First Add-on vs. Mono-therapy Study of Topiramate in Neuro-Surgical Patients

NCT01627860 | Completed Phase 4 Results

• 3 other identifiers: CR017248TOPMATEPY4061TOP-TWN-MA4
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to examine seizure control and tolerability of Topiramate after either transitioning from previous antiepileptic drug (AED) or adding on to previous AED.

Conditions

Epilepsy

Keywords

Epilepsy; Topiramate; Neuro-surgical patients; Nervous disorder; Seizures

Outcome Measures

Primary Outcomes (1)

• Seizure Free Rate: Percentage of Participants Who Did Not Have Any Seizure Episode Within the Last Month of the Maintenance Period (ie, Month 4).

  Month 4

Secondary Outcomes (2)

• Seizure Frequency: Percent Change of Seizure Frequency by the ANCOVA Model During the Month 4

  Baseline (4 weeks retrospective assessment prior to start of titration period) to Month 4

• Dosage Administration of Topamax During Month 4

  Month 4

Study Arms (2)

Topiramate add-on therapy

ACTIVE COMPARATOR

Drug: Topiramate add-on therapy

Topiramate monotherapy

EXPERIMENTAL

Drug: Topiramate monotherapy

Interventions

Topiramate add-on therapy DRUG

Type=range, unit=mg/day, number=25-200, form=tablet, route=oral use.

Topiramate add-on therapy

Topiramate monotherapy DRUG

Type= range, unit= mg/day, number= 25-200, form= tablet, route= oral use.

Topiramate monotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be diagnosed with seizure disorder
• Have been receiving concomitant therapy with one antiepileptic drug (AED), at stable dose prior to trial entry
• Must be dissatisfied with the current treatment

You may not qualify if:

• Have treatable cause of seizures (eg, metabolic disturbance, toxic exposure, an active infection, or neoplasm)
• Have grade IV astrocytomas, eg, Glioblastoma multiforme (GBM) or metastases with progression
• Have seizures occurring only in clustered patterns defined as numerous seizures occurring in less than 30 min
• Have had history (within past six months) of a psychiatric or mood disorder requiring electroconvulsive therapy, major tranquilizers, or monoamine oxidase inhibitors
• Have had schizophrenic or history of exhibiting psychotic symptomatology
• Inability to take medication or maintain a seizure calendar, independently or with assistance

Sponsors & Collaborators

• Johnson & Johnson Taiwan Ltd: lead

MeSH Terms

Conditions

Epilepsy; Nervous System Diseases; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

No limitations were reported in this study.

Results Point of Contact

• Title: Medical Director
• Organization: Janssen-Cilag Taiwan

886 2 23762155

Study Officials

• Janssen-Cilag Taiwan Clinical Trial

  Janssen-Cilag Taiwan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2012
• First Posted: June 26, 2012
• Study Start: February 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: October 29, 2013
• Results First Posted: May 24, 2013

Record last verified: 2013-09