A Phase 3 interventional study of ADS-5102, 274 mg in Multiple Sclerosis and Walking Impairment, sponsored by Adamas Pharmaceuticals, Inc.. Completed at 92 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-01-18.
Sponsored by Adamas Pharmaceuticals, Inc. (part of Supernus Pharmaceuticals, Inc.) · Phase 3, Interventional, and Treatment
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Among 1,192 studies in Multiple Sclerosis with a site in United States — 184 open to participants now, 259 under way, 23 of them phase 3. Multiple Sclerosis · United States.
Among the 1,192 studies in Multiple Sclerosis with a site in United States, this one is the 82nd largest by enrollment of the 879 interventional ones that give a count, is one of 62 that started in 2018, is one of 127 in phase 3, and was the 658th registered.
3,267 studies on the registry are indexed under Multiple Sclerosis; 662 are open to participants now.
Browse Multiple Sclerosis studies →184 of the 1,192 studies in Multiple Sclerosis with a site in United States are open now. Recruiting first, the newest first:
Sundance Biosciences, Inc. · Sites in United States
Ages 18–70
Genentech, Inc. · Sites in United States, Puerto Rico
Ages 18–65
The University of Texas Health Science Center, Houston · Sites in United States
Ages 18+
Washington University School of Medicine · Sites in United States
Ages 40–70
University of Texas at Austin · Sites in United States
Ages 18–80
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 430 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 211 (49%) stop at 75 or younger; 40 take children under 18; 96 take healthy volunteers.
This study: 18 Years to 70 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.
1,192 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 1 142 · Phase 2 191 · Phase 3 142 · Phase 4 82
First in 1976; this study’s year is marked. 62 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 424 is above the median of 50 across 2,203 interventional studies indexed under Multiple Sclerosis.
Median enrollment 50 across the 879 interventional studies, 100 across the 302 observational. Of the 818 that completed or were terminated, 332 (41%) have results posted.
This tab as a report to print or save as PDF → With an account.
376 of 1,192 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 4 studies filed under Multiple Sclerosis — fewer than ten, so there is no comparison to draw.
78 of the studies in Multiple Sclerosis with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05134441Phase 3Immunic AGStudy to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis | 2026-11 |
| NCT05877963Phase 3TG Therapeutics, Inc.Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab | 2027-01-21 |
| NCT06136728Phase 3MGH Institute of Health ProfessionsDalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis | 2027-05 |
| NCT06141473Phase 3SanofiEfficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis | 2027-05-06 |
| NCT07325292Phase 3SanofiNon-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis | 2027-07-15 |
Add all 78 to your calendar (.ics) → With an account.
Among the 1,192 studies in Multiple Sclerosis with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study assessed the long-term safety and tolerability of ADS-5102 in subjects with MS and walking impairment who had completed the double-blind, placebo-controlled study of ADS-5102 in subjects with MS (ADS-AMT-301).
This was a multicenter, open-label study of ADS-5102 (amantadine) extended-release capsules in subjects with MS and walking impairment who completed study drug treatment for 16 weeks and completed a Week 16 visit in Study ADS-AMT-MS301.
All enrolled subjects were to receive ADS-5102 at 137 mg for the first week, 205.5 mg for the second week, and 274 mg for the remainder of the 52-week open-label treatment period.
Subjects returned to the clinic for safety and efficacy assessments at Weeks 4, 24, and 52. In addition, a telephone visit for safety assessments was conducted at Week 2 and Week 38. Subjects who withdrew from the study prior to completion of the Week 52 visit had an early termination (ET) visit that included safety and efficacy assessments. Subjects who completed 52 weeks of open-label treatment had a final visit for post-treatment safety follow-up and efficacy assessment at Week 54.
All study visits and efficacy assessments were to be scheduled to occur at approximately the same time of day for each individual subject. Each subject's efficacy assessment was to be performed by the same clinical rater, if possible.
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.
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.
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.
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.
274 mg ADS-5102, administered once daily at bedtime for up to 52 weeks
Drug: ADS-5102, 274 mg
Oral capsules
Also known as: amantadine extended release
Number of Patients With Adverse Events
The incidence of treatment-emergent adverse events was used as the measure for long-term safety and tolerability of ADS-5102.
Time frame: Through study completion, an average of 1 year.
Timed 25-Foot Walk (Feet/Second) (Baseline Value)
The timed 25-foot walk is a measure of lower extremity function. The subject is directed to a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the subject walk back the same distance. The result is reported as speed (feet per second). Improvement is indicated by an increase in speed.
Time frame: Baseline
Timed 25-Foot Walk (Feet/Second) (Week 24 Value)
The timed 25-foot walk is a measure of lower extremity function. The subject is directed to a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the subject walk back the same distance. The result is reported as speed (feet per second). Improvement is indicated by an increase in speed.
Time frame: 24 weeks
Timed 25-Foot Walk (Feet/Second) (Week 52 Value)
The timed 25-foot walk is a measure of lower extremity function. The subject is directed to a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the subject walk back the same distance. The result is reported as speed (feet per second). Improvement is indicated by an increase in speed.
Time frame: 52 weeks
Timed up and go (Baseline Value)
The "timed up and go" is a measure of lower extremity strength, balance, and coordination. The subject stands up from a chair, walks 3 meters then turns around and walks back to the chair to sit down. The result is reported in seconds. Improvement is indicated by negative change scores.
Time frame: Baseline
Timed up and go (Week 24 Value)
The "timed up and go" is a measure of lower extremity strength, balance, and coordination. The subject stands up from a chair, walks 3 meters then turns around and walks back to the chair to sit down. The result is reported in seconds. Improvement is indicated by negative change scores.
Time frame: 24 weeks
Timed up and go (Week 52 Value)
The "timed up and go" is a measure of lower extremity strength, balance, and coordination. The subject stands up from a chair, walks 3 meters then turns around and walks back to the chair to sit down. The result is reported in seconds. Improvement is indicated by negative change scores.
Time frame: 52 weeks
2-Minute Walk Test (Baseline Value)
The 2-Minute Walk test is a measure of lower extremity function. The subject is instructed to walk as far as possible in 2 minutes, and the distance is measured in meters. Improvement is indicated by positive change scores.
Time frame: Baseline
2-Minute Walk Test (Week 24 Value)
The 2-Minute Walk test is a measure of lower extremity function. The subject is instructed to walk as far as possible in 2 minutes, and the distance is measured in meters. Improvement is indicated by positive change scores.
Time frame: 24 weeks
2-Minute Walk Test (Week 52 Value)
The 2-Minute Walk test is a measure of lower extremity function. The subject is instructed to walk as far as possible in 2 minutes, and the distance is measured in meters. Improvement is indicated by positive change scores.
Time frame: 52 weeks
| Milestone | Placebo/274 mg ADS-5102 | 137 mg ADS-5102/274 mg ADS-5102 | 274 mg ADS-5102/274 mg ADS-5102 |
|---|---|---|---|
| Started | 159 | 151 | 114 |
| Completed | 64 | 64 | 68 |
| Not completed | 95 | 87 | 46 |
| Withdrew: Adverse event | 56 | 53 | 28 |
| Withdrew: Withdrawal by subject | 22 | 24 | 13 |
| Withdrew: Lost to follow-up | 3 | 5 | 2 |
| Withdrew: Covid-19 pandemic | 4 | 3 | 0 |
| Withdrew: Non-compliance with study drug | 4 | 2 | 0 |
| Withdrew: Lack of efficacy | 3 | 0 | 1 |
| Withdrew: Death | 1 | 0 | 0 |
| Withdrew: Physician decision | 1 | 0 | 0 |
| Withdrew: Unstable medical condition | 1 | 0 | 0 |
| Withdrew: Medical history event | 0 | 0 | 1 |
| Withdrew: Other | 0 | 0 | 1 |
The incidence of treatment-emergent adverse events was used as the measure for long-term safety and tolerability of ADS-5102.
| Participants | Placebo/274 mg ADS-5102 | 137 mg ADS-5102/274 mg ADS-5102 | 274 mg ADS-5102/274 mg ADS-5102 |
|---|---|---|---|
| Number of Patients With Adverse Events | 122 | 116 | 86 |
The timed 25-foot walk is a measure of lower extremity function. The subject is directed to a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the subject walk back the same distance. The result is reported as speed (feet per second). Improvement is indicated by an increase in speed.
| feet/second | Placebo/274 mg ADS-5102 | 137 mg ADS-5102/274 mg ADS-5102 | 274 mg ADS-5102/274 mg ADS-5102 |
|---|---|---|---|
| Timed 25-Foot Walk (Feet/Second) (Baseline Value) | 2.43 ± 0.853 | 2.68 ± 0.840 | 2.66 ± 0.878 |
The timed 25-foot walk is a measure of lower extremity function. The subject is directed to a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the subject walk back the same distance. The result is reported as speed (feet per second). Improvement is indicated by an increase in speed.
| feet/second | Placebo/274 mg ADS-5102 | 137 mg ADS-5102/274 mg ADS-5102 | 274 mg ADS-5102/274 mg ADS-5102 |
|---|---|---|---|
| Timed 25-Foot Walk (Feet/Second) (Week 24 Value) | 2.50 ± 0.832 | 2.72 ± 0.969 | 2.71 ± 0.957 |
The timed 25-foot walk is a measure of lower extremity function. The subject is directed to a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the subject walk back the same distance. The result is reported as speed (feet per second). Improvement is indicated by an increase in speed.
| feet/second | Placebo/274 mg ADS-5102 | 137 mg ADS-5102/274 mg ADS-5102 | 274 mg ADS-5102/274 mg ADS-5102 |
|---|---|---|---|
| Timed 25-Foot Walk (Feet/Second) (Week 52 Value) | 2.35 ± 0.900 | 2.68 ± 1.055 | 2.65 ± 0.996 |
The "timed up and go" is a measure of lower extremity strength, balance, and coordination. The subject stands up from a chair, walks 3 meters then turns around and walks back to the chair to sit down. The result is reported in seconds. Improvement is indicated by negative change scores.
| seconds | Placebo/274 mg ADS-5102 | 137 mg ADS-5102/274 mg ADS-5102 | 274 mg ADS-5102/274 mg ADS-5102 |
|---|---|---|---|
| Timed up and go (Baseline Value) | 17.60 ± 8.516 | 16.89 ± 17.536 | 16.80 ± 10.652 |
The "timed up and go" is a measure of lower extremity strength, balance, and coordination. The subject stands up from a chair, walks 3 meters then turns around and walks back to the chair to sit down. The result is reported in seconds. Improvement is indicated by negative change scores.
| seconds | Placebo/274 mg ADS-5102 | 137 mg ADS-5102/274 mg ADS-5102 | 274 mg ADS-5102/274 mg ADS-5102 |
|---|---|---|---|
| Timed up and go (Week 24 Value) | 17.39 ± 9.466 | 15.36 ± 9.109 | 16.89 ± 11.649 |
The "timed up and go" is a measure of lower extremity strength, balance, and coordination. The subject stands up from a chair, walks 3 meters then turns around and walks back to the chair to sit down. The result is reported in seconds. Improvement is indicated by negative change scores.
| seconds | Placebo/274 mg ADS-5102 | 137 mg ADS-5102/274 mg ADS-5102 | 274 mg ADS-5102/274 mg ADS-5102 |
|---|---|---|---|
| Timed up and go (Week 52 Value) | 18.68 ± 11.710 | 15.92 ± 11.820 | 17.37 ± 12.311 |
The 2-Minute Walk test is a measure of lower extremity function. The subject is instructed to walk as far as possible in 2 minutes, and the distance is measured in meters. Improvement is indicated by positive change scores.
| meters | Placebo/274 mg ADS-5102 | 137 mg ADS-5102/274 mg ADS-5102 | 274 mg ADS-5102/274 mg ADS-5102 |
|---|---|---|---|
| 2-Minute Walk Test (Baseline Value) | 80.26 ± 31.899 | 89.99 ± 31.679 | 87.31 ± 31.351 |
The 2-Minute Walk test is a measure of lower extremity function. The subject is instructed to walk as far as possible in 2 minutes, and the distance is measured in meters. Improvement is indicated by positive change scores.
| meters | Placebo/274 mg ADS-5102 | 137 mg ADS-5102/274 mg ADS-5102 | 274 mg ADS-5102/274 mg ADS-5102 |
|---|---|---|---|
| 2-Minute Walk Test (Week 24 Value) | 81.48 ± 31.653 | 87.99 ± 34.195 | 92.03 ± 38.371 |
The 2-Minute Walk test is a measure of lower extremity function. The subject is instructed to walk as far as possible in 2 minutes, and the distance is measured in meters. Improvement is indicated by positive change scores.
| meters | Placebo/274 mg ADS-5102 | 137 mg ADS-5102/274 mg ADS-5102 | 274 mg ADS-5102/274 mg ADS-5102 |
|---|---|---|---|
| 2-Minute Walk Test (Week 52 Value) | 77.45 ± 34.147 | 89.18 ± 36.707 | 89.14 ± 37.295 |
Collected over Approximately 1 year.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo/274 mg ADS-5102 | 1/159 (0.6%) | 20/159 (12.6%) | 122/159 (76.7%) |
| 137 mg ADS-5102/274 mg ADS-5102 | 0/151 (0%) | 20/151 (13.2%) | 116/151 (76.8%) |
| 274 mg ADS-5102/274 mg ADS-5102 | 0/114 (0%) | 7/114 (6.1%) | 86/114 (75.4%) |
| Event | Placebo/274 mg ADS-5102 | 137 mg ADS-5102/274 mg ADS-5102 | 274 mg ADS-5102/274 mg ADS-5102 |
|---|---|---|---|
| Multiple sclerosis relapseNervous system disorders | 3/159 | 2/151 | 0/114 |
| CellulitisInfections and infestations | 3/159 | 1/151 | 0/114 |
| SeizureNervous system disorders | 0/159 | 2/151 | 0/114 |
| SyncopeNervous system disorders | 0/159 | 1/151 | 1/114 |
| Generalized tonic-clonic seizureNervous system disorders | 0/159 | 0/151 | 1/114 |
| Urinary tract infectionInfections and infestations | 1/159 | 1/151 | 1/114 |
| Atypical pneumoniaInfections and infestations | 0/159 | 0/151 | 1/114 |
| Bursitis infective staphylococcalInfections and infestations | 0/159 | 0/151 | 1/114 |
| DiarrhoeaGastrointestinal disorders | 1/159 | 0/151 | 1/114 |
| Femur fractureInjury, poisoning and procedural complications | 0/159 | 1/151 | 1/114 |
| Event | Placebo/274 mg ADS-5102 | 137 mg ADS-5102/274 mg ADS-5102 | 274 mg ADS-5102/274 mg ADS-5102 |
|---|---|---|---|
| Oedema peripheralGeneral disorders | 28/159 | 17/151 | 10/114 |
| FallInjury, poisoning and procedural complications | 14/159 | 16/151 | 17/114 |
| Urinary tract infectionInfections and infestations | 16/159 | 15/151 | 15/114 |
| Dry mouthGastrointestinal disorders | 13/159 | 18/151 | 2/114 |
| Livedo reticularisSkin and subcutaneous tissue disorders | 10/159 | 18/151 | 8/114 |
| ConstipationGastrointestinal disorders | 15/159 | 9/151 | 5/114 |
| Hallucination, visualPsychiatric disorders | 7/159 | 11/151 | 4/114 |
| Multiple sclerosis relapseNervous system disorders | 11/159 | 8/151 | 8/114 |
| InsomniaPsychiatric disorders | 5/159 | 10/151 | 5/114 |
| Peripheral swellingGeneral disorders | 9/159 | 4/151 | 2/114 |
| Age, Continuous(years) | Placebo/274 mg ADS-5102 | 137 mg ADS-5102/274 mg ADS-5102 | 274 mg ADS-5102/274 mg ADS-5102 | Total |
|---|---|---|---|---|
| Mean | 54.7 ± 9.80 | 54.8 ± 9.12 | 53.0 ± 9.40 | 54.3 ± 9.47 |
| Sex: Female, Male(Participants) | Placebo/274 mg ADS-5102 | 137 mg ADS-5102/274 mg ADS-5102 | 274 mg ADS-5102/274 mg ADS-5102 | Total |
|---|---|---|---|---|
| Female | 108 | 100 | 76 | 284 |
| Male | 51 | 51 | 38 | 140 |
| Race (NIH/OMB)(Participants) | Placebo/274 mg ADS-5102 | 137 mg ADS-5102/274 mg ADS-5102 | 274 mg ADS-5102/274 mg ADS-5102 | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 2 | 1 | 0 | 3 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 20 | 20 | 12 | 52 |
| White | 133 | 128 | 99 | 360 |
| More than one race | 2 | 0 | 0 | 2 |
| Unknown or Not Reported | 2 | 2 | 3 | 7 |
| Baseline T25FW(Participants) | Placebo/274 mg ADS-5102 | 137 mg ADS-5102/274 mg ADS-5102 | 274 mg ADS-5102/274 mg ADS-5102 | Total |
|---|---|---|---|---|
| <Median of enrolled population (9.4 seconds) | 63 | 85 | 58 | 206 |
| >Median of enrolled population (9.4 seconds) | 96 | 66 | 55 | 217 |
| Missing | 0 | 0 | 1 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jul 2018 to primary completion in Nov 2020, 27 months.
Results were first posted in Jan 2022, 1 year 2 months after primary completion.
Of 71 industry-sponsored phase 3 interventional studies under Multiple Sclerosis, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 54. This study's 27 months is below that.
Counting every sponsor, half of 96 studies reached it within 42 months; a quarter within 26 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Adamas Pharmaceuticals, Inc. →