|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2017 |
|
Main ID: |
NCT00654927 |
|
Date of registration:
|
04/04/2008 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis
|
|
Scientific title:
|
Phase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis |
|
Date of first enrolment:
|
November 2003 |
|
Target sample size:
|
177 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00654927 |
|
Study type:
|
Interventional |
|
Study design:
|
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Canada
|
United States
| | | | | | |
|
Contacts
|
|
Name:
|
Bonnie Faust |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Acorda Therapeutics |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- The subject must have been previously enrolled in an Acorda Therapeutics or an Elan
Corporation sponsored study for multiple sclerosis and received either Fampridine or
placebo.
- The subject must have multiple sclerosis as determined by the Principal Investigator.
- The subject, male or female, must be at least 18 years of age. Any subject who is now
over the age of 70 must be in good overall health in the judgment of the Investigator.
- The subject must be of adequate cognitive function, as judged by the Investigator.
- Any subject who is female and of childbearing potential, regardless of sexual
activity, must have a negative urine pregnancy test at the Screening Visit.
Exclusion Criteria:
- The subject is a female who is either pregnant or breastfeeding, or of child-bearing
potential, who, if engaged in active heterosexual relations and has not had a
hysterectomy or bilateral oophorectomy, would not use one of the following birth
control methods: tubal ligation, implantable contraception device, oral, injectable or
transdermal contraceptive, barrier method or sexual activity restricted to
vasectomized partner.
- The subject withdrew from a previous Fampridine study because of a Serious Adverse
Event that was possibly, probably or definitely related to Fampridine.
- The subject has a history of seizures or has evidence of past, or possible,
epileptiform activity on an EEG.
- The subject has either a clinically significant abnormal ECG or laboratory value(s) at
the Screening Visit, as judged by the Investigator
- The subject has angina, uncontrolled hypertension, clinically significant cardiac
arrhythmias, or any other clinically significant cardiovascular abnormality, as judged
by the Investigator.
- The subject has a known allergy to pyridine-containing substances or any of the
inactive ingredients of the Fampridine tablet
- The subject has received an investigational drug, except for Fampridine- SR (or
matching placebo) under Protocol MS-F202, within 30 days prior to the Screening Visit;
or the subject is scheduled to enroll in an investigational drug trial at any time
during this study.
- The subject has received compounded 4-aminopyridine (4-AP) within 14 days of the
Screening Visit.
- The subject has had an onset of an MS exacerbation within 30 days prior to the
Screening Visit, or, if in the judgment of the Investigator, has not stabilized from a
prior exacerbation episode.
- The subject has started on a concomitant medication regimen for an underlying
disease/symptom within the past 7 days; or has started an interferon or
chemotherapeutic agent for multiple sclerosis within the past 4 weeks.
- The subject has a history of drug or alcohol abuse within the past year.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Multiple Sclerosis
|
|
Intervention(s)
|
|
Drug: Fampridine-SR b.i.d. (Twice Daily)
|
|
Primary Outcome(s)
|
|
Summary of Treatment Emergent Adverse Events (TEAE).
[Time Frame: over 7 years (2004-2011)]
|
|
Secondary Outcome(s)
|
|
Subject Global Impression (SGI)
[Time Frame: visit 1 and every clinic visit]
|
|
Timed 25 Foot Walk (T25FW)
[Time Frame: Screening visit, visit 4, every 12 weeks thereafter, Last Regular Visit, Follow Up Visit and Early Termination Visit]
|
|
Expanded Disability Status Scale (EDSS)
[Time Frame: Screening visit, visit 6 and every 24 months thereafter]
|
|
Clinician Global Impression of Change (CGIC)
[Time Frame: visit 1 and every clinic visit]
|
|
Secondary ID(s)
|
|
MS-F202 EXT
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|