An Open Label, Proof of Concept Study to Evaluate the Effects of Dalfampridine Withdrawal on Gait and Balance Parameters in Subjects With Multiple Sclerosis (MS)

An observational study of Multiple Sclerosis, run by Acorda Therapeutics at 1 site in United States.

Completed

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

Trial summary

The purpose of this study is to determine changes on overall gait as well as in multiple gait and balance parameters after withdrawal of dalfampridine-ER 10mg in MS subjects who are receiving the medication consistently for at least two weeks prior to screening. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Multiple Sclerosis
What is being tested?: Withdrawal of dalfampridine-ER 10mg
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Jan 2012to Jun 2012
Phase: Observational
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

Study population: MS Population

Who may be able to join

Diagnosis of multiple sclerosis
Receiving Ampyra® consistently for at least 2 weeks prior to the screening visit
No history of seizures except simple febrile seizures

Who cannot join

Sexually active woman of childbearing potential who is not surgically sterile, <two years post-menopause or is not using effective birth control methods
Subject who is pregnant or breastfeeding

Trial locations and contacts

1 site in 1 country.

United States1 site

OMRF Multiple Sclerosis Center of Excellence
Oklahoma City, Oklahoma, 73104

Other trials in United States

About this study

Official title: An Open-label, Proof of Concept Study to Evaluate Multiple Gait and Balance Parameters After Withdrawal of Dalfampridine-ER 10mg in Subjects With MS

Read the detailed description

Longitudinal study design

Conditions: Multiple Sclerosis
Being tested: Withdrawal of dalfampridine-ER 10mg
Keywords: Multiple Sclerosis, MS
Medical subject headings: Multiple Sclerosis

What participants receive

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

Withdrawal of dalfampridine-ER 10mgOther
Also called Ampyra®
Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)
- On drug Day-7 (visit 1) through Day 1 (visit 2)
- Off drug Day 5±2 days (visit 3) through Day 11±2 days (visit 4)
- On drug Day 15±2 days (visit 5)

Study groups in NCT01535664
Study group	Role	What they receive
dalfampridine-ER 10mg		Subjects with MS taking dalfampridine-ER 10mg and considered to be responders Receives: Other: Withdrawal of dalfampridine-ER 10mg

What is being measured

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

Composite Score Overall Gait After Withdrawal and Reinitiation of Dalfampridine-ER 10mg
The co-primary efficacy variable was overall gait. This novel composite score was created from standardized individual NeuroCom test results (Z-scores).
ZGAIT (Z-Score Gait) is the average of Walk Across (WA) measuring step width, step length, speed; Tandem Walk (TW) measuring step width, speed and end sway, and Step/Quick turn (SQT) measuring turn time and turn sway).
Overall gait was calculated by transforming ZGAIT into a percentile using the standard normal distribution. This rescales the Z-score to a scale from 0 to 100. A higher score is indicative of better performance.
Measured: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)
Composite Score Overall Balance After Withdrawal and Reinitiation of Dalfampridine-ER 10mg
The co-primary efficacy variable was overall balance. This novel composite score was created from standardized individual NeuroCom test results (Z-scores).
Overall balance is a weighted average of Sensory Organization Test (SOT) fixed surface eyes open, fixed surface eyes closed, walls moving eyes open, surface moving eyes open, surface moving eyes closed, surface and walls moving eyes open; Limits of Stability Test (LOS) measuring reaction time, movement velocity, endpoint excursion, maximum excursion and directional control; and Adaptation Test (ADT) measuring the averaged, raw sway and center of force during rotational disturbances. ZBAL (Z-Score Balance)= (ZSOT*0.5) + (ZADT*0.2) + (ZLOS*0.3)
Overall balance was calculated by transforming ZBAL into a percentile using the standard normal distribution. This rescales the Z-score to a scale from 0 to 100. A higher score is indicative of better performance.
Measured: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)

Secondary outcomes (3)

Change on the Berg's Balance Scale (BBS) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg
The BBS is a 14-item scale that evaluates subjects ability to sit, stand, reach, maintain single-leg stance, and turn. The scoring is rated from 0 (cannot perform task) to 4 (normal performance of task) for each of 14 items. The maximum possible score is 56 and the lowest 0. A higher total score is indicative of better performance.
Measured: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)
Change on the Two Minute Walk Test (2MWT) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg
Subjects will walk without assistance for 2 minutes and the distance will be measured and timed by the use of a stop watch.
A larger walking distance is indicative of better performance.
Measured: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)
Change on the Timed 25 Foot Walk Test (T25FW) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg
The T25FW test is a measure of ambulatory function that provides quantitative data and is used widely in the MS population
A higher walking speed is indicative of better performance
Measured: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)

Timeline

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

Jan 2012Jun 2012

First posted20 Feb 2012 (estimated)
Study startJan 2012
Primary completionMay 2012
Study completionJun 2012

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: Observational
Observational model: Cohort
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01535664
Sponsor's protocol ID: AMP-MS-1008
Status last verified: Aug 2013
First submitted: 7 Feb 2012
Last updated: 14 Oct 2013
Results posted: Yes, on ClinicalTrials.gov
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

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Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Proof of Concept Study to Evaluate Multiple Gait and Balance Parameters After Withdrawal of Dalfampridine-ER 10mg in Subjects With MS
ClinicalTrials.gov ID: NCT01535664
Acronym / sponsor ID: AMP-MS-1008
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis, MS
Study type: Observational
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Acorda TherapeuticsIndustry (pharma, biotech, devices)
Collaborators: Prometrika, LLC, BCS Consulting, Inc.
Study start: Jan 2012
Primary completion: May 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 20 Feb 2012 (estimated)
Results: Posted 14 Oct 2013

Clinical summary

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

Detailed description

Longitudinal study design

Study design

Observational model: Cohort
Number of arms: 1

Arm	Type	Receives
dalfampridine-ER 10mg	–	Other: Withdrawal of dalfampridine-ER 10mgSubjects with MS taking dalfampridine-ER 10mg and considered to be responders

Who may qualify

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

Key inclusion criteria (3 listed)

Diagnosis of multiple sclerosis
Receiving Ampyra® consistently for at least 2 weeks prior to the screening visit
No history of seizures except simple febrile seizures

Key exclusion criteria (2 listed)

Sexually active woman of childbearing potential who is not surgically sterile, <two years post-menopause or is not using effective birth control methods
Subject who is pregnant or breastfeeding

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
Withdrawal of dalfampridine-ER 10mgAlso: Ampyra®Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion) * On drug Day-7 (visit 1) through Day 1 (visit 2) * Off drug Day 5±2 days (visit 3) through Day 11±2 days (visit 4) * On drug Day 15±2 days (visit 5)	Other	dalfampridine-ER 10mg

Primary outcome

Composite Score Overall Gait After Withdrawal and Reinitiation of Dalfampridine-ER 10mg
Time frame: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)
The co-primary efficacy variable was overall gait. This novel composite score was created from standardized individual NeuroCom test results (Z-scores). ZGAIT (Z-Score Gait) is the average of Walk Across (WA) measuring step width, step length, speed; Tandem Walk (TW) measuring step width, speed and end sway, and Step/Quick turn (SQT) measuring turn time and turn sway). Overall gait was calculated by transforming ZGAIT into a percentile using the standard normal distribution. This rescales the Z-score to a scale from 0 to 100. A higher score is indicative of better performance.
Composite Score Overall Balance After Withdrawal and Reinitiation of Dalfampridine-ER 10mg
Time frame: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)
The co-primary efficacy variable was overall balance. This novel composite score was created from standardized individual NeuroCom test results (Z-scores). Overall balance is a weighted average of Sensory Organization Test (SOT) fixed surface eyes open, fixed surface eyes closed, walls moving eyes open, surface moving eyes open, surface moving eyes closed, surface and walls moving eyes open; Limits of Stability Test (LOS) measuring reaction time, movement velocity, endpoint excursion, maximum excursion and directional control; and Adaptation Test (ADT) measuring the averaged, raw sway and center of force during rotational disturbances. ZBAL (Z-Score Balance)= (ZSOT*0.5) + (ZADT*0.2) + (ZLOS*0.3) Overall balance was calculated by transforming ZBAL into a percentile using the standard normal distribution. This rescales the Z-score to a scale from 0 to 100. A higher score is indicative of better performance.

3 secondary outcomes

Change on the Berg's Balance Scale (BBS) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg
Time frame: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)
Change on the Two Minute Walk Test (2MWT) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg
Time frame: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)
Change on the Timed 25 Foot Walk Test (T25FW) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg
Time frame: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)

Results and safety

Results posted to the registry on 14 Oct 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dalfampridine-ER 10mg	20	20

Primary outcome: Composite Score Overall Gait After Withdrawal and Reinitiation of Dalfampridine-ER 10mg

Time frame: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11). Mean (Standard Deviation). Unit: units on a scale

Measure	Dalfampridine-ER Withdrawn n = 20	Dalfampridine-ER 10 mg n = 20
Value	46.01 (23.716)	51.40 (21.582)

Dalfampridine-ER Withdrawn vs Dalfampridine-ER 10 mg: Difference in least square means: 4.04 (95% CI 0.87 to 7.20), p = 0.015, Mixed Models Analysis

Population analysed: Full Analysis Population (FAP)

Primary outcome: Composite Score Overall Balance After Withdrawal and Reinitiation of Dalfampridine-ER 10mg

Time frame: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11). Mean (Standard Deviation). Unit: units on a scale

Measure	Dalfampridine-ER Withdrawn n = 20	Dalfampridine-ER 10mg n = 20
Value	55.10 (27.150)	54.98 (24.160)

Dalfampridine-ER Withdrawn vs Dalfampridine-ER 10mg: Difference in least square means: -2.38 (95% CI -8.60 to 3.84), p = 0.434, Mixed Models Analysis

Population analysed: Full Analysis Population (FAP)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Screening Visit (day-7, Visit 1) through 30 days after the last dose of investigational product taken in Period 3 (day 15, visit 5).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dalfampridine-ER 10mg	0 of 20 (0%)	1 of 20 (5%)	Not reported
Dalfampridine-ER Withdrawn	0 of 20 (0%)	5 of 20 (25%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2013.
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.

Gabriel Pardo, MD principal investigator

OMRF Multiple Sclerosis Center of Excellence

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

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis, run by Acorda Therapeutics at 1 site 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 3 inclusion and 2 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 14 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Oct 2013). 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?

Composite Score Overall Gait After Withdrawal and Reinitiation of Dalfampridine-ER 10mg (time frame: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)). The study lists 2 primary outcomes in all. 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 NCT01535664.

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 14 Oct 2013.