A Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927 - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00800215

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 II

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety Study
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

Further study details as provided by UCB:

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
1: Experimental	Drug: iv SPM 927 and oral placebo tablet 60-minute infusion iv SPM 927 and oral placebo tablet
2: Placebo Comparator	Drug: oral SPM 927 tablet and iv placebo 60-minute infusion placebo and oral SPM 927 tablet
3: Experimental	Drug: iv SPM 927 and oral placebo tablet 30-minute infusion iv SPM 927 and oral placebo tablet
4: Placebo Comparator	Drug: oral SPM 927 tablet and iv placebo 30-minute infusion placebo and oral SPM 927 tablet

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00800215

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	SP616
Study First Received:	December 1, 2008
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00800215 History of Changes
Health Authority:	Lithuania: State Medicine Control Agency - Ministry of Health; United States: Food and Drug Administration

Study placed in the following topic categories:

Epilepsy
Seizures
Neoplasm Metastasis
Central Nervous System Diseases
Brain Diseases

Additional relevant MeSH terms:

Epilepsy
Nervous System Diseases
Central Nervous System Diseases
Brain Diseases

ClinicalTrials.gov processed this record on May 07, 2009