A Phase 3 interventional study of ADS-5102, 137 mg and ADS-5102, 274 mg in Walking Impairment and Multiple Sclerosis, sponsored by Adamas Pharmaceuticals, Inc.. Completed at 84 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-12-21.
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 69th 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 641st registered.
3,269 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 558 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 efficacy and safety of ADS-5102 (at daily doses of 137 mg or 274 mg) compared with placebo in MS patients with walking impairment.
This was a multicenter, 3-arm, randomized, placebo-controlled, double-blind, parallel-group study of ADS-5102 (amantadine) extended release capsules in MS subjects with walking impairment. The study consisted of a screening period (up to 3 weeks), a single-blind placebo run-in period (4 weeks; during which subjects were blinded to treatment), and a double-blind treatment period (12 weeks).
For at least 30 days prior to screening, all subjects were to have received a stable regimen of MS medications, both disease-modifying and symptomatic; these medications were to continue at the same doses and regimens for the duration of the subjects' participation in the study, to the extent compatible with good neurological care. Subjects were not to have used amantadine, dalfampridine, or any 4 aminopyridine or 2,4 diaminopyridine preparation within 30 days prior to screening.
Consented subjects who completed the screening period were to undergo a 4-week single-blind placebo run-in period during which they received placebo as 2 capsules once daily at bedtime.
Subjects who completed the single-blind placebo run-in period and continued to meet study eligibility criteria were randomized with equal probability to 1 of 3 treatment groups: placebo or ADS-5102 at a final dose of 137 mg/day or 274 mg/day. Study drugs were administered as 2 capsules once daily at bedtime.
Subjects were to return to the clinic for safety and efficacy assessments at Week 0 and Week 2 prior to randomization and at Weeks 4 (randomization and baseline visit), 6 (only safety), 8, 12, and 16 after randomization. In addition, telephone visits for safety assessments were conducted at Weeks 5 and 7. Subjects who withdrew from the study before Week 16 were to have an early termination visit that included safety follow-up and efficacy assessments, as appropriate.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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, administered once daily at bedtime from Week 4 through Week 16
Drug: ADS-5102, 137 mg
ADS-5102, administered once daily at bedtime from Week 4 through Week 16
Drug: ADS-5102, 274 mg
placebo, administered once daily at bedtime from Week 4 through Week 16
Other: Placebo
Oral capsules
Also known as: ADS-5102, amantadine extended release
Oral capsules
Also known as: ADS-5102, amantadine extended release
Oral capsules
Timed 25 Foot Walk (T25FW, Feet/Second): the Proportion of Subjects With a ≥ 20% Increase in Walking Speed (Measured by T25FW) From Baseline at Week 16 (Responder Analysis)
The T25FW 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. For this outcome measure, the result is reported as speed (feet per second). Improvement is indicated by an increase in speed.
Time frame: 16 weeks
Timed 25 Foot Walk: Change From Baseline at Week 16
The T25FW 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. For this outcome measure, the result is reported as or speed (feet per second). Improvement is indicated by an increase in speed.
Time frame: 16 weeks
Timed Up and Go (TUG): Change From Baseline at Week 16
The TUG 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: 16 weeks
2-Minute Walk Test (2MWT): Change From Baseline at Week 16
The 2MWT 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: 16 weeks
| Milestone | ADS-5102 137 mg | ADS-5102 274 mg | Placebo |
|---|---|---|---|
| Started | 187 | 185 | 186 |
| Completed | 165 | 132 | 174 |
| Not completed | 22 | 53 | 12 |
| Withdrew: Adverse event | 15 | 40 | 7 |
| Withdrew: Withdrawal by subject | 4 | 10 | 3 |
| Withdrew: Lost to follow-up | 1 | 0 | 2 |
| Withdrew: Protocol violation | 1 | 1 | 0 |
| Withdrew: Physician decision | 0 | 1 | 0 |
| Withdrew: Could not return to clinic | 1 | 0 | 0 |
| Withdrew: Withdrawn per physician | 0 | 1 | 0 |
The T25FW 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. For this outcome measure, the result is reported as speed (feet per second). Improvement is indicated by an increase in speed.
| proportion of responders | ADS-5102 137 mg | ADS-5102 274 mg | Placebo |
|---|---|---|---|
| Timed 25 Foot Walk (T25FW, Feet/Second): the Proportion of Subjects With a ≥ 20% Increase in Walking Speed (Measured by T25FW) From Baseline at Week 16 (Responder Analysis) | 0.176 | 0.211 | 0.113 |
The T25FW 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. For this outcome measure, the result is reported as or speed (feet per second). Improvement is indicated by an increase in speed.
| feet/second | ADS-5102 137 mg | ADS-5102 274 mg | Placebo |
|---|---|---|---|
| Timed 25 Foot Walk: Change From Baseline at Week 16 | 0.19 ± 0.034 | 0.19 ± 0.034 | 0.07 ± 0.033 |
The TUG 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 | ADS-5102 137 mg | ADS-5102 274 mg | Placebo |
|---|---|---|---|
| Timed Up and Go (TUG): Change From Baseline at Week 16 | -1.35 ± 0.384 | -0.60 ± 0.415 | -0.56 ± 0.377 |
The 2MWT 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 | ADS-5102 137 mg | ADS-5102 274 mg | Placebo |
|---|---|---|---|
| 2-Minute Walk Test (2MWT): Change From Baseline at Week 16 | 6.306 ± 1.2422 | 5.692 ± 1.3537 | 2.163 ± 1.2158 |
Collected over 18 weeks. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ADS-5102 137 mg | 0/187 (0%) | 5/187 (2.7%) | 105/187 (56.1%) |
| ADS-5102 274 mg | 0/185 (0%) | 11/185 (5.9%) | 140/185 (75.7%) |
| Placebo | 0/186 (0%) | 1/186 (0.5%) | 90/186 (48.4%) |
| Event | ADS-5102 137 mg | ADS-5102 274 mg | Placebo |
|---|---|---|---|
| Multiple sclerosis relapseNervous system disorders | 0/187 | 2/185 | 0/186 |
| AppendicitisInfections and infestations | 1/187 | 1/185 | 0/186 |
| Viral upper respiratory tract infectionInfections and infestations | 0/187 | 1/185 | 0/186 |
| Facial spasmNervous system disorders | 0/187 | 1/185 | 0/186 |
| Musculoskeletal stiffnessMusculoskeletal and connective tissue disorders | 0/187 | 1/185 | 0/186 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 0/187 | 1/185 | 0/186 |
| Hallucinations, mixedPsychiatric disorders | 0/187 | 1/185 | 0/186 |
| Suicide attemptPsychiatric disorders | 0/187 | 1/185 | 0/186 |
| Vision blurredEye disorders | 0/187 | 1/185 | 0/186 |
| IleusGastrointestinal disorders | 0/187 | 1/185 | 0/186 |
| Event | ADS-5102 137 mg | ADS-5102 274 mg | Placebo |
|---|---|---|---|
| Oedema peripheralGeneral disorders | 8/187 | 29/185 | 1/186 |
| Dry mouthGastrointestinal disorders | 6/187 | 25/185 | 2/186 |
| Urinary tract infectionInfections and infestations | 7/187 | 16/185 | 19/186 |
| FallInjury, poisoning and procedural complications | 8/187 | 16/185 | 13/186 |
| ConstipationGastrointestinal disorders | 8/187 | 15/185 | 1/186 |
| InsomniaPsychiatric disorders | 3/187 | 13/185 | 0/186 |
| DizzinessNervous system disorders | 5/187 | 8/185 | 4/186 |
| TremorNervous system disorders | 2/187 | 8/185 | 1/186 |
| FatigueGeneral disorders | 6/187 | 8/185 | 5/186 |
| Vision blurredEye disorders | 2/187 | 8/185 | 1/186 |
| Age, Continuous(years) | ADS-5102 137 mg | ADS-5102 274 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 54.7 ± 9.13 | 54.0 ± 9.27 | 54.5 ± 9.75 | 54.4 ± 9.37 |
| Sex: Female, Male(Participants) | ADS-5102 137 mg | ADS-5102 274 mg | Placebo | Total |
|---|---|---|---|---|
| Female | 125 | 124 | 128 | 377 |
| Male | 62 | 61 | 58 | 181 |
| Race (NIH/OMB)(Participants) | ADS-5102 137 mg | ADS-5102 274 mg | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 2 | 3 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 24 | 21 | 23 | 68 |
| White | 158 | 160 | 155 | 473 |
| More than one race | 1 | 0 | 3 | 4 |
| Unknown or Not Reported | 3 | 4 | 3 | 10 |
| Time since diagnosis of multiple sclerosis(years) | ADS-5102 137 mg | ADS-5102 274 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 15.99 ± 9.862 | 15.97 ± 9.655 | 15.85 ± 9.478 | 15.94 ± 9.649 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2018 to primary completion in Dec 2019, 20 months.
Results were first posted in Dec 2021, 2 years 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 20 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 Dec 2021. You cannot join it, but the record below documents what was studied.
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Adamas Pharmaceuticals, Inc. →