Multiple SclerosisPhase 4NCT01356940
A Placebo Controlled Trial of Dalfampridine ER for Ambulatory Activity in People With Multiple Sclerosis
A Phase 4 study testing dalfampridine ER in people with Multiple Sclerosis, run by Brown, Theodore R., M.D., MPH at 1 site in United States.
Trial summary
A randomized placebo controlled double-blind cross-over trial of Dalfampridine ER for effect on ambulatory activity in people with multiple sclerosis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- dalfampridine ER
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Apr 2013
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of MS made at least 3 months prior to based McDonald or Proser criteria.
- Age 18-75 years old inclusive.
- Expanded Disability Status Scale (EDS) 0-6.5
- Clinical stability defined as no MS exacerbation or change in disease modifying therapy for 60 days prior to screening.
- Screening 6-minute walking test distance between 50m-500m, inclusive.
- Written informed consent.
Who cannot join
- use of 4-aminopyridine within 6 months of screening
- Any contraindication to DER:
- Allergy to DER
- history of seizure disorder or history of EEG showing epileptiform activity
- Renal insufficiency (estimated GFR < 60.
- Any condition that would exclude 6 minute walking testing:
Show all 19Show fewer
- Cardiac surgery or myocardial infarction within the last 3 months.
- Severe aortic stenosis or hypertropic cardiomyopathy.
- Pulmonary embolus or infarction in the last 6 months.
- Uncontrolled hypertension by history or by screening or baseline diastolic blood pressure > 170, or systolic blood pressure > 105.
- Use of oxygen at home for 24 hours/day or severe lung disease.
- History of ventricular arrhythmia or finding of significant ventricular arrhythmia. atrial arrhythmia or 2nd or 3rd degree heart block on screening ECG.
- Concomitant neurological disease, such as ALS, Parkinson Disease, stroke.
- Hospitalization in the last 6 months for psychiatric illness.
- Alcohol or drug abuse within the past year.
- Females who are breast-feeding, pregnant or have potential to become pregnant during the course of the study( fertile and unwilling/unable to use effective contraceptive measures)
- Cognitive deficits that would interfere with the subject's ability to give informed consent or preform study testing.
- Any other serious and/or unstable medical condition.
- Use of mitoxantrone (Novantrone) within 6 months of baseline visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Double-blind Cross-over Trial of Dalfampridine ER for Effect on Ambulatory Activity in People With Multiple Sclerosis
A randomized placebo controlled double-blind cross-over trial of Dalfampridine ER for effect on ambulatory activity in people with multiple sclerosis
Read the detailed description
This is a parallel-group, double-blind, randomized controlled crossover trial with a 1:1 randomization. There are two treatment periods of 4 weeks and a two-week off treatment washout period. Treatment periods are DER (dalfampridine ER) followed by placebo (group A) and placebo followed by DER (group B), respectively. All dosages will be administered twice a week. Purpose of the study is to see if using the study drug(dalfampridine Er) for a short period of time will improve the way subjects with multiple sclerosis (MS) walk.
- Conditions
- Multiple Sclerosis
- Being tested
- dalfampridine ER, placebo
- Keywords
- Ambulation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dalfampridine ERDrug
Also called Ampyra serial number 77948545
dalfampridine ER 10mg bid for 4 weeks
placeboDrug
Also called Sugar Pill
identical placebo tablet administered bid for four weeks
| Study group | Role | What they receive |
|---|---|---|
| dalfampridine ER 10mg bid-placebo | Active comparator | 4 week administration of dalfampridine ER 10mg bid followed by 2 week washout and 4 weeks of placebo control Receives: Drug: dalfampridine ER; Drug: placebo |
| placebo-dalfampridine ER 10mg bid | Placebo comparator | placebo tablet administered bid for four weeks followed by 2 week washout and 4 weeks of dalfampridine ER 10mg bid Receives: Drug: dalfampridine ER; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Activity Index
peak activity index is a measure of the 30 fastest minutes of walking over a 24 hour period, averaged over one week of accelerometer wear. Measurement is change from baseline to 4 weeks on intervention
Measured: 10 weeks
Secondary outcomes (1)
Stepcount
change in daily stepcount recorded by an accelerometer and averaged over 1 week of wear baseline vs 4 weeks
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2011 (estimated)
- Study startNov 2010
- Primary completionApr 2013
- Study completionApr 2013
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown, Theodore R., M.D., MPH
- Collaborators
- Acorda Therapeutics
- Responsible party
- Principal investigator, Theodore R Brown, Brown, Theodore R., M.D., MPH
- Investigators
- Theodore R Brown, MD, Principal investigator, EvergreenHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01356940
- Sponsor's protocol ID
- A randomized
- Status last verified
- Oct 2018
- First submitted
- 18 May 2011
- Last updated
- 31 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Double-blind Cross-over Trial of Dalfampridine ER for Effect on Ambulatory Activity in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01356940
- Acronym / sponsor ID
- A randomized
- Conditions
- Multiple Sclerosis
- Keywords
- Ambulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Brown, Theodore R., M.D., MPH
- Collaborators
- Acorda Therapeutics
- Study start
- Nov 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 20 May 2011 (estimated)
- Results
- Posted 9 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized placebo controlled double-blind cross-over trial of Dalfampridine ER for effect on ambulatory activity in people with multiple sclerosis
Detailed description
This is a parallel-group, double-blind, randomized controlled crossover trial with a 1:1 randomization. There are two treatment periods of 4 weeks and a two-week off treatment washout period. Treatment periods are DER (dalfampridine ER) followed by placebo (group A) and placebo followed by DER (group B), respectively. All dosages will be administered twice a week. Purpose of the study is to see if using the study drug(dalfampridine Er) for a short period of time will improve the way subjects with multiple sclerosis (MS) walk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dalfampridine ER 10mg bid-placebo | Active comparator | Drug: dalfampridine ER, Drug: placebo4 week administration of dalfampridine ER 10mg bid followed by 2 week washout and 4 weeks of placebo control |
| placebo-dalfampridine ER 10mg bid | Placebo comparator | Drug: dalfampridine ER, Drug: placeboplacebo tablet administered bid for four weeks followed by 2 week washout and 4 weeks of dalfampridine ER 10mg bid |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of MS made at least 3 months prior to based McDonald or Proser criteria.
- Age 18-75 years old inclusive.
- Expanded Disability Status Scale (EDS) 0-6.5
- Clinical stability defined as no MS exacerbation or change in disease modifying therapy for 60 days prior to screening.
- Screening 6-minute walking test distance between 50m-500m, inclusive.
Key exclusion criteria (19 listed)
- use of 4-aminopyridine within 6 months of screening
- Any contraindication to DER:
- Any condition that would exclude 6 minute walking testing:
- History of ventricular arrhythmia or finding of significant ventricular arrhythmia. atrial arrhythmia or 2nd or 3rd degree heart block on screening ECG.
- Concomitant neurological disease, such as ALS, Parkinson Disease, stroke.
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 |
|---|---|---|
| dalfampridine ERAlso: Ampyra serial number 77948545dalfampridine ER 10mg bid for 4 weeks | Drug | dalfampridine ER 10mg bid-placebo, placebo-dalfampridine ER 10mg bid |
| placeboAlso: Sugar Pillidentical placebo tablet administered bid for four weeks | Drug | dalfampridine ER 10mg bid-placebo, placebo-dalfampridine ER 10mg bid |
Primary outcome
Peak Activity Index
Time frame: 10 weeks
peak activity index is a measure of the 30 fastest minutes of walking over a 24 hour period, averaged over one week of accelerometer wear. Measurement is change from baseline to 4 weeks on intervention
1 secondary outcome
Stepcount
Time frame: 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
- 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.
Theodore R Brown, MD principal investigator
EvergreenHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dalfampridine ER in people with Multiple Sclerosis, run by Brown, Theodore R., M.D., MPH 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 6 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 31 Oct 2018. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 9 Apr 2015). 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?
Peak Activity Index (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2018.