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Two phase 3, multicenter, randomized, placebo-controlled clinical trials of fampridine-SR for treatment of spasticity in chronic spinal cord injury.
Spinal Cord 2014; 52(1):70-6SC

Abstract

STUDY DESIGN

Two randomized, double-blind, placebo-controlled trials.

OBJECTIVE

To evaluate the efficacy and safety of fampridine sustained-release tablets (fampridine-SR) 25 mg twice daily for moderate-to-severe spasticity in patients with chronic spinal cord injury (SCI).

SETTING

United States and Canada.

METHODS

Patients with incomplete chronic SCI were randomized to twice daily fampridine-SR 25 mg or placebo, with a 2-week single-blind placebo run-in, a 2-week titration, 12 weeks of stable dosing, 2 weeks of downward titration and 2 weeks of untreated follow-up. Co-primary end points were the change from baseline, averaged over the double-blind treatment period, for Ashworth score (bilateral knee flexors and extensors) and a 7-point Subject Global Impression of treatment (SGI; 1, terrible; 7, delighted). Secondary end points were: Penn Spasm Frequency Scale; the motor/sensory score from the International Standards for Neurological Classification of SCI; Clinician's Global Impression of Change of neurological status; and the International Index of Erectile Function (men) or the Female Sexual Function Index (women).

RESULTS

The populations were 212 and 203 patients in the two studies, respectively. Changes from baseline in Ashworth score were -0.15 (placebo) and -0.19 (fampridine-SR) in the first study, and -0.16 (placebo) and -0.28 (fampridine-SR) in the second study. The between-treatment difference was not significant for either the Ashworth score or the SGI and, with few exceptions, neither were the secondary end points. Fampridine-SR was generally well tolerated; treatment-emergent adverse events (TEAEs) and serious TEAEs were reported with similar frequency between treatments.

CONCLUSION

Fampridine-SR was well tolerated. No significant differences were observed between treatment groups for the primary end points of Ashworth score and SGI.

Authors+Show Affiliations

Department of Rehabilitation Medicine, University of Miami, Miami, FL, USA.Department of Rehabilitation Medicine, Thomas Jefferson University, Philadelphia, PA, USA.Department of Rehabilitation Medicine, Jefferson Medical College of Thomas Jefferson University, Philadelphia, PA, USA.Department of Physical Medicine and Rehabilitation, University of Alabama at Birmingham, Birmingham, AL, USA.Research Department, Craig Hospital, Englewood, CO, USA.Department of Physical Medicine and Rehabilitation, Parkwood Hospital, St Joseph's Health Care, London, Ontario, Canada.Department of Physical Medicine and Rehabilitation, Veterans Affairs Medical Center, Birmingham, AL, USA.Acorda Therapeutics, Inc., Ardsley, NY, USA.Acorda Therapeutics, Inc., Ardsley, NY, USA.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24216616

Citation

Cardenas, D D., et al. "Two Phase 3, Multicenter, Randomized, Placebo-controlled Clinical Trials of fampridine-SR for Treatment of Spasticity in Chronic Spinal Cord Injury." Spinal Cord, vol. 52, no. 1, 2014, pp. 70-6.
Cardenas DD, Ditunno JF, Graziani V, et al. Two phase 3, multicenter, randomized, placebo-controlled clinical trials of fampridine-SR for treatment of spasticity in chronic spinal cord injury. Spinal Cord. 2014;52(1):70-6.
Cardenas, D. D., Ditunno, J. F., Graziani, V., McLain, A. B., Lammertse, D. P., Potter, P. J., ... Blight, A. R. (2014). Two phase 3, multicenter, randomized, placebo-controlled clinical trials of fampridine-SR for treatment of spasticity in chronic spinal cord injury. Spinal Cord, 52(1), pp. 70-6. doi:10.1038/sc.2013.137.
Cardenas DD, et al. Two Phase 3, Multicenter, Randomized, Placebo-controlled Clinical Trials of fampridine-SR for Treatment of Spasticity in Chronic Spinal Cord Injury. Spinal Cord. 2014;52(1):70-6. PubMed PMID: 24216616.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Two phase 3, multicenter, randomized, placebo-controlled clinical trials of fampridine-SR for treatment of spasticity in chronic spinal cord injury. AU - Cardenas,D D, AU - Ditunno,J F, AU - Graziani,V, AU - McLain,A B, AU - Lammertse,D P, AU - Potter,P J, AU - Alexander,M S, AU - Cohen,R, AU - Blight,A R, Y1 - 2013/11/12/ PY - 2013/05/13/received PY - 2013/09/23/revised PY - 2013/10/02/accepted PY - 2013/11/13/entrez PY - 2013/11/13/pubmed PY - 2014/8/26/medline SP - 70 EP - 6 JF - Spinal cord JO - Spinal Cord VL - 52 IS - 1 N2 - STUDY DESIGN: Two randomized, double-blind, placebo-controlled trials. OBJECTIVE: To evaluate the efficacy and safety of fampridine sustained-release tablets (fampridine-SR) 25 mg twice daily for moderate-to-severe spasticity in patients with chronic spinal cord injury (SCI). SETTING: United States and Canada. METHODS: Patients with incomplete chronic SCI were randomized to twice daily fampridine-SR 25 mg or placebo, with a 2-week single-blind placebo run-in, a 2-week titration, 12 weeks of stable dosing, 2 weeks of downward titration and 2 weeks of untreated follow-up. Co-primary end points were the change from baseline, averaged over the double-blind treatment period, for Ashworth score (bilateral knee flexors and extensors) and a 7-point Subject Global Impression of treatment (SGI; 1, terrible; 7, delighted). Secondary end points were: Penn Spasm Frequency Scale; the motor/sensory score from the International Standards for Neurological Classification of SCI; Clinician's Global Impression of Change of neurological status; and the International Index of Erectile Function (men) or the Female Sexual Function Index (women). RESULTS: The populations were 212 and 203 patients in the two studies, respectively. Changes from baseline in Ashworth score were -0.15 (placebo) and -0.19 (fampridine-SR) in the first study, and -0.16 (placebo) and -0.28 (fampridine-SR) in the second study. The between-treatment difference was not significant for either the Ashworth score or the SGI and, with few exceptions, neither were the secondary end points. Fampridine-SR was generally well tolerated; treatment-emergent adverse events (TEAEs) and serious TEAEs were reported with similar frequency between treatments. CONCLUSION: Fampridine-SR was well tolerated. No significant differences were observed between treatment groups for the primary end points of Ashworth score and SGI. SN - 1476-5624 UR - https://www.unboundmedicine.com/medline/citation/24216616/Two_phase_3_multicenter_randomized_placebo_controlled_clinical_trials_of_fampridine_SR_for_treatment_of_spasticity_in_chronic_spinal_cord_injury_ L2 - http://dx.doi.org/10.1038/sc.2013.137 DB - PRIME DP - Unbound Medicine ER -