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

This study has been completed.
Sponsor:
Information provided by:
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00800215
First received: December 1, 2008
Last updated: September 9, 2013
Last verified: February 2010
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Seizure counts [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]

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

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: December 1, 2008
Last Updated: September 9, 2013
Health Authority: Lithuania: State Medicine Control Agency - Ministry of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Lacosamide
Anticonvulsants
Central Nervous System Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014