NCT00152503 is a Phase 2 clinical trial of Seletracetam (UCB44212) in Epilepsy, Partial, sponsored by UCB Pharma SA.

Who is sponsoring NCT00152503?

NCT00152503 is sponsored by UCB Pharma SA.

What drugs are being tested in NCT00152503?

Interventions in NCT00152503: Seletracetam (UCB44212).

What condition does NCT00152503 study?

NCT00152503 studies Epilepsy, Partial.

Is NCT00152503 still recruiting?

NCT00152503 is currently completed. Last updated 7 September 2023.

Are results published for NCT00152503?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-09-07 · How we verify

NCT00152503

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam

Completed Phase 2 Results posted Last updated 7 September 2023

What this trial tests

Phase 2 trial testing Seletracetam (UCB44212) in Epilepsy, Partial in 59 participants. Completed in 12 May 2006.

Timeline

31 August 2005

Primary endpoint
12 May 2006

12 May 2006

Quick facts

Lead sponsor	UCB Pharma SA
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	59
Start date	31 August 2005
Primary completion	12 May 2006
Estimated completion	12 May 2006
Sites	17 locations across Canada, United States

Drugs / interventions tested

Seletracetam (UCB44212) — full drug profile →

Conditions studied

Epilepsy, Partial — all drugs for Epilepsy, Partial →

Sponsor

UCB Pharma SA — full company profile →

Who can join

Adults 18 to 65, any sex, with Epilepsy, Partial. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period Primary · During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)

Calculated as (7-day seizure frequency during the Treatment Period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1

Visit 4 (Week 5 and 6)

Group	Value	95% CI
Seletracetam	-26.07	-49.29 – -5.88

Visit 5 (Week 7 and 8)

Group	Value	95% CI
Seletracetam	-32.05	-52.60 – -8.46

Visit 6 (Week 9 and 10)

Group	Value	95% CI
Seletracetam	-42.22	-66.67 – -25.00

Visit 7 (Week 11 and 12)

Group	Value	95% CI
Seletracetam	-31.67	-79.00 – 9.02

Up-titration (Weeks 5 to 12)

Group	Value	95% CI
Seletracetam	-34.01	-50.69 – -13.27

Visit 8 (Week 13)

Group	Value	95% CI
Seletracetam	-44.44	-74.60 – -10.00

Visit 9 (Week 14)

Group	Value	95% CI
Seletracetam	-22.22	-55.56 – 12.50

Visit 10 (Week 15)

Group	Value	95% CI
Seletracetam	-33.85	-61.79 – 35.00

Percent Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period Secondary · During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)

Calculated as (7-day seizure frequency during the Treatment Period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in seizure frequency from Baseline. The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not

Visit 4 (Week 5 and 6)

Group	Value	95% CI
Seletracetam	-26.07	-49.29 – -5.88

Visit 5 (Week 7 and 8)

Group	Value	95% CI
Seletracetam	-32.05	-52.60 – -8.46

Visit 6 (Week 9 and 10)

Group	Value	95% CI
Seletracetam	-42.22	-66.67 – -25.00

Visit 7 (Week 11 and 12)

Group	Value	95% CI
Seletracetam	-31.67	-79.00 – 9.02

Up-titration (Weeks 5 to 12)

Group	Value	95% CI
Seletracetam	-34.01	-50.69 – -13.27

Visit 8 (Week 13)

Group	Value	95% CI
Seletracetam	-44.44	-74.60 – -10.00

Visit 9 (Week 14)

Group	Value	95% CI
Seletracetam	-22.22	-55.56 – 12.50

Visit 10 (Week 15)

Group	Value	95% CI
Seletracetam	-33.85	-61.79 – 35.00

Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period Secondary · During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)

Visit 4 (Week 5 and 6)

Group	Value	95% CI
Seletracetam	-0.85	-2.92 – -0.17

Visit 5 (Week 7 and 8)

Group	Value	95% CI
Seletracetam	-1.25	-3.22 – -0.39

Visit 6 (Week 9 and 10)

Group	Value	95% CI
Seletracetam	-1.83	-3.13 – -0.68

Visit 7 (Week 11 and 12)

Group	Value	95% CI
Seletracetam	-1.31	-3.13 – 0.27

Up-titration (Weeks 5 to 12)

Group	Value	95% CI
Seletracetam	-1.36	-2.77 – -0.56

Visit 8 (Week 13)

Group	Value	95% CI
Seletracetam	-1.68	-3.63 – -0.31

Visit 9 (Week 14)

Group	Value	95% CI
Seletracetam	-1.00	-2.63 – 0.48

Visit 10 (Week 15)

Group	Value	95% CI
Seletracetam	-1.14	-3.11 – 1.38

Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period Secondary · During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)

Calculated as (7-day seizure frequency during the Treatment Period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in seizure frequency from Baseline. The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not

Visit 4 (Week 5 and 6)

Group	Value	95% CI
Seletracetam	-0.85	-2.92 – -0.17

Visit 5 (Week 7 and 8)

Group	Value	95% CI
Seletracetam	-1.25	-3.22 – -0.39

Visit 6 (Week 9 and 10)

Group	Value	95% CI
Seletracetam	-1.83	-3.13 – -0.68

Visit 7 (Week 11 and 12)

Group	Value	95% CI
Seletracetam	-1.31	-3.13 – 0.27

Up-titration (Weeks 5 to 12)

Group	Value	95% CI
Seletracetam	-1.36	-2.77 – -0.56

Visit 8 (Week 13)

Group	Value	95% CI
Seletracetam	-1.68	-3.63 – -0.31

Visit 9 (Week 14)

Group	Value	95% CI
Seletracetam	-1.00	-2.63 – 0.48

Visit 10 (Week 15)

Group	Value	95% CI
Seletracetam	-1.14	-3.11 – 1.38

Seizure Frequency Per Week (Type I) by Visit Over the Treatment Period and Overall by Period Secondary · During the Treatment Period (Week 5 to Week 15)

Calculated as 7-day partial onset seizure (type I) frequency; The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.

Baseline (Week 1 to Week 4)

Group	Value	95% CI
Seletracetam	3.63	2.42 – 7.50

Visit 4 (Week 5 and 6)

Group	Value	95% CI
Seletracetam	3.25	1.57 – 5.96

Visit 5 (Week 7 and 8)

Group	Value	95% CI
Seletracetam	2.90	1.50 – 5.19

Visit 6 (Week 9 and 10)

Group	Value	95% CI
Seletracetam	2.15	1.08 – 8.40

Visit 7 (Week 11 and 12)

Group	Value	95% CI
Seletracetam	2.27	0.74 – 5.67

Up-titration (Weeks 5 to 12)

Group	Value	95% CI
Seletracetam	2.71	1.56 – 6.40

Visit 8 (Week 13)

Group	Value	95% CI
Seletracetam	2.63	1.00 – 5.00

Visit 9 (Week 14)

Group	Value	95% CI
Seletracetam	3.00	1.17 – 9.00

Seizure Frequency Per Week (Type I+II+III) by Visit Over the Treatment Period and Overall by Period Secondary · During the Treatment Period (Week 5 to Week 15)

Calculated as 7-day seizure frequency for all seizure types (type I+II+III). The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.

Baseline (Week 1 to Week 4)

Group	Value	95% CI
Seletracetam	3.63	2.42 – 7.50

Visit 4 (Week 5 and 6)

Group	Value	95% CI
Seletracetam	3.25	1.57 – 5.96

Visit 5 (Week 7 and 8)

Group	Value	95% CI
Seletracetam	2.90	1.50 – 5.19

Visit 6 (Week 9 and 10)

Group	Value	95% CI
Seletracetam	2.15	1.08 – 8.40

Visit 7 (Week 11 and 12)

Group	Value	95% CI
Seletracetam	2.27	0.74 – 5.67

Up-titration (Weeks 5 to 12)

Group	Value	95% CI
Seletracetam	2.71	1.56 – 6.40

Visit 8 (Week 13)

Group	Value	95% CI
Seletracetam	2.63	1.00 – 5.00

Visit 9 (Week 14)

Group	Value	95% CI
Seletracetam	3.00	1.17 – 9.00

Percentage of Responder Subjects in Partial Onset Seizures (Type I) Over the Up-titration Period Secondary · During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)

A responder was defined as a subject with a \>= 50% reduction in seizure frequency per week from the Baseline Period (Week 1 to Week 4) to the end of the Up-Titration Period.

Group	Value	95% CI
Seletracetam	28.6

Categorized Percentage Response to Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period Secondary · During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)

Response to treatment in partial onset seizures (type I) over the up-titration period were analyzed by the percentage change from baseline (Week 1 to Week 4) in partial seizure frequency per week over the up-titration period, grouped in 4 categories: \<-25%, -25% to \<25%, 25% to \<75%, and 75% to 100%.

< -25%

Group	Value	95% CI
Seletracetam	12.5

-25% to < 25%

Group	Value	95% CI
Seletracetam	25.0

25% to < 75%

Group	Value	95% CI
Seletracetam	57.1

75% to <100%

Group	Value	95% CI
Seletracetam	5.4

Percent Change From Baseline in Seizure-free Days Per Week Over the Up-titration Period Secondary · During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)

A day was considered seizure-free, if no seizure was reported during 24 hours. A positive value indicates improvement from Baseline (Week 1 to Week 4).

Group	Value	95% CI
Seletracetam	11.45	1.45 – 28.99

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from Baseline to Follow-Up visit (up to Week 17).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Seletracetam

Serious: 2/59 (3%)

Deaths: 0/59

Serious adverse events (3 terms)

Reaction	System	Seletracetam
Angina unstable	Cardiac disorders	—
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Convulsion	Nervous system disorders	—

Other adverse events (21 terms — click to expand)

Reaction	System	Seletracetam
Dizziness	Nervous system disorders	—
Nausea	Gastrointestinal disorders	—
Headache	Nervous system disorders	—
Fatigue	General disorders	—
Somnolence	Nervous system disorders	—
Nasopharyngitis	Infections and infestations	—
Vomiting	Gastrointestinal disorders	—
Upper respiratory tract infection	Infections and infestations	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Abdominal pain upper	Gastrointestinal disorders	—
Diarrhoea	Gastrointestinal disorders	—
Nystagmus	Nervous system disorders	—
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	—
Irritability	General disorders	—
Bronchitis	Infections and infestations	—
Herpes simplex	Infections and infestations	—
Decreased appetite	Metabolism and nutrition disorders	—
Convulsion	Nervous system disorders	—
Tremor	Nervous system disorders	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—
Sinus congestion	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: Angina unstable, Skin cancer, Convulsion.

Data from ClinicalTrials.gov NCT00152503 adverse events section.

Sponsor's own description

This trial will evaluate the efficacy and safety of UCB44212 as add-on therapy in subjects with focal epilepsy.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Intranasal Seletracetam in a Patient with Reading Epilepsy: First-in-Human Use to Prevent Reflex Seizures.
Koepp MJ, Poppert KN, Felder T, Thomschewski A, et al · · 2026 · cited 1× · PMID 41459805 · DOI 10.1002/ana.78128
Pharmacodynamic interactions between seletracetam and antiseizure comedications in the human photosensitivity model.
Löscher W, Stockis A, Klein P, Kasteleijn-Nolst Trenité D. · · 2025 · cited 1× · PMID 40261588 · DOI 10.1111/epi.18420
Seletracetam Revisited: A Missed Opportunity for Effective Epilepsy Therapy.
Löscher W, Rundfeldt C, Trinka E, Koepp M, et al · · 2026 · PMID 41774409 · DOI 10.1007/s40263-026-01281-0

Verify or expand the search:

Other UCB Pharma SA trials

Trials by the same sponsor.

NCT01832038 — Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With · Phase 3 · completed
NCT01364597 — Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy · Phase 3 · completed
NCT00345800 — Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes · Phase 1 · completed
NCT00150813 — Monotherapy With Levetiracetam in Patients Suffering From Epilepsy. · Phase 3 · completed
NCT00152464 — Prevention of Asthma With Levocetirizine 18 Month Treatment in Infants (12 - 24 Months) Suffering From Eczema (Atopic De · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00152503 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by UCB Pharma SA
Last refreshed: 7 September 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00152503.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT00152503

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (3 terms)

Sponsor's own description

Publications & conference data

Related trials

Other UCB Pharma SA trials

Verify against primary sources