Main
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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:
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ClinicalTrials.gov |
Last refreshed on:
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19 October 2017 |
Main ID: |
NCT01535664 |
Date of registration:
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07/02/2012 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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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)
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Scientific title:
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An Open-label, Proof of Concept Study to Evaluate Multiple Gait and Balance Parameters After Withdrawal of Dalfampridine-ER 10mg in Subjects With MS |
Date of first enrolment:
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January 2012 |
Target sample size:
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20 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT01535664 |
Study type:
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Observational |
Study design:
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Phase:
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Countries of recruitment
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United States
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Contacts
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Name:
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Gabriel Pardo, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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OMRF Multiple Sclerosis Center of Excellence |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
Exclusion Criteria:
- Sexually active woman of childbearing potential who is not surgically sterile, years post-menopause or is not using effective birth control methods
- Subject who is pregnant or breastfeeding
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Other: Withdrawal of dalfampridine-ER 10mg
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Primary Outcome(s)
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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)]
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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)]
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Secondary Outcome(s)
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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)]
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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)]
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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)]
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Secondary ID(s)
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AMP-MS-1008
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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