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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00800215
First Posted: December 2, 2008
Last Update Posted: May 27, 2015
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.
Information provided by:
UCB Pharma
  Purpose

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 Intervention Phase
Epilepsy Drug: iv SPM 927 and oral placebo tablet Drug: oral SPM 927 tablet and iv placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

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

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

Enrollment: 60
Study Start Date: March 2004
Study Completion Date: November 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
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.
  Contacts and Locations
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
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
Publications:
Responsible Party: Study Director, UCB
ClinicalTrials.gov Identifier: NCT00800215     History of Changes
Other Study ID Numbers: SP616
First Submitted: December 1, 2008
First Posted: December 2, 2008
Last Update Posted: May 27, 2015
Last Verified: May 2015

Keywords provided by UCB Pharma:
Epilepsy

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lacosamide
Anticonvulsants