EpilepsyPhase 2NCT00800215
A Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927
A Phase 2 study of Epilepsy, run by UCB Pharma.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 4 Mar 2004to 30 Nov 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject with partial seizures with or without secondary generalization
Who cannot join
- 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.
About this 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
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.
- Conditions
- Epilepsy
- Being tested
- iv SPM 927 and oral placebo tablet, oral SPM 927 tablet and iv placebo
- Keywords
- Epilepsy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iv SPM 927 and oral placebo tabletDrug
Also called Lacosamide, Vimpat
60-minute infusion iv SPM 927 and oral placebo tablet
oral SPM 927 tablet and iv placeboDrug
Also called Lacosamide, Vimpat
60-minute infusion placebo and oral SPM 927 tablet
iv SPM 927 and oral placebo tabletDrug
Also called Lacosamide, Vimpat
30-minute infusion iv SPM 927 and oral placebo tablet
oral SPM 927 tablet and iv placeboDrug
Also called Lacosamide, Vimpat
30-minute infusion placebo and oral SPM 927 tablet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: iv SPM 927 and oral placebo tablet |
| 2 | Placebo comparator | Not described Receives: Drug: oral SPM 927 tablet and iv placebo |
| 3 | Experimental | Not described Receives: Drug: iv SPM 927 and oral placebo tablet |
| 4 | Placebo comparator | Not described Receives: Drug: oral SPM 927 tablet and iv placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events, Vital signs, electrocardiograms,Physical examination, neurological examination
Measured: 2 Days
Secondary outcomes (1)
Seizure counts
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2008 (estimated)
- Study start4 Mar 2004
- Primary completion17 Aug 2004
- Study completion30 Nov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800215
- Sponsor's protocol ID
- SP616
- Status last verified
- Apr 2024
- First submitted
- 1 Dec 2008
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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. doi: 10.1111/j.1528-1167.2007.01317.x. Epub 2007 Sep 19.
PubMed 17888078
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00800215
- Acronym / sponsor ID
- SP616
- Conditions
- Epilepsy
- Keywords
- Epilepsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2004 (actual)
- Primary completion
- 17 Aug 2004 (actual)
- Study completion
- 30 Nov 2004 (actual)
- First posted
- 2 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: iv SPM 927 and oral placebo tablet |
| 2 | Placebo comparator | Drug: oral SPM 927 tablet and iv placebo |
| 3 | Experimental | Drug: iv SPM 927 and oral placebo tablet |
| 4 | Placebo comparator | Drug: oral SPM 927 tablet and iv placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject with partial seizures with or without secondary generalization
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iv SPM 927 and oral placebo tabletAlso: Lacosamide, Vimpat60-minute infusion iv SPM 927 and oral placebo tablet | Drug | 1 |
| oral SPM 927 tablet and iv placeboAlso: Lacosamide, Vimpat60-minute infusion placebo and oral SPM 927 tablet | Drug | 2 |
| iv SPM 927 and oral placebo tabletAlso: Lacosamide, Vimpat30-minute infusion iv SPM 927 and oral placebo tablet | Drug | 3 |
| oral SPM 927 tablet and iv placeboAlso: Lacosamide, Vimpat30-minute infusion placebo and oral SPM 927 tablet | Drug | 4 |
Primary outcome
Adverse events, Vital signs, electrocardiograms,Physical examination, neurological examination
Time frame: 2 Days
1 secondary outcome
Seizure counts
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Results publication: PubMed 17888078Biton 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. doi: 10.1111/j.1528-1167.2007.01317.x. Epub 2007 Sep 19.
- Clinical Study Summary on UCB.comLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Epilepsy, run by UCB Pharma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events, Vital signs, electrocardiograms,Physical examination, neurological examination (time frame: 2 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00800215, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.