Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis

This study has been completed.

Study NCT00053417 Information provided by Acorda Therapeutics

First Received on January 29, 2003. Last Updated on August 3, 2011 History of Changes

Results First Received: May 16, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Multiple Sclerosis
Interventions:	Drug: Placebo Drug: 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP) Drug: 15 mg fampridine-SR (4-aminopyridine, 4-AP) Drug: 20 mg fampridine-SR (4-aminopyridine, 4-AP)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients with clinically definite MS were recruited at clinics within the US and Canada

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
2-week placebo run-in

Reporting Groups

	Description
Placebo	Placebo control
10 mg Fampridine Twice a Day (b.i.d.)	fampridine, oral, 10 mg administered twice daily
15 mg Fampridine b.i.d.	fampridine, oral, 15 mg administered twice daily
20 mg Fampridine b.i.d.	fampridine, oral, 20 mg administered twice daily

Participant Flow: Overall Study

	Placebo	10 mg Fampridine Twice a Day (b.i.d.)	15 mg Fampridine b.i.d.	20 mg Fampridine b.i.d.
STARTED	47	52	50	57
COMPLETED	45	50	49	51
NOT COMPLETED	2	2	1	6
Adverse Event	1	0	1	5
Non-Compliance	0	0	0	1
Withdrawal by Subject	0	1	0	0
Lost to Follow-up	1	1	0	0

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Placebo control
10 mg Fampridine Twice a Day (b.i.d.)	fampridine, oral, 10 mg administered twice daily
15 mg Fampridine b.i.d.	fampridine, oral, 15 mg administered twice daily
20 mg Fampridine b.i.d.	fampridine, oral, 20 mg administered twice daily

Baseline Measures

	Placebo	10 mg Fampridine Twice a Day (b.i.d.)	15 mg Fampridine b.i.d.	20 mg Fampridine b.i.d.	Total
Number of Participants [units: participants]	47	52	50	57	206
Age [units: participants]
<=18 years	0	0	0	0	0
Between 18 and 65 years	45	50	49	55	199
>=65 years	2	2	1	2	7
Age [units: years] Mean ± Standard Deviation	49.0 ± 8.99	49.8 ± 8.34	47.7 ± 8.93	52.2 ± 8.33	49.8 ± 8.73
Gender [units: participants]
Female	27	36	34	34	131
Male	20	16	16	23	75
Region of Enrollment [units: participants]
United States	42	47	45	51	185
Canada	5	5	5	6	21

Outcome Measures

1. Primary:

Median Percent Change From Baseline in Average Walking Speed on Timed 25-Foot Walk Test [ Time Frame: Baseline (placebo run-in period); 12-week stable dose period ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The INSTITUTION shall submit any such manuscript or release to the SPONSOR for comment prior to publication or release at least forty-five (45) days in advance of submission for publication. If the parties disagree concerning appropriateness of the data analysis and presentation, INSTITUTION agrees to meet with SPONSOR’s representatives for the purpose of making good faith efforts to discuss and resolve any issues or disagreement.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Andrew Blight, PhD
Organization: Acorda Therapeutics
phone: 914-347-4300 ext 102
e-mail: ablight@acorda.com

No publications provided

Responsible Party:	Andrew Blight/Chief Scientific Officer, Acorda Therapeutics
ClinicalTrials.gov Identifier:	NCT00053417 History of Changes
Other Study ID Numbers:	MS-F202
Study First Received:	January 29, 2003
Results First Received:	May 16, 2011
Last Updated:	August 3, 2011
Health Authority:	United States: Food and Drug Administration