3.27 | -3.6 ± 4.16 | -4.0 ± 4.20 |
| Change in Baseline from Week 16 | -0.8 ± 3.61 | -3.2 ± 3.61 | -1.1 ± 5.03 | -3.9 ± 3.68 |
| Change from Baseline at Week 28 | -0.3 ± 3.61 | -3.3 ± 3.12 | -1.4 ± 3.84 | -4.4 ± 3.79 |
| Change from Baseline at Week 40 | 0.0 ± 3.95 | -2.8 ± 3.39 | -2.9 ± 4.81 | -4.7 ± 4.06 |
| Change from Baseline at Week 52 | 0.2 ± 3.64 | -2.9 ± 3.56 | -2.5 ± 4.40 | -3.6 ± 3.62 |
| Change from Baseline at Week 64 | 0.4 ± 3.82 | -3.3 ± 3.42 | -1.9 ± 4.32 | -2.5 ± 4.22 |
| Change from Baseline at Week 76 | 0.9 ± 4.20 | -2.9 ± 3.67 | -2.7 ± 3.90 | -3.7 ± 3.68 |
| Change from Baseline at Week 88 | 0.4 ± 3.77 | -2.8 ± 3.60 | -3.7 ± 4.69 | -4.3 ± 3.55 |
| Change from Baseline at Week 100 | 0.4 ± 3.28 | -2.4 ± 4.19 | -3.6 ± 3.66 | -3.6 ± 3.94 |
Collected over 100 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1a | 4/60 (6.7%) | 16/60 (26.7%) | 47/60 (78.3%) |
| Group 1P | 2/78 (2.6%) | 21/78 (26.9%) | 61/78 (78.2%) |
| Group 2 | 2/24 (8.3%) | 6/24 (25%) | 21/24 (87.5%) |
| Group 3 | 1/61 (1.6%) | 17/61 (27.9%) | 45/61 (73.8%) |
| Event | Group 1a | Group 1P | Group 2 | Group 3 |
|---|---|---|---|---|
| Wrist fractureInjury, poisoning and procedural complications | 0/60 | 0/78 | 1/24 | 0/61 |
| PneumoniaInfections and infestations | 0/60 | 0/78 | 1/24 | 0/61 |
| Staphylococcal sepsisInfections and infestations | 0/60 | 0/78 | 1/24 | 0/61 |
| Respiratory distressRespiratory, thoracic and mediastinal disorders | 0/60 | 0/78 | 1/24 | 0/61 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/60 | 0/78 | 1/24 | 0/61 |
| Benign prostatic hyperplasiaReproductive system and breast disorders | 0/60 | 0/78 | 1/24 | 0/61 |
| CellulitisInfections and infestations | 0/60 | 0/78 | 1/24 | 0/61 |
| Mental status changesPsychiatric disorders | 0/60 | 0/78 | 1/24 | 0/61 |
| DeathGeneral disorders | 0/60 | 0/78 | 1/24 | 0/61 |
| SepsisInfections and infestations | 0/60 | 0/78 | 1/24 | 1/61 |
| Event | Group 1a | Group 1P | Group 2 | Group 3 |
|---|---|---|---|---|
| FallInjury, poisoning and procedural complications | 13/60 | 29/78 | 8/24 | 23/61 |
| Hallucination (pooled)Psychiatric disorders | 15/60 | 24/78 | 5/24 | 10/61 |
| Hallucination, visualPsychiatric disorders | 14/60 | 24/78 | 4/24 | 10/61 |
| ConstipationGastrointestinal disorders | 9/60 | 12/78 | 6/24 | 3/61 |
| NauseaGastrointestinal disorders | 7/60 | 8/78 | 6/24 | 1/61 |
| DizzinessNervous system disorders | 4/60 | 10/78 | 5/24 | 3/61 |
| Edema peripheralGeneral disorders | 10/60 | 12/78 | 2/24 | 12/61 |
| InsomniaPsychiatric disorders | 8/60 | 5/78 | 4/24 | 4/61 |
| On and off phenomenonNervous system disorders | 7/60 | 4/78 | 4/24 | 3/61 |
| Dry mouthGastrointestinal disorders | 4/60 | 6/78 | 4/24 | 3/61 |
| Age, Categorical(Participants) | Group 1a | Group 1P | Group 2 | Group 3 | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 28 | 30 | 12 | 39 | 109 |
| >=65 years | 32 | 48 | 12 | 22 | 114 |
| Age, Continuous(years) | Group 1a | Group 1P | Group 2 | Group 3 | Total |
|---|---|---|---|---|---|
| Mean | 64.0 ± 9.81 | 65.9 ± 8.80 | 64.4 ± 7.81 | 60.2 ± 9.20 | 63.7 ± 9.32 |
| Sex: Female, Male(Participants) | Group 1a | Group 1P | Group 2 | Group 3 | Total |
|---|---|---|---|---|---|
| Female | 26 | 33 | 13 | 20 | 92 |
| Male | 34 | 45 | 11 | 41 | 131 |
| Race (NIH/OMB)(Participants) | Group 1a | Group 1P | Group 2 | Group 3 | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 2 | 2 | 0 | 4 | 8 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 1 | 1 | 2 |
| White | 57 | 74 | 23 | 54 | 208 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 2 | 0 | 2 | 5 |
| Body Mass Index(kg/m^2) | Group 1a | Group 1P | Group 2 | Group 3 | Total |
|---|---|---|---|---|---|
| Mean | 25.86 ± 25.42 | 25.72 ± 24.63 | 25.26 ± 23.24 | 27.29 ± 4.891 | 26.14 ± 5.220 |
| eGFR(mL/min/1.73 m^2) | Group 1a | Group 1P | Group 2 | Group 3 | Total |
|---|---|---|---|---|---|
| Mean | 88.7 ± 24.31 | 92.2 ± 19.64 | 96.3 ± 20.54 | 92.1 ± 19.95 | 91.6 ± 21.16 |
PDFs hosted by the registry, ClinicalTrials.gov.
The record gives a start of Jul 2014, a primary completion of Feb 2018 and a completion of Feb 2018. It does not say whether these dates are actual or estimated.
Results were first posted in Sep 2020, 2 years 7 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Adamas Pharmaceuticals, Inc. →