A Study to Evaluate the Efficacy and Safety of Two Dose Strengths of Dalfampridine Extended Release Tablets. (MILESTONE℠)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02271217 |
|
Recruitment Status :
Completed
First Posted : October 22, 2014
Results First Posted : December 4, 2017
Last Update Posted : June 7, 2018
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Post-Ischemic Stroke | Drug: Placebo Drug: dalfampridine-ER 7.5mg Drug: dalfampridine-ER 10mg | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 377 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | This is a Multi-center, Double-blind, Three Arm, Parallel Group, Placebo-controlled, Randomized Study Designed to Evaluate the Efficacy, Safety and Tolerability of Dalfampridine. |
| Study Start Date : | December 2014 |
| Actual Primary Completion Date : | September 2016 |
| Actual Study Completion Date : | October 2016 |
| Arm | Intervention/treatment |
|---|---|
|
Placebo Comparator: Placebo
Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.
|
Drug: Placebo |
|
Active Comparator: dalfampridine-ER 7.5 mg
Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.
|
Drug: dalfampridine-ER 7.5mg |
|
Active Comparator: dalfampridine-ER 10mg
Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.
|
Drug: dalfampridine-ER 10mg
Other Name: Ampyra |
- Proportion of Subjects Who Show at Least a 20% Improvement on the Two Minute Walk Test (2MinWT) at Week 12 [ Time Frame: Week 12 ]"The 2MinWT measures the distance a subject can walk in 2 minutes. Participants showing at Least a 20% Improvement on the 2MinWT at 12-weeks are considered "Responders".
- Change From Baseline on the Walking Impact Scale (Walk-12) at Week 12 (Key Secondary) [ Time Frame: Baseline, week 12 ]
The Walk-12 is a 12-question questionnaire that asks subjects to rate limitations of their mobility during the preceding two weeks on a 5-point scale (from 1= not at all to 5=extremely). For each visit, the Walk-12 score will be calculated by summing the 12 components and transforming into a scale with a range of 0 to 100. A higher score indicates a greater degree of limitation in walking. A negative change indicates an improvement in walking. 0 = no limitation in mobility to 100 extreme limitation in mobility.
Walk-12 Score = 100 * [(Mean of the 12 items) - 1]/(5-1)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-
Clinical evidence of a stable walking deficit due to an ischemic stroke, as judged by the Investigator, based on review of medical records and physical exam. Such deficit was not present prior to the stroke and cannot be attributed primarily to other conditions (e.g. chronic obstructive pulmonary disease, arthritis). Evidence of walking deficits is objectively supported by any one of the following findings on clinical examination:
- obvious slowness of movement assigned primarily to the stroke
- use of an assistive walking device such as a cane or walker
- Presence of movement pattern deviations such as stiff-legged gait, foot drop, hip hiking and hip circumduction
- Modified Rankin Scale score of 1 - 3, regardless of the cause(s) of the disability
- Sufficient ambulatory ability to independently complete the 2MinWT and 10MWT
- ≥ 6 months from occurrence of most recent stroke
Exclusion Criteria:
- Woman who is not surgically sterile or is less than 2 years postmenopausal, and does not agree to use a highly effective birth control method during the study and up to 3 months after the last dose of investigational product.
- Woman who is pregnant, breastfeeding, or planning to become pregnant
- History of seizures, except simple febrile seizures
- Moderate or severe renal impairment as defined by a calculated creatinine clearance of ≤ 50 mL/minute using the Cockcroft-Gault Equation
- Suicide attempt within 1 year prior to the Screening Visit, or severe suicidal ideation within 6 months prior to the Screening Visit, or subject is at significant risk of suicidal behavior in the opinion of the Investigator
- Previous use of AMPYRA, dalfampridine, fampridine or 4-aminopyridine (4-AP)
- Initiation of a serotonin reuptake inhibitor (SSRI) within 3 months prior to the Screening Visit, or any change in dosing regimen within 3 months prior to the Screening Visit
- Botulinum toxin use within 2 months prior to the Screening Visit
- Orthopedic surgical procedures in any of the extremities within the past 6 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02271217
Show 74 study locations
| Study Director: | Holly Roberts, MD | Acorda Therapeutics |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Acorda Therapeutics |
| ClinicalTrials.gov Identifier: | NCT02271217 |
| Other Study ID Numbers: |
DALF-PS-1016 |
| First Posted: | October 22, 2014 Key Record Dates |
| Results First Posted: | December 4, 2017 |
| Last Update Posted: | June 7, 2018 |
| Last Verified: | September 2017 |
|
Post stroke Ischemic stroke |
|
Ischemic Stroke Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Vascular Diseases Cardiovascular Diseases 4-Aminopyridine Potassium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |