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Efficacy and safety study of arbaclofen placarbil in patients with spasticity due to spinal cord injury.

Abstract

STUDY DESIGN

Randomized, double-blind, placebo-controlled, two-period crossover.

OBJECTIVES

To evaluate the efficacy and safety of arbaclofen placarbil (AP) in patients with spasticity secondary to spinal cord injury (SCI).

SETTING

United States and Canada.

METHODS

Patients received extended-release AP tablets 10, 20 or 30 mg every 12 h in one of two AP/placebo sequences, with 26 days of each treatment. The primary analysis compared Ashworth scale assessments of muscle tone between AP and placebo for the muscle group with maximum baseline Ashworth score. Secondary endpoints included a patient-rated Severity of Spasticity Scale.

RESULTS

In the primary analysis, AP significantly improved Ashworth scores compared with placebo over the dosing interval: least-squares mean reduction versus placebo was 0.60 for AP 20 mg (P=0.0059) and 0.88 for AP 30 mg (P=0.0007). The difference was significant for the pre-morning dose time point, 12 h after the prior evening dose, indicating that efficacy was maintained throughout the dosing interval. Treatment differences for AP 10 mg versus placebo were not significant. Severity of Spasticity ratings were significantly reduced for the combined 20/30-mg group versus placebo (P=0.018). No statistically significant differences between AP and placebo were observed for muscle strength. AP-related AEs were generally mild to moderate in intensity, and none led to early withdrawal or were serious.

CONCLUSION

AP was well tolerated at all investigated dosages and, when administered at doses of 20 or 30 mg twice daily, was efficacious in reducing spasticity due to SCI.

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  • Authors+Show Affiliations

    ,

    Physical Medicine and Rehabilitation, University of California-Irvine, Orange, CA, USA.

    , , , , ,

    Source

    Spinal cord 49:9 2011 Sep pg 974-80

    MeSH

    Adult
    Baclofen
    Cross-Over Studies
    Delayed-Action Preparations
    Double-Blind Method
    Female
    Humans
    Male
    Middle Aged
    Muscle Relaxants, Central
    Muscle Spasticity
    Placebos
    Spinal Cord Injuries
    Young Adult

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    21577221

    Citation

    Nance, P W., et al. "Efficacy and Safety Study of Arbaclofen Placarbil in Patients With Spasticity Due to Spinal Cord Injury." Spinal Cord, vol. 49, no. 9, 2011, pp. 974-80.
    Nance PW, Huff FJ, Martinez-Arizala A, et al. Efficacy and safety study of arbaclofen placarbil in patients with spasticity due to spinal cord injury. Spinal Cord. 2011;49(9):974-80.
    Nance, P. W., Huff, F. J., Martinez-Arizala, A., Ayyoub, Z., Chen, D., Bian, A., & Stamler, D. (2011). Efficacy and safety study of arbaclofen placarbil in patients with spasticity due to spinal cord injury. Spinal Cord, 49(9), pp. 974-80. doi:10.1038/sc.2011.43.
    Nance PW, et al. Efficacy and Safety Study of Arbaclofen Placarbil in Patients With Spasticity Due to Spinal Cord Injury. Spinal Cord. 2011;49(9):974-80. PubMed PMID: 21577221.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Efficacy and safety study of arbaclofen placarbil in patients with spasticity due to spinal cord injury. AU - Nance,P W, AU - Huff,F J, AU - Martinez-Arizala,A, AU - Ayyoub,Z, AU - Chen,D, AU - Bian,A, AU - Stamler,D, Y1 - 2011/05/17/ PY - 2011/5/18/entrez PY - 2011/5/18/pubmed PY - 2012/6/23/medline SP - 974 EP - 80 JF - Spinal cord JO - Spinal Cord VL - 49 IS - 9 N2 - STUDY DESIGN: Randomized, double-blind, placebo-controlled, two-period crossover. OBJECTIVES: To evaluate the efficacy and safety of arbaclofen placarbil (AP) in patients with spasticity secondary to spinal cord injury (SCI). SETTING: United States and Canada. METHODS: Patients received extended-release AP tablets 10, 20 or 30 mg every 12 h in one of two AP/placebo sequences, with 26 days of each treatment. The primary analysis compared Ashworth scale assessments of muscle tone between AP and placebo for the muscle group with maximum baseline Ashworth score. Secondary endpoints included a patient-rated Severity of Spasticity Scale. RESULTS: In the primary analysis, AP significantly improved Ashworth scores compared with placebo over the dosing interval: least-squares mean reduction versus placebo was 0.60 for AP 20 mg (P=0.0059) and 0.88 for AP 30 mg (P=0.0007). The difference was significant for the pre-morning dose time point, 12 h after the prior evening dose, indicating that efficacy was maintained throughout the dosing interval. Treatment differences for AP 10 mg versus placebo were not significant. Severity of Spasticity ratings were significantly reduced for the combined 20/30-mg group versus placebo (P=0.018). No statistically significant differences between AP and placebo were observed for muscle strength. AP-related AEs were generally mild to moderate in intensity, and none led to early withdrawal or were serious. CONCLUSION: AP was well tolerated at all investigated dosages and, when administered at doses of 20 or 30 mg twice daily, was efficacious in reducing spasticity due to SCI. SN - 1476-5624 UR - https://www.unboundmedicine.com/medline/citation/21577221/Efficacy_and_safety_study_of_arbaclofen_placarbil_in_patients_with_spasticity_due_to_spinal_cord_injury_ L2 - http://dx.doi.org/10.1038/sc.2011.43 DB - PRIME DP - Unbound Medicine ER -