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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: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT01535664
Date of registration: 07/02/2012
Prospective Registration: No
Primary sponsor: Acorda Therapeutics
Public title: 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)
Scientific title: 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: January 2012
Target sample size: 20
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01535664
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
United States
Contacts
Name:     Gabriel Pardo, MD
Address: 
Telephone:
Email:
Affiliation:  OMRF Multiple Sclerosis Center of Excellence
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Multiple Sclerosis
Intervention(s)
Other: Withdrawal of dalfampridine-ER 10mg
Primary Outcome(s)
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and Reinitiation of Dalfampridine-ER 10mg [Time Frame: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)]
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and Reinitiation of Dalfampridine-ER 10mg [Time Frame: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)]
Secondary Outcome(s)
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and Reinitiation of Dalfampridine-ER 10mg [Time Frame: 11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)]
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)]
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)]
Secondary ID(s)
AMP-MS-1008
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
BCS Consulting, Inc.
Prometrika, LLC
Ethics review
Results
Results available: Yes
Date Posted: 14/10/2013
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01535664
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