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Potassium Channel Blocker

Dalfampridine for ALS

Phase 1
Waitlist Available
Led By Dale Lange, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of upper motor neuron disease, compatible with PLS but may include upper motor neuron (UMN) predominant ALS, defined as only upper motor neuron (UMN) features in at least 2 body regions on examination
Mini Mental Status Score > 22 and deemed by the PI of being capable of providing informed consent and following trial procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over the course of study at weeks 2, 4, 6, 10, 14, 18
Awards & highlights

Study Summary

This trial will study the safety and tolerability of a new medication for people with primary lateral sclerosis or upper motor neuron predominate ALS. A total of 35 subjects will be enrolled and will be given the medication to take for 18 weeks. The study will measure the subjects' ability to walk during that time period. A consistent responder will be defined as improvement in 3 of 4 Timed 25Foot Walk while on medication, compared with the baseline results while off medication.

Who is the study for?
This trial is for adults aged 18-99 with primary lateral sclerosis (PLS) or upper motor neuron predominant ALS. Participants must have stable walking impairment, no severe allergies to dalfampridine, and a forced vital capacity over 60%. Women must use effective birth control. Exclusions include pregnancy, recent experimental drug use, certain medical conditions like liver disease or seizures, and metal implants above the neck.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of dalfampridine in improving walking speed in PLS/ALS patients over an 18-week period. It involves repeated timed walks to measure any improvement while on medication compared to baseline performance without medication.See study design
What are the potential side effects?
Dalfampridine can cause side effects such as difficulty sleeping, dizziness, nausea, headache, weakness, back pain and balance problems. In rare cases it may increase seizure risk; hence it's not given to those with a history of seizures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a condition affecting my brain's nerve cells, showing symptoms in at least 2 body areas.
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I am mentally capable of understanding and following the trial's procedures.
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I haven't taken any drugs for PLS or ALS in the last 30 days.
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I have some difficulty walking but can still walk.
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I am between 18 and 99 years old.
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I cannot become pregnant or am using effective birth control.
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I haven't taken Riluzole in the last 30 days or am on a stable dose.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over the course of study at weeks 2, 4, 6, 10, 14, 18
This trial's timeline: 3 weeks for screening, Varies for treatment, and over the course of study at weeks 2, 4, 6, 10, 14, 18 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
consistent improvement in the Timed 25 Foot Walk test
Secondary outcome measures
Effect of Dalfampridine on quality of life
Effects of Dalfampridine on functional status

Trial Design

1Treatment groups
Experimental Treatment
Group I: AmpyraExperimental Treatment1 Intervention
Ampyra open label
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
dalfampridine
2013
Completed Phase 4
~90

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,051 Previous Clinical Trials
1,329,710 Total Patients Enrolled
Hospital for Special Surgery, New YorkLead Sponsor
241 Previous Clinical Trials
61,827 Total Patients Enrolled
Dale Lange, MDPrincipal InvestigatorHSS

Media Library

Dalfampridine (Potassium Channel Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT02868567 — Phase 1
Motor Neuron Disease or Amyotrophic Lateral Sclerosis Research Study Groups: Ampyra
Motor Neuron Disease or Amyotrophic Lateral Sclerosis Clinical Trial 2023: Dalfampridine Highlights & Side Effects. Trial Name: NCT02868567 — Phase 1
Dalfampridine (Potassium Channel Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02868567 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cap for participant enrollments in this clinical trial?

"As of September 30th 2022, this trial is no longer recruiting. Initially posted on March 1st 2016, the study has since been completed or suspended. If you are looking for other trials involving motor neuron disease and upper dalfampridine, there are 134 studies and 5 studies respectively actively seeking participants."

Answered by AI

Has dalfampridine satisfied the FDA's regulatory criteria for public use?

"Considering the sparse evidence of efficacy and safety, dalfampridine was given a rating of 1 on our risk scale."

Answered by AI

Does this clinical research currently have availability for participants?

"According to clinicaltrials.gov, this investigation is not presently accepting new trial participants. Originally posted on March 1st 2016 and updated lastly on September 30th 2022, the study no longer needs candidates; however there are 139 other studies that still require enrolment."

Answered by AI

Could you elaborate on any other research experiments that have been carried out with dalfampridine?

"First trialled in 2016 at Shara Holzberg, dalfampridine has since then been the subject of 36 completed medical studies. Five additional trials are currently underway with many occurring in Boston, Massachusetts."

Answered by AI

What are the criteria for a potential participant in this experiment?

"To be considered for participation in this clinical trial, interested parties must have upper-body motor neuron disease and meet the age criteria of 18 to 99 years old. A total of 35 participants are sought after."

Answered by AI

Is there an upper age limit for participants in this experimental protocol?

"This clinical trial is open to participants of legal age (18+) and up to 99 years old."

Answered by AI
~1 spots leftby Jul 2024