Walking ImpairmentPhase 2NCT02471222

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

A Phase 2 study testing ADS-5102 in people with Walking Impairment and Multiple Sclerosis, run by Adamas Pharmaceuticals, Inc. at 15 sites in United States.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Walking Impairment, Multiple Sclerosis
What is being tested?: ADS-5102
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 15 sitesUnited States
Study dates: May 2015to Jun 2016
Phase: Phase 2
Are there results?: None posted in the registry

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;
Confirmed diagnosis of Multiple Sclerosis according to the 2010 Revised McDonald criteria;
On a stable regimen of medications taken specifically to treat MS for at least 30 days prior to screening, and willing to continue the same doses and regimens for the duration of study participation;
Stable physical activity level for at least 30 days prior to screening and willing to continue without change for the duration of study participation;
Maximum EDSS score during screening of 6.5;

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Sufficient ambulatory ability to complete two trials of the Timed 25 Foot Walk (T25FW) at the screening visit;
A score on each completed screening T25FW test between 8 and 45 seconds, inclusive;
Any other current and allowed prescription/non-prescription medications and/or nutritional supplements taken regularly must have been at a stable dose and regimen for at least 30 days prior to screening, and subject must be willing to continue the same doses and regimens during study participation;
If taking an antidepressant, must be on a stable dose for at least 60 days prior to screening.

Who cannot join

History of seizures within 2 years prior to screening;
Clinically significant MS relapse with onset less than 30 days prior to screening;
Presence of vertigo or other vestibular dysfunction that might compromise ability to safely perform the T25FW;
Received physical therapy within 30 days prior to screening;
Received systemic steroids within 30 days prior to screening;
Received dalfampridine, methylphenidate, modafinil, armodafinil, amantadine, and/or any product containing amphetamines, or any treatment specifically for fatigue or to improve walking within 30 days prior to screening;

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Received any botulinum toxin containing product used as antispasmodic agent within 3 months prior to screening;
History of clinically significant hallucinations due to an MS medication or other/unknown cause, within 2 years prior to screening;
History of Bipolar Disorder or Psychosis, regardless of treatment;
Presence of cognitive impairment sufficient, in the opinion of the investigator, to 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;
History of stroke or TIA within 2 years prior to screening;
History of cancer within 5 years;
Presence of untreated angle closure glaucoma;
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;
Treatment with an investigational drug or device within 30 days prior to screening;
Treatment with an investigational biologic within 6 months prior to screening;
Current participation in another clinical trial;
Planned elective surgery during study participation.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Study site
Albuquerque, New Mexico, 87131
Study site
Atlanta, Georgia, 30309
Study site
Aurora, Colorado, 80045
Study site
Cleveland, Ohio, 44195
Study site
Dallas, Texas, 75214
Study site
Franklin, Tennessee, 37064
Study site
Kirkland, Washington, 11772
Study site
Lincoln, Nebraska, 68506
Study site
Northbrook, Illinois, 60062
Study site
Oklahoma City, Oklahoma, 73104
Study site
Patchogue, New York, 11772
Study site
Phoenix, Arizona, 85018
Study site
Raleigh, North Carolina, 27607
Study site
Rochester, Minnesota, 55905
Study site
Sarasota, Florida, 34239

Other trials in United States

About this study

Official title: Safety and Efficacy of ADS-5102 (Amantadine HCl) Extended Release Capsules in Patients With Multiple Sclerosis and Walking Impairment

This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, dosed once daily at bedtime for the treatment of walking impairment in MS. ADS-5102 is designed to be administered once daily at bed time, ADS-5102 achieves higher plasma amantadine concentrations in the early morning, sustained throughout the afternoon, and lower concentrations in the evening when patients are sleeping. ADS-5102 is designed to deliver its primary treatment effect during the day, and potentially reduce the adverse events of immediate-release amantadine when the patient is asleep.

Conditions: Walking Impairment, Multiple Sclerosis
Being tested: ADS-5102, 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-5102Drug
Also called amantadine HCl extended release
Oral capsules to be administered once daily at bedtime for 4 weeks
PlaceboOther
Oral capsules to be administered once daily at bedtime for 4 weeks

Study groups in NCT02471222
Study group	Role	What they receive
ADS-5102 (amantadine HCl extended release)	Experimental	Not described Receives: Drug: ADS-5102
Placebo	Placebo comparator	Not described Receives: Other: Placebo

What is being measured

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

Safety of ADS-5102 assessed by adverse events, safety-related study drug discontinuations, vital signs, and safety laboratory test
Measured: Up to 4 weeks

Secondary outcomes (4)

Timed 25 Foot Walk
Measured: Up to 4 weeks
Timed Up and go
Measured: Up to 4 weeks
2 Minute Walk Test
Measured: Up to 4 weeks
MS Walking Scale-12
Measured: Up to 4 weeks

Timeline

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

May 2015Jun 2016

First posted15 Jun 2015 (estimated)
Study startMay 2015
Primary completionJun 2016
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Walking ImpairmentStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02471222
Sponsor's protocol ID: ADS-AMT-MS201
Status last verified: Aug 2017
First submitted: 11 Jun 2015
Last updated: 8 Aug 2017
Results posted: No
Data monitoring committee: 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

Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Rural Veteran and Care Partner Walking Program
Mild Cognitive Impairment (MCI)
Not yet recruiting
High-Velocity Resistance Training for Brain Blood Flow and Cognitive Function in Older Adults
At Risk for AD-dementia, With Subjective Cognitive Decline, At Risk for Cognitive Decline
Enrolling by invitation
FES: Effect on Walking in the Real World and Participation in Daily Life in People With Multiple Sclerosis.
Multiple Sclerosis

All Walking Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of ADS-5102 (Amantadine HCl) Extended Release Capsules in Patients With Multiple Sclerosis and Walking Impairment
ClinicalTrials.gov ID: NCT02471222
Acronym / sponsor ID: ADS-AMT-MS201
Conditions: Walking Impairment, Multiple Sclerosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Adamas Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: May 2015
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 15 Jun 2015 (estimated)
Results: Not posted in the source record

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
ADS-5102 (amantadine HCl extended release)	Experimental	Drug: ADS-5102
Placebo	Placebo comparator	Other: Placebo

Who may qualify

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

Key inclusion criteria (10 listed)

Signed a current IRB-approved informed consent form;
Male or female subjects between 18 and 70 years of age, inclusive;
Confirmed diagnosis of Multiple Sclerosis according to the 2010 Revised McDonald criteria;
On a stable regimen of medications taken specifically to treat MS for at least 30 days prior to screening, and willing to continue the same doses and regimens for the duration of study participation;
Stable physical activity level for at least 30 days prior to screening and willing to continue without change for the duration of study participation;

Key exclusion criteria (19 listed)

History of seizures within 2 years prior to screening;
Clinically significant MS relapse with onset less than 30 days prior to screening;
Presence of vertigo or other vestibular dysfunction that might compromise ability to safely perform the T25FW;
Received physical therapy within 30 days prior to screening;
Received systemic steroids within 30 days prior to screening;

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-5102Also: amantadine HCl extended releaseOral capsules to be administered once daily at bedtime for 4 weeks	Drug	ADS-5102 (amantadine HCl extended release)
PlaceboOral capsules to be administered once daily at bedtime for 4 weeks	Other	Placebo

Primary outcome

Safety of ADS-5102 assessed by adverse events, safety-related study drug discontinuations, vital signs, and safety laboratory test
Time frame: Up to 4 weeks

4 secondary outcomes

Timed 25 Foot Walk
Time frame: Up to 4 weeks
Timed Up and go
Time frame: Up to 4 weeks
2 Minute Walk Test
Time frame: Up to 4 weeks
MS Walking Scale-12
Time frame: Up to 4 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.

Related trials for Walking Impairment

Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Rural Veteran and Care Partner Walking Program
Mild Cognitive Impairment (MCI)
Not yet recruiting
High-Velocity Resistance Training for Brain Blood Flow and Cognitive Function in Older Adults
At Risk for AD-dementia, With Subjective Cognitive Decline, At Risk for Cognitive Decline
Enrolling by invitation
FES: Effect on Walking in the Real World and Participation in Daily Life in People With Multiple Sclerosis.
Multiple Sclerosis

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.

The record lists no contact. Use the official record to reach the sponsor.

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ADS-5102 in people with Walking Impairment and Multiple Sclerosis, run by Adamas Pharmaceuticals, Inc. at 15 sites in United States.

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 10 inclusion and 19 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 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Safety of ADS-5102 assessed by adverse events, safety-related study drug discontinuations, vital signs, and safety laboratory test (time frame: Up to 4 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 NCT02471222.

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 8 Aug 2017.