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Walking ImpairmentPhase 3NCT03436199

Safety and Efficacy of ADS-5102 in Multiple Sclerosis Patients With Walking Impairment

A Phase 3 study testing ADS-5102, 137 mg and ADS-5102, 274 mg in people with Walking Impairment and Multiple Sclerosis, run by Adamas Pharmaceuticals, Inc. at 84 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Walking Impairment, Multiple Sclerosis
What is being tested?
ADS-5102, 137 mg and ADS-5102, 274 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
558 participants
Where
84 sitesin 2 countries
Study dates
29 Mar 2018to 10 Dec 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed a current IRB-approved informed consent form
  • Male or female subjects between 18 and 70 years of age, inclusive, at the time of Screening
  • Confirmed diagnosis of MS according to the 2017 McDonald criteria
  • Current medication regimen must be stable for at least 30 days prior to screening, and subject must be willing to continue the same dosing regimen for the duration of study participation
  • Maximum Expanded Disability Status Scale (EDSS) score during screening of 6.5
  • Stable physical activity level (inclusive of prescribed physical therapy) for at least 30 days prior to screening and willing to continue without change for the duration of study participation
  • A score on each of two completed screening T25FW tests between 8 and 45 seconds, inclusive

Who cannot join

  • Documented inability to tolerate amantadine
  • Clinically significant MS relapse with onset less than 30 days prior to screening
  • Receipt of dalfampridine (or any 4-aminopyridine or 2,4-diaminopyridine preparation) or amantadine within 30 days prior to screening
  • History of seizures within 3 years prior to screening
  • History of hallucinations (visual, auditory, or any other type) within 3 years prior to screening
  • History of bipolar disorder, schizophrenia, or psychosis, regardless of treatment
Show all 12Show fewer
  • For subjects with a history of major depressive disorder, the presence of active depressive symptoms that, in the opinion of the investigator, would affect the subject's ability to complete study assessments, or which would not be in the subject's best interest to participate in the study
  • Presence of orthostatic hypotension at screening: a decrease in systolic blood pressure (at least 20 mm Hg) or diastolic blood pressure (at least 10 mm Hg) within 3 minutes of the subject standing up, compared to pressures obtained while sitting
  • If female, is pregnant or lactating
  • If a sexually active female, is not surgically sterile or at least 2 years post-menopausal, or does not agree to utilize a highly effective hormonal method of contraception (an IUD, or vasectomized male partner is also acceptable), in combination with a barrier method, from screening through at least 4 weeks after the completion of study treatment. If a sexually active male, does not agree to utilize condoms from screening through at least 4 weeks after the completion of study treatment.
  • Treatment with an investigational drug or device within 30 days prior to screening
  • Treatment with an investigational biologic within 6 months or 5 half-lives, whichever is longer, prior to screening

Trial locations and contacts

84 sites in 2 countries.

84 sites in 2 countries

United States78 sites

  • Adamas Clinical Site

    Albuquerque, New Mexico, 87131

  • Adamas Clinical Site

    Amherst, New York, 14226

  • Adamas Clinical Site

    Atlanta, Georgia, 30309

  • Adamas Clinical Site

    Aurora, Colorado, 80045

  • Adamas Clinical Site

    Carlsbad, California, 92011

  • Adamas Clinical Site

    Centerville, Ohio, 45459

  • Adamas Clinical Site

    Charleston, South Carolina, 29406

  • Adamas Clinical Site

    Charlotte, North Carolina, 28207

  • Adamas Clinical Site

    Cleveland, Ohio, 44195

  • Adamas Clinical Site

    Colorado Springs, Colorado, 80907

  • Adamas Clinical Site

    Columbus, Ohio, 43214

  • Adamas Clinical Site

    Cordova, Tennessee, 38018

  • Adamas Clinical Site

    Cullman, Alabama, 35058

  • Adamas Clinical Site

    Denver, Colorado, 80209

  • Admas Clinical Site

    Detroit, Michigan, 48201

  • Adamas Clinical Site

    Fairfield, Connecticut, 06824

  • Adamas Clinical Site

    Farmington Hills, Michigan, 48334

  • Adamas Clinical Site

    Fort Collins, Colorado, 80528

  • Adamas Clinical Site

    Foxborough, Massachusetts, 02035

  • Adamas Clinical Site

    Franklin, Tennessee, 37064

  • Adamas Clinical Site

    Fresno, California, 93710

  • Adamas Clinical Site

    Fullerton, California, 92835

  • Adamas Clinical Site

    Golden Valley, Minnesota, 55422

  • Adamas Clinical Site

    Great Falls, Montana, 59405

  • Adamas Clinical Site

    Greer, South Carolina, 29650

  • Adamas Clinical Site

    Houston, Texas, 77030

  • Adamas Clinical Site

    Houston, Texas, 77074

  • Adamas Clinical Site

    Indianapolis, Indiana, 46256

  • Adamas Clinical Site

    Johnson City, Tennessee, 37604

  • Adamas Clinical Site

    Kansas City, Kansas, 66160

  • Adamas Clinical Site

    Kansas City, Missouri, 64111

  • Adamas Clinical Site

    Kirkland, Washington, 98034

  • Adamas Clinical Site

    Lake Success, New York, 11042

  • Adamas Clinical Site

    Las Vegas, Nevada, 89016

  • Adamas Clinical Site

    Lenexa, Kansas, 66214

  • Adamas Clinical Site

    Lexington, Massachusetts, 02421

  • Adamas Clinical Site

    Lincoln, Nebraska, 68506

  • Adamas Clinical Site

    Long Beach, California, 90806

  • Adamas Clinical Site

    Maitland, Florida, 32751

  • Adamas Clinical Site

    Miami, Florida, 33136

  • Adamas Clinical Site

    Milwaukee, Wisconsin, 53215

  • Adamas Clinical Site

    Naples, Florida, 34105

  • Adamas Clinical Site

    New London, Connecticut, 06320

  • Adamas Clinical Site

    New York, New York, 10029

  • Adamas Clinical Site

    Newport Beach, California, 92663

  • Adamas Clinical Site

    Newport News, Virginia, 23601

  • Adamas Clinical Site

    Norfolk, Virginia, 23502

  • Adamas Clinical Site

    Northbrook, Illinois, 60062

  • Adamas Clinical Site

    Oklahoma City, Oklahoma, 73104

  • Adamas Clinical Site

    Old Point Station, South Carolina, 29707

  • Adamas Clinical Site

    Omaha, Nebraska, 68198

  • Adamas Clinical Site

    Orlando, Florida, 32806

  • Adamas Clinical Site

    Ormond Beach, Florida, 32174

  • Adamas Clinical Site

    Overland Park, Kansas, 66212

  • Adamas Clinical Site

    Palm Coast, Florida, 32164

  • Adamas Clinical Site

    Patchogue, New York, 11772

  • Adamas Clinical Site

    Philadelphia, Pennsylvania, 19140

  • Adamas Clinical Site

    Phoenix, Arizona, 85032

  • Adamas Clinical Site

    Plainview, New York, 11803

  • Adamas Clinical Site

    Port Charlotte, Florida, 33952

  • Adamas Clinical Site

    Portland, Oregon, 97225

  • Adamas Clinical Site

    Raleigh, North Carolina, 27607

  • Adamas Clinical Site

    Rochester, New York, 14642

  • Adamas Clinical Site

    Round Rock, Texas, 78681

  • Adamas Clinical Site

    Sacramento, California, 95817

  • Adamas Clinical Site

    Salt Lake City, Utah, 84103

  • Adamas Clinical Site

    Sarasota, Florida, 34233

  • Adamas Clinical Site

    Savannah, Georgia, 31406

  • Adamas Clinical Site

    Scottsdale, Arizona, 85251

  • Adamas Clinical Site

    Seattle, Washington, 98101

  • Adamas Clinical Site

    Seattle, Washington, 98122

  • Adamas Clinical Site

    Spartanburg, South Carolina, 29307

  • Adamas Clinical Site

    St Louis, Missouri, 63110

  • Adamas Clinical Site

    Staten Island, New York, 10306

  • Adamas Clinical Site

    Tampa, Florida, 33609

  • Adamas Clinical Site

    Tucson, Arizona, 85704

  • Adamas Clinical Site

    Vero Beach, Florida, 32960

  • Adamas Clinical Site

    Washington D.C., District of Columbia, 20007

Other trials in United States

Canada6 sites

  • Adamas Clinical Site

    Burnaby, British Columbia, V5G 2X6

  • Adamas Clinical Site

    Edmonton, Alberta, T6R 2B7

  • Adamas Clinical Site

    Greenfield Park, Quebec, J4V 2J2

  • Adamas Clinical Site

    Lethbridge, Alberta, T1J 0N9

  • Adamas Clinical Site

    Montreal, Quebec, H3A 2B4

  • Adamas Clinical Site

    Québec, Quebec, G1J 1Z4

Other trials in Canada

About this study

Official title: A 3-arm, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of ADS-5102 Amantadine Extended Release Capsules in Multiple Sclerosis Patients With Walking Impairment

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.

Read the detailed description

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.

Being tested
ADS-5102, 137 mg, ADS-5102, 274 mg, Placebo
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ADS-5102, 137 mgDrug

    Also called ADS-5102, amantadine extended release

    Oral capsules

  • ADS-5102, 274 mgDrug

    Also called ADS-5102, amantadine extended release

    Oral capsules

  • PlaceboOther

    Oral capsules

Study groups in NCT03436199
Study groupRoleWhat they receive
ADS-5102, 137 mgExperimentalADS-5102, administered once daily at bedtime from Week 4 through Week 16
Receives: Drug: ADS-5102, 137 mg
ADS-5102, 274 mgExperimentalADS-5102, administered once daily at bedtime from Week 4 through Week 16
Receives: Drug: ADS-5102, 274 mg
PlaceboOtherplacebo, administered once daily at bedtime from Week 4 through Week 16
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 16 weeks

Secondary outcomes (3)

  1. 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.

    Measured: 16 weeks

  2. 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.

    Measured: 16 weeks

  3. 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.

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2018
  2. Study start29 Mar 2018
  3. Primary completion10 Dec 2019
  4. Study completion10 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
558 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03436199
Sponsor's protocol ID
ADS-AMT-MS301
Status last verified
Dec 2021
First submitted
12 Feb 2018
Last updated
21 Dec 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ADS-5102, 137 mg and ADS-5102, 274 mg in people with Walking Impairment and Multiple Sclerosis, run by Adamas Pharmaceuticals, Inc. at 84 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03436199.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.

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