Open-label Extension to Protocol 1042-0600

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marinus Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00512317
First received: August 3, 2007
Last updated: October 14, 2013
Last verified: October 2013
  Purpose

To allow open-label extension to patients who have completed Protocol 1042-0600.


Condition Intervention Phase
Epilepsies, Partial
Drug: ganaxolone
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Extension Study to Evaluate the Safety, Tolerability, and Efficacy of Ganaxolone as add-on Therapy in Adult Patients With Epilepsy Consisting of Uncontrolled Partial-onset Seizures.

Resource links provided by NLM:


Further study details as provided by Marinus Pharmaceuticals:

Primary Outcome Measures:
  • Change in weekly seizure frequency (including POS with or without secondary generalization, but not non-motor SPS)at study end compared to baseline at beginning of the double-blind study (1042-0600) [ Time Frame: 26-32 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Responder rate. Responder is defined as patients experiencing ≥50% of reduction in weekly seizure frequency at study end from the baseline [ Time Frame: 26-32 weeks ] [ Designated as safety issue: No ]
  • Number of seizure-free subjects and seizure-free rate [ Time Frame: 26-32 weeks ] [ Designated as safety issue: No ]
  • The weekly seizure frequencies for each seizure subtype: POS with or without secondary generalization, but not non-motor SPS [ Time Frame: 26-32 weeks ] [ Designated as safety issue: No ]
  • Seizure severity and quality of life surveys [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Change in rate of seizures in catamenial epilepsy [ Time Frame: 26-32 weeks ] [ Designated as safety issue: No ]

Enrollment: 125
Study Start Date: June 2007
Study Completion Date: September 2013
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ganaxolone
active experimental drug
Drug: ganaxolone
liquid suspension dosed tid

Detailed Description:

This is an open-label study evaluating efficacy and safety of ganaxolone treatment in adults with partial onset epilepsy with or without secondary generalizations.

The study consists of 13 visits over 108 (+or-2) weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects who have completed all scheduled clinical study visits in the previous protocol 1042-0600 and have been deemed eligible (no major adverse events thought to be drug related) by the Investigator.
  2. Diagnosis of epilepsy with CPS with or without secondarily generalized seizures according to the International League Against Epilepsy [ILAE] Classification of Epileptic Seizures (1981). Diagnosis should have been established by clinical history and computerized tomography (CT) or magnetic resonance imaging (MRI) of the brain to rule out progressive structural lesions and electroencephalogram (EEG) or video EEG with results consistent with partial-onset epilepsy.
  3. Male or female, 18 to 69 years of age (inclusive). [Note: Subjects who are > 69 years of age but are of good health condition may be allowed to enter the study after discussion with and approval by the Medical Monitor.]
  4. A 12-lead electrocardiogram (ECG) without clinically significant abnormalities.
  5. Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study.
  6. Able to participate for the full term of study.
  7. Able to keep a seizure diary throughout the course of the study.
  8. Sexually active women of childbearing potential must be using a medically acceptable method of birth control and have a negative qualitative serum beta-human chorionic growth hormone (beta HCG) pregnancy test result from a blood sample collected at the initial screening visit. A woman of childbearing potential is defined as a female who is biologically capable of becoming pregnant. A medically acceptable method of birth control includes intrauterine devices in place for at least 3 months, surgical sterilization, or adequate barrier methods (e.g., diaphragm and foam). An oral contraceptive alone is not considered adequate for the purpose of this study. Use of oral contraceptives in combination with another method (e.g., a spermicidal cream) is acceptable. In subjects who are not sexually active, abstinence is an acceptable form of birth control and qualitative serum βHCG pregnancy tests must be tested per protocol.
  9. Subjects with a history of depression must be stable and may be taking one antidepressant medication

Exclusion Criteria

  1. Presence of non-motor simple partial seizures only.
  2. History of pseudoseizures in the last 5 years.
  3. History of a primary generalized seizure in the last 5 years.
  4. Past use of vigabatrin without stable visual fields tested twice over the 12 months after the last dose of vigabatrin (Concomitant use of vigabatrin is not allowed).
  5. Seizures secondary to illicit drug or alcohol use, infection, neoplasm, demyelinating disease, degenerative neurological disease, or CNS disease deemed progressive, metabolic illness, or progressive degenerative disease.
  6. Status epilepticus within the last year prior to randomization in1042-0600 study.
  7. Clinically unstable psychiatric disorder within the last 2 years.
  8. Suicide attempt within the last 5 years or current significant suicidal ideation.
  9. History of psychosis within the last 5 years.
  10. Current use of neuroleptics for psychosis.
  11. A significant medical or surgical condition at screening which might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, or hepatic systems or other conditions that would place the subject at increased risk.
  12. Known sensitivity or allergy to progesterone or related steroid compounds.
  13. History of drug use or alcohol abuse within the past 5 years.
  14. Sexually active women of childbearing potential (WCBP) who are unwilling to use a double-barrier method and establish that they are currently not pregnant by submitting to a serum pregnancy test.
  15. A history of chronic noncompliance with drug regimens.
  16. Females who are currently breastfeeding.
  17. Exposure to any other investigational drug within 30 days prior to randomization in 1042-0600 study.
  18. Aspartate transaminase (AST) or alanine transaminase (ALT) levels > 3 times the upper limit of normal (ULN) at screening.
  19. Subject has history of repetitive seizures within the 12-month period preceding study entry where the individual seizures cannot be counted.
  20. Inability to withhold grapefruit and grapefruit juice from diet during the entire clinical trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00512317

  Show 25 Study Locations
Sponsors and Collaborators
Marinus Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Marinus Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00512317     History of Changes
Other Study ID Numbers: 1042-0601, V1.6
Study First Received: August 3, 2007
Last Updated: October 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Marinus Pharmaceuticals:
partial onset epilepsy
adult epilepsy
partial seizures
anticonvulsant
catamenial epilepsy
adult partial onset epilepsy

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 22, 2014