A Phase 3 interventional study of ADS-5102 and Placebo in Dyskinesia, Levodopa Induced Dyskinesia (LID) and Parkinson's Disease, sponsored by Adamas Pharmaceuticals, Inc.. Completed at 46 sites in 2 countries. Open to participants aged 30 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-02-06.
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 22nd 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 61st 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 126 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 |
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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 multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, dosed once nightly at bedtime 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) maximal concentrations in the early morning through mid-day, when LID can be troublesome, and ii) lower concentrations in the evening, potentially reducing the negative impact of amantadine on sleep. This pharmacokinetic profile could enable higher doses to be tolerated with a once-nightly ER formulation than can be tolerated with an immediate-release formulation. The once-nightly dosing regimen may also provide enhanced convenience and compliance.
In a previous clinical study, ADS-5102 met its primary endpoint; LID was significantly reduced as measured by the change in UDysRS score over 8 weeks vs. placebo.
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.
ADS-5102 (amantadine HCl extended release)
Drug: ADS-5102
Placebo
Other: Placebo
Oral capsules to be administered once nightly at bedtime, for 25 weeks
Also known as: amantadine HCl extended release
Oral capsules to be administered once nightly at bedtime, for 25 weeks
Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 12
The UDysRS is a dyskinesia rating scale from 0-104; it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The UDysRS was measured at Baseline and Weeks 2, 8, 12, 18, and 24.
Time frame: Baseline to Week 12
Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 24
The UDysRS is a dyskinesia rating scale from 0-104; it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The UDysRS was measured at Baseline and Weeks 2, 8, 12, 18, and 24.
Time frame: Baseline to Week 24
Change in the Standardized PD Home Diary (ON Time Without Troublesome Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time)
A PD home diary was used to score 5 different conditions in 30-minute intervals: ASLEEP, OFF, ON (ie, had adequate control of PD symptoms) without dyskinesia, ON with non-troublesome dyskinesia, and ON with troublesome dyskinesia. The results were based on 2 consecutive 24-hour diaries taken prior to the day of randomization and prior to the Week 2, 8, 12, 18, and 24 visits.
Time frame: Baseline (BL) to Week 12 (W12) and Week 24 (W24)
Change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Combined Score (Parts I, II, and III)
The MDS-UPDRS Parts I, II, and III examined non-motor experiences of daily living, motor experiences of daily living, and motor examination, respectively. Each Part contains items or questions that were each rated on a scale from 0 (normal) to 4 (severe). The Combined Parts I, II, and III (representing the sum of the individual scores from Parts I, II, and III) has a scale range of 0-236. Higher scores, whether for individual Parts or the sum of the combined Parts, indicate more severe PD.
Time frame: Baseline (BL) to Week 12 (W12) and Week 24 (W24)
Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms
The CGI-C consisted of a single question that assessed the investigator's global impression of the subject's change from Baseline in overall PD symptoms, including but not limited to LID. The CGI-C required that the investigator rate the extent to which the subject's PD had improved or worsened (from marked worsening to marked improvement). The CGI-C was assessed at Baseline and Weeks 2, 8, 12, 18, and 24.
Time frame: Baseline to Week 12 and Week 24
126 Participants with Parkinson's disease (PD) and Levodopa-induced Dyskinesia (LID) were randomized at 41 study sites in the United States and Canada. The first subject was randomized on 20 May 2014 and the last subject completed on 18 November 2015.
| Milestone | Placebo | ADS-5102 (340 mg) |
|---|---|---|
| Started | 63 | 63 |
| Received study drug | 60 | 63 |
| Completed | 42 | 42 |
| Not completed | 21 | 21 |
| Withdrew: Sponsor's decision to stop the study | 7 | 7 |
| Withdrew: Withdrawal by subject | 3 | 10 |
| Withdrew: Subject unwilling to proceed | 7 | 2 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Did not receive study drug | 2 | 0 |
| Withdrew: Lack of efficacy | 1 | 0 |
| Withdrew: Death | 0 | 1 |
The UDysRS is a dyskinesia rating scale from 0-104; it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The UDysRS was measured at Baseline and Weeks 2, 8, 12, 18, and 24.
| units on a scale | Placebo | ADS-5102 (340 mg) |
|---|---|---|
| Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 12 | -8.0 ± 1.64 | -15.9 ± 1.62 |
The UDysRS is a dyskinesia rating scale from 0-104; it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The UDysRS was measured at Baseline and Weeks 2, 8, 12, 18, and 24.
| units on a scale | Placebo | ADS-5102 (340 mg) |
|---|---|---|
| Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 24 | -6.3 ± 1.94 | -15.6 ± 1.87 |
A PD home diary was used to score 5 different conditions in 30-minute intervals: ASLEEP, OFF, ON (ie, had adequate control of PD symptoms) without dyskinesia, ON with non-troublesome dyskinesia, and ON with troublesome dyskinesia. The results were based on 2 consecutive 24-hour diaries taken prior to the day of randomization and prior to the Week 2, 8, 12, 18, and 24 visits.
| hours | Placebo | ADS-5102 (340 mg) |
|---|---|---|
| Change in ON time w/o troublesome dyskinesia (W12) | 0.82 ± 0.432 | 3.56 ± 0.434 |
| Change in ON time w/o troublesome dyskinesia (W24) | 1.37 ± 0.456 | 3.59 ± 0.440 |
| Change in OFF time (W12) | 0.32 ± 0.263 | -0.59 ± 0.265 |
| Change in OFF time (W24) | 0.22 ± 0.282 | -0.58 ± 0.268 |
| Change in ON time w/ troublesome dyskinesia (W12) | -1.58 ± 0.358 | -3.12 ± 0.359 |
| Change in ON time w/ troublesome dyskinesia (W24) | -1.86 ± 0.380 | -3.31 ± 0.363 |
The MDS-UPDRS Parts I, II, and III examined non-motor experiences of daily living, motor experiences of daily living, and motor examination, respectively. Each Part contains items or questions that were each rated on a scale from 0 (normal) to 4 (severe). The Combined Parts I, II, and III (representing the sum of the individual scores from Parts I, II, and III) has a scale range of 0-236. Higher scores, whether for individual Parts or the sum of the combined Parts, indicate more severe PD.
| units on a scale | Placebo | ADS-5102 (340 mg) |
|---|---|---|
| Change from BL at Week 12 | -4.0 ± 1.96 | -5.2 ± 1.92 |
| Change from BL at Week 24 | -3.5 ± 2.60 | -1.3 ± 2.45 |
The CGI-C consisted of a single question that assessed the investigator's global impression of the subject's change from Baseline in overall PD symptoms, including but not limited to LID. The CGI-C required that the investigator rate the extent to which the subject's PD had improved or worsened (from marked worsening to marked improvement). The CGI-C was assessed at Baseline and Weeks 2, 8, 12, 18, and 24.
| Participants | Placebo | ADS-5102 (340 mg) |
|---|---|---|
| Week 12 — Marked Improvement | 2 | 18 |
| Week 12 — Moderate Improvement | 9 | 20 |
| Week 12 — Minimal Improvement | 10 | 13 |
| Week 12 — No Change | 25 | 9 |
| Week 12 — Minimal Worsening | 10 | 2 |
| Week 12 — Moderate Worsening | 2 | 0 |
| Week 12 — Marked Worsening | 0 | 1 |
| Week 24 — Marked Improvement | 5 | 14 |
| Week 24 — Moderate Improvement | 10 | 17 |
| Week 24 — Minimal Improvement | 12 | 12 |
| Week 24 — No Change | 17 | 7 |
| Week 24 — Minimal Worsening | 6 | 5 |
| Week 24 — Moderate Worsening | 4 | 5 |
| Week 24 — Marked Worsening | 0 | 2 |
Collected over Baseline through Week 25. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/60 (0%) | 3/60 (5%) | 36/60 (60%) |
| ADS-5102 (340 mg) | 1/63 (1.6%) | 7/63 (11.1%) | 56/63 (88.9%) |
| Event | Placebo | ADS-5102 (340 mg) |
|---|---|---|
| Hip fractureInjury, poisoning and procedural complications | 2/60 | 1/63 |
| CellulitisInfections and infestations | 1/60 | 1/63 |
| Humerus fractureInjury, poisoning and procedural complications | 0/60 | 1/63 |
| PresyncopeNervous system disorders | 0/60 | 1/63 |
| Subdural haematomaInjury, poisoning and procedural complications | 0/60 | 1/63 |
| Small intestinal obstructionGastrointestinal disorders | 0/60 | 1/63 |
| ConstipationGastrointestinal disorders | 0/60 | 1/63 |
| Muscular weaknessMusculoskeletal and connective tissue disorders | 0/60 | 1/63 |
| ON and OFF phenomenonNervous system disorders | 0/60 | 1/63 |
| EncephalopathyNervous system disorders | 0/60 | 1/63 |
| Event | Placebo | ADS-5102 (340 mg) |
|---|---|---|
| Hallucination, any typePsychiatric disorders | 1/60 | 18/63 |
| Hallucination, visualPsychiatric disorders | 1/60 | 15/63 |
| Oedema peripheralGeneral disorders | 0/60 | 15/63 |
| DizzinessNervous system disorders | 0/60 | 14/63 |
| Dry mouthGastrointestinal disorders | 0/60 | 11/63 |
| FallInjury, poisoning and procedural complications | 5/60 | 10/63 |
| ConstipationGastrointestinal disorders | 3/60 | 9/63 |
| Urinary tract infectionInfections and infestations | 5/60 | 7/63 |
| AnxietyPsychiatric disorders | 1/60 | 6/63 |
| ContusionInjury, poisoning and procedural complications | 1/60 | 6/63 |
Safety Analysis Population
| Age, Categorical(Participants) | Placebo | ADS-5102 (340 mg) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 27 | 32 | 59 |
| >=65 years | 33 | 31 | 64 |
| Age, Continuous(years) | Placebo | ADS-5102 (340 mg) | Total |
|---|---|---|---|
| Mean | 65.6 ± 8.59 | 63.9 ± 9.43 | 64.7 ± 9.04 |
| Sex: Female, Male(Participants) | Placebo | ADS-5102 (340 mg) | Total |
|---|---|---|---|
| Female | 23 | 28 | 51 |
| Male | 37 | 35 | 72 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | ADS-5102 (340 mg) | Total |
|---|---|---|---|
| Hispanic or Latino | 9 | 3 | 12 |
| Not Hispanic or Latino | 51 | 60 | 111 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo | ADS-5102 (340 mg) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 2 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 1 | 0 | 1 |
| White | 53 | 60 | 113 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 0 | 3 |
| Unified Dyskinesia Rating Scale (UDysRS)(units on a scale) | Placebo | ADS-5102 (340 mg) | Total |
|---|---|---|---|
| Total Score | 38.2 ± 11.20 | 40.9 ± 13.34 | 39.6 ± 12.37 |
| Total Objective Score (Parts III, IV) | 15.3 ± 6.66 | 16.4 ± 7.72 | 15.9 ± 7.21 |
| PD Home Diary(hours) | Placebo | ADS-5102 (340 mg) | Total |
|---|---|---|---|
| Asleep | 8.02 ± 1.446 | 7.78 ± 1.732 | 7.90 ± 1.597 |
| Off | 2.94 ± 2.105 | 3.16 ± 2.372 | 3.05 ± 2.239 |
| ON without Troublesome Dyskinesia | 8.59 ± 2.815 | 8.34 ± 3.466 | 8.46 ± 3.155 |
| ON with Troublesome Dyskinesia | 4.46 ± 1.933 | 4.72 ± 2.537 | 4.59 ± 2.257 |
| Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(units on a scale) | Placebo | ADS-5102 (340 mg) | Total |
|---|---|---|---|
| Part I | 11.5 ± 4.17 | 12.5 ± 6.18 | 12.0 ± 5.31 |
| Part II | 15.8 ± 5.80 | 15.7 ± 6.77 | 15.8 ± 6.29 |
| Part III | 24.6 ± 12.10 | 25.9 ± 14.49 | 25.3 ± 13.34 |
| Combined Parts I, II, and III | 51.9 ± 16.95 | 54.2 ± 20.37 | 53.1 ± 18.75 |
| Part IV | 11.3 ± 2.36 | 11.8 ± 2.95 | 11.6 ± 2.68 |
| Part IV, Item 4.1 | 2.4 ± 0.82 | 2.6 ± 0.94 | 2.5 ± 0.89 |
| Part IV, Item 4.2 | 2.5 ± 0.54 | 2.6 ± 0.56 | 2.5 ± 0.55 |
5 further baseline measures are reported on the registry.
The record gives a start of May 2014, a primary completion of Dec 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Feb 2018, 2 years 2 months after primary completion. A results delay was requested in Feb 2017.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Adamas Pharmaceuticals, Inc. →