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Evaluation Phenobarbital as Adjunctive Therapy in Participants With Partial Onset Seizures

NCT01284556 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 314

Last updated 2017-11-14

No results posted yet for this study

Summary

Primary:

\- to evaluate the efficacy of phenobarbital in reducing seizure frequency.

Secondary:

* to confirm dose response relationship,
* to assess the effects on Type I seizures,
* to assess the safety of phenobarbital
* to assess the drug tolerability.

Conditions

Interventions

DRUG

Phenobarbital

tablet

DRUG

Placebo tablet

tablet

Sponsors & Collaborators

  • West-Ward Pharmaceutical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2013-01-31
Completion
2016-04-30

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01284556 on ClinicalTrials.gov