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Trial record 1 of 1 for:    NCT00800215
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A Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00800215
Recruitment Status : Completed
First Posted : December 2, 2008
Last Update Posted : May 27, 2015
Sponsor:
Information provided by:
UCB Pharma

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Epilepsy Drug: iv SPM 927 and oral placebo tablet Drug: oral SPM 927 tablet and iv placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2004
Actual Primary Completion Date : August 2004
Actual Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Arm Intervention/treatment
Experimental: 1 Drug: iv SPM 927 and oral placebo tablet
60-minute infusion iv SPM 927 and oral placebo tablet
Other Names:
  • Lacosamide
  • Vimpat

Placebo Comparator: 2 Drug: oral SPM 927 tablet and iv placebo
60-minute infusion placebo and oral SPM 927 tablet
Other Names:
  • Lacosamide
  • Vimpat

Experimental: 3 Drug: iv SPM 927 and oral placebo tablet
30-minute infusion iv SPM 927 and oral placebo tablet
Other Names:
  • Lacosamide
  • Vimpat

Placebo Comparator: 4 Drug: oral SPM 927 tablet and iv placebo
30-minute infusion placebo and oral SPM 927 tablet
Other Names:
  • Lacosamide
  • Vimpat




Primary Outcome Measures :
  1. Adverse events, Vital signs, electrocardiograms,Physical examination, neurological examination [ Time Frame: 2 Days ]

Secondary Outcome Measures :
  1. Seizure counts [ Time Frame: 2 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00800215


Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
Additional Information:
Publications of Results:
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Responsible Party: Study Director, UCB
ClinicalTrials.gov Identifier: NCT00800215    
Other Study ID Numbers: SP616
First Posted: December 2, 2008    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015
Keywords provided by UCB Pharma:
Epilepsy
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lacosamide
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action