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A Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00800215
First received: December 1, 2008
Last updated: February 22, 2010
Last verified: February 2010
History of Changes

December 1, 2008
February 22, 2010
March 2004
August 2004   (final data collection date for primary outcome measure)
Adverse events, Vital signs, electrocardiograms,Physical examination, neurological examination [ Time Frame: 2 Days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00800215 on ClinicalTrials.gov Archive Site
Seizure counts [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927
A Multicenter, Double-blind, Double-dummy, Randomized Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927 as Replacement for Oral SPM 927 in Subjects With Partial Seizures With or Without Secondary Generalization

The purpose of this trial was to evaluate the safety and tolerability of SPM 927 when given as iv infusions compared with oral administration of the same dose strengths in subjects who were receiving oral SPM 927 for partial seizures with or without secondary generalization.

Trial procedures will include medical history update, physical/ neurological exams, ECGs, blood /urine sample collections and seizure diary completion.

Subjects completing the trial will return to the OLE trial to resume dosing with oral SPM 927.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Epilepsy
  • Drug: iv SPM 927 and oral placebo tablet
    60-minute infusion iv SPM 927 and oral placebo tablet
    Other Names:
    • Lacosamide
    • Vimpat
  • Drug: oral SPM 927 tablet and iv placebo
    60-minute infusion placebo and oral SPM 927 tablet
    Other Names:
    • Lacosamide
    • Vimpat
  • Drug: iv SPM 927 and oral placebo tablet
    30-minute infusion iv SPM 927 and oral placebo tablet
    Other Names:
    • Lacosamide
    • Vimpat
  • Drug: oral SPM 927 tablet and iv placebo
    30-minute infusion placebo and oral SPM 927 tablet
    Other Names:
    • Lacosamide
    • Vimpat
  • Experimental: 1
    Intervention: Drug: iv SPM 927 and oral placebo tablet
  • Placebo Comparator: 2
    Intervention: Drug: oral SPM 927 tablet and iv placebo
  • Experimental: 3
    Intervention: Drug: iv SPM 927 and oral placebo tablet
  • Placebo Comparator: 4
    Intervention: Drug: oral SPM 927 tablet and iv placebo
Biton V, Rosenfeld WE, Whitesides J, Fountain NB, Vaiciene N, Rudd GD. Intravenous lacosamide as replacement for oral lacosamide in patients with partial-onset seizures. Epilepsia. 2008 Mar;49(3):418-24. Epub 2007 Sep 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
November 2004
August 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject with partial seizures with or without secondary generalization

Exclusion Criteria:

  • Subject had previously received iv SPM 927
  • Subject met the withdrawal criteria for the open-label extension trial with SPM 927 or was experiencing an ongoing serious adverse event.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00800215
SP616
Yes
Study Director, UCB
UCB, Inc.
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB, Inc.
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP