Multiple SclerosisPhase 3NCT03567057

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

A Phase 3 study testing ADS-5102, 274 mg in people with Multiple Sclerosis and Walking Impairment, run by Adamas Pharmaceuticals, Inc. at 92 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 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). Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Multiple Sclerosis, Walking Impairment
What is being tested?: ADS-5102, 274 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 424 participants
Where: 92 sitesin 2 countries
Study dates: 18 Jul 2018to 18 Apr 2021
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
Successful completion of a prior double blind study of ADS-5102 in patients with MS walking impairment.

Who cannot join

Based on the judgment of the investigator or Medical Monitor, participation in the study would jeopardize the safety of the subject.
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 baseline 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.
Anticipated treatment with any amantadine formulation other than ADS-5102
Planned participation in another interventional clinical trial

Trial locations and contacts

92 sites in 2 countries.

Country

City, postcode or hospital

92 sites in 2 countries

United States82 sites

Adamas Clinical Site
Albuquerque, New Mexico, 87106
Adamas Clinical Site
Amherst, New York, 14226
Adamas Clinical Site
Atlanta, Georgia, 30309
Adamas Clinical Site
Aurora, Colorado, 80045
Adamas Clinical Site
Burlington, Massachusetts, 01805
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, 28204
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, 800209
Adamas Clinical Site
Detroit, Michigan, 42801
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, 66103
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, 89106
Adamas Clinical Site
Lenexa, Kansas, 66214
Adamas Clinical Site
Lincoln, Nebraska, 68506
Adamas Clinical Site
Long Beach, California, 90806
Adamas Clinical Site
Lubbock, Texas, 79410
Adamas Clinical Site
Maitland, Florida, 32751
Adamas Clinical Site
Miami, Florida, 33136
Adamas Clinical Site
Miami, Florida, 33176
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
Omaha, Nebraska, 68105
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, 85018
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, 97213
Adamas Clinical Site
Raleigh, North Carolina, 27607
Adamas Clinical Site
Rochester, New York, 14642
Adamas Clinical Site
Rock Hill, South Carolina, 29732
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
Seattle, Washington, 98122
Adamas Clinical Site
Seattle, Washington, 98191
Adamas Clinical Site
Spartanburg, South Carolina, 29307
Adamas Clinical Site
St Louis, Missouri, 63110
Adamas Clinical Site
St. Petersburg, Florida, 33713
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
Adamas Clinical Site
Worcester, Massachusetts, 01655

Other trials in United States

Canada10 sites

Adamas Clinical Site
Burnaby, Brithis Columbia, V5G 2X6
Adamas Clinical Site
Edmonton, Alberta, T6G 2G3
Adamas Clinical Site
Greenfield Park, Quebec, J4V 2J2
Adamas Clinical Site
Hamilton, Ontario, L8L 2X2
Adamas Clinical Site
Lethbridge, Alberta, T1J 0N9
Adamas Clinical Site
London, Ontario, N6A 5A5
Adamas Clinical Site
Montreal, Quebec, H3A 2B4
Adamas Clinical Site
Ottawa, Ontario, K1H 8L6
Adamas Clinical Site
Québec, Quebec, G1J 1Z4
Adamas Clinical Site
Vancouver, British Columbia, V6T 2B5

Other trials in Canada

About this study

Official title: A Multicenter, Open-Label Safety and Efficacy Study of ADS-5102 Amantadine Extended Release Capsules in Patients With Multiple Sclerosis and Walking Impairment

Read the detailed description

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.

Conditions: Multiple Sclerosis, Walking Impairment
Being tested: ADS-5102, 274 mg
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, 274 mgDrug
Also called amantadine extended release
Oral capsules

Study groups in NCT03567057
Study group	Role	What they receive
ADS-5102, 274 mg	Experimental	274 mg ADS-5102, administered once daily at bedtime for up to 52 weeks Receives: Drug: ADS-5102, 274 mg

What is being measured

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

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.
Measured: Through study completion, an average of 1 year.

Secondary outcomes (9)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 52 weeks

Timeline

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

18 Jul 201818 Apr 2021

First posted25 Jun 2018
Study start18 Jul 2018
Primary completion17 Nov 2020
Study completion18 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Multiple SclerosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 424 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03567057
Sponsor's protocol ID: ADS-AMT-MS303
Status last verified: Jan 2022
First submitted: 22 May 2018
Last updated: 18 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open-Label Safety and Efficacy Study of ADS-5102 Amantadine Extended Release Capsules in Patients With Multiple Sclerosis and Walking Impairment
ClinicalTrials.gov ID: NCT03567057
Acronym / sponsor ID: ADS-AMT-MS303
Conditions: Multiple Sclerosis, Walking Impairment
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 424 participants (actual)
Lead sponsor: Adamas Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 18 Jul 2018 (actual)
Primary completion: 17 Nov 2020 (actual)
Study completion: 18 Apr 2021 (actual)
First posted: 25 Jun 2018 (actual)
Results: Posted 18 Jan 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ADS-5102, 274 mg	Experimental	Drug: ADS-5102, 274 mg274 mg ADS-5102, administered once daily at bedtime for up to 52 weeks

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Signed a current IRB-approved informed consent form
Successful completion of a prior double blind study of ADS-5102 in patients with MS walking impairment.

Key exclusion criteria (5 listed)

Based on the judgment of the investigator or Medical Monitor, participation in the study would jeopardize the safety of the subject.
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 baseline 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.
Anticipated treatment with any amantadine formulation other than ADS-5102
Planned participation in another interventional clinical trial

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ADS-5102, 274 mgAlso: amantadine extended releaseOral capsules	Drug	ADS-5102, 274 mg

Primary outcome

Number of Patients With Adverse Events
Time frame: Through study completion, an average of 1 year.
The incidence of treatment-emergent adverse events was used as the measure for long-term safety and tolerability of ADS-5102.

9 secondary outcomes

Timed 25-Foot Walk (Feet/Second) (Baseline Value)
Time frame: Baseline
Timed 25-Foot Walk (Feet/Second) (Week 24 Value)
Time frame: 24 weeks
Timed 25-Foot Walk (Feet/Second) (Week 52 Value)
Time frame: 52 weeks
Timed up and go (Baseline Value)
Time frame: Baseline
Timed up and go (Week 24 Value)
Time frame: 24 weeks
Timed up and go (Week 52 Value)
Time frame: 52 weeks
2-Minute Walk Test (Baseline Value)
Time frame: Baseline
2-Minute Walk Test (Week 24 Value)
Time frame: 24 weeks
2-Minute Walk Test (Week 52 Value)
Time frame: 52 weeks

Results and safety

Results posted to the registry on 18 Jan 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo/274 mg ADS-5102	159	64
137 mg ADS-5102/274 mg ADS-5102	151	64
274 mg ADS-5102/274 mg ADS-5102	114	68

Primary outcome: Number of Patients With Adverse Events

Time frame: Through study completion, an average of 1 year.. Count of participants. Unit: Participants

Measure	Placebo/274 mg ADS-5102 n = 159	137 mg ADS-5102/274 mg ADS-5102 n = 151	274 mg ADS-5102/274 mg ADS-5102 n = 114
Value	122	116	86

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Approximately 1 year.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo/274 mg ADS-5102	20 of 159 (12.6%)	122 of 159 (76.7%)	1 of 159
137 mg ADS-5102/274 mg ADS-5102	20 of 151 (13.2%)	116 of 151 (76.8%)	0 of 151
274 mg ADS-5102/274 mg ADS-5102	7 of 114 (6.1%)	86 of 114 (75.4%)	0 of 114

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials Chief Medical Officer, MD study director

Adamas Pharmaceuticals, Inc.

92 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ADS-5102, 274 mg in people with Multiple Sclerosis and Walking Impairment, run by Adamas Pharmaceuticals, Inc. at 92 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 2 inclusion and 5 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 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 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 18 Jan 2022). 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?

Number of Patients With Adverse Events (time frame: Through study completion, an average of 1 year.). 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 NCT03567057.

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 18 Jan 2022.