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Fampridine- b.i.d

Phase 3

Multiple Sclerosis | Small molecule | Neurology |cbdMD, Inc.|Last Updated: Mar 2, 2012

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment177

FDA Designations

No designations recorded

Clinical trial landscape

Fampridine- b.i.d · 1 trial · 1 indication

Phase 3 1
NCT00654927Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple SclerosisMultiple Sclerosis
COMPLETED177 Analytics
PHASE3COMPLETED
Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis
Multiple SclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Summary of Treatment Emergent Adverse Events (TEAE).
over 7 years (2004-2011)

All adverse events reported were treatment emergent. Therefore, events that had a date of onset, or worsening, on or after the start of the open-label drug and up to 14 days after the last dose (for non-serious events) or up to 30 days after the last dose (for SAEs) were summarized. Any abnormal clinically significant changes in physical examination, medical history, clinical laboratory testing, 12-lead ECG, and standard EEG testing were captured as adverse events.

Secondary Endpoints

Timed 25 Foot Walk (T25FW)
Screening visit, visit 4, every 12 weeks thereafter, Last Regular Visit, Follow Up Visit and Early Termination Visit
Subject Global Impression (SGI)
visit 1 and every clinic visit
Clinician Global Impression of Change (CGIC)
visit 1 and every clinic visit
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
Fampridine-SR b.i.d. (Twice Daily)DRUGDosage form - tablets.
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites22

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 subje...

Countries:United StatesCanada
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Frequently asked questions about Fampridine- b.i.d

What is Fampridine-b.i.d used for?

Fampridine-b.i.d is an investigational small molecule being studied for the treatment of Multiple Sclerosis. It is in Phase 3 clinical development. The drug is being developed by cbdMD, Inc., which trades under the ticker YCBD.

What does Fampridine-b.i.d target?

Fampridine-b.i.d is a small molecule being studied in Multiple Sclerosis. Its specific molecular target has not been disclosed. The drug is in Phase 3 clinical development for this indication.

Who makes Fampridine-b.i.d?

Fampridine-b.i.d is being developed by cbdMD, Inc., a company listed on the stock exchange under the ticker YCBD. The drug is currently in Phase 3 clinical trials for the treatment of Multiple Sclerosis.

What phase is Fampridine-b.i.d in?

Fampridine-b.i.d is in Phase 3 clinical development. It is an investigational drug being studied for Multiple Sclerosis and has not yet been approved by regulatory authorities. The drug is being developed by cbdMD, Inc.

What clinical trials is Fampridine-b.i.d in?

Fampridine-b.i.d has one completed Phase 3 clinical trial, identified as NCT00654927. This open-label extension study evaluated the safety, tolerability, and activity of oral Fampridine-SR in patients with Multiple Sclerosis. The trial enrolled 177 participants in the United States and Canada.

Is Fampridine-b.i.d the same as Fampridine-SR?

Fampridine-b.i.d is also known as Fampridine-SR. The completed Phase 3 clinical trial NCT00654927 evaluated oral Fampridine-SR in patients with Multiple Sclerosis. The drug is being developed by cbdMD, Inc. for this indication.