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Medical Safety Follow-up Study for Patients Who Received More Than 28 Days of Total Exposure to BGG492

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ClinicalTrials.gov Identifier: NCT02150213
Recruitment Status : Completed
First Posted : May 29, 2014
Results First Posted : July 25, 2016
Last Update Posted : December 5, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
To provide medical follow-up to patients exposed to BGG492 for more than 28 days in study CBGG492A2207 (NCT 01147003) and/or CBGG492A2212 (NCT 01338805).

Condition or disease Intervention/treatment Phase
Adrenocortical Adenoma Endometrial Stromal Sarcomas Procedure: MRI, CT or ultrasound was permitted if MRI was contraindicated Procedure: Dexamethasone Supression Test Procedure: Sonogram Procedure: Biopsy Drug: BGG492 Phase 2

Detailed Description:
The purpose of the study was to provide medical follow-up to patients exposed to BGG492 for more than 28 days in study CBGG492A2207 (NCT 01147003) and/or CBGG492A2212 (NCT 01338805). Data from study CBGG492A2216 was used to support the clinical safety assessment of BGG492 regarding the observance of uterine endometrial stromal tumors and adrenal cortical adenomas at least one year after the completion of BGG492 treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Multicenter Medical Safety Follow-up Study for Patients With Partial Onset Seizures Who Received More Than 28 Days of Total Exposure to BGG492 in Studies CBGG492A2207 and/or CBGG492A2212
Study Start Date : August 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015


Arm Intervention/treatment
Experimental: BGG492
This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to > 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
Procedure: MRI, CT or ultrasound was permitted if MRI was contraindicated
MRI/CT/ultrasound of abdomen
Other Name: Magnetic Resonance Imaging Computed tomography

Procedure: Dexamethasone Supression Test
Low dose of dexamethasone is administered in the evening; the next morning, a blood sample is collected to measure cortisol

Procedure: Sonogram
Sonogram of the uterus (females only)
Other Name: Sonogram ultrasound

Procedure: Biopsy
Uterine endometrial biopsy (females only)
Other Name: Uterine Biopsy

Drug: BGG492
No study-drug was administered in this study
Other Name: Selurampanel




Primary Outcome Measures :
  1. Incidence of Adrenal Cortical Adenomas [ Time Frame: Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212 ]
    Incidence of adrenal cortical adenomas as assessed by non-contrast MRI of the abdomen (CT or ultrasound of the abdomen was permitted if MRI was contraindication)

  2. Incidence of Uterine Endometrial Stromal Sarcomas [ Time Frame: Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212 ]
    Incidence of uterine endometrial stromal sarcomas as assessed by sonogram/biopsy (females)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent had to be obtained before any assessment was performed;
  2. Patients had to be cooperative, willing to participate in the study assessments, and be able to report AEs (adverse events) themselves or have a caregiver who can record and report the events;
  3. Total exposure to BGG492 treatment in Study BGG492A2207 and/or BGG492A2212 had to have been greater than 28 days
  4. At least 1 year had to have elapsed since the patient received his or her last dose of BGG492.

Exclusion Criteria:

- There were no exclusion criteria for this study. All patients meeting the inclusion criteria were eligible to participate in the follow-up safety assessments


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02150213


Locations
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United States, Florida
Novartis Investigative Site
Tallahassee, Florida, United States, 32308
United States, Maryland
Novartis Investigative Site
Baltimore, Maryland, United States, 21287
United States, New Jersey
Novartis Investigative Site
Monroe Township, New Jersey, United States, 08831
United States, Texas
Novartis Investigative Site
Dallas, Texas, United States, 75230
Germany
Novartis Investigative Site
Bernau, Germany, 16321
Novartis Investigative Site
Bielefeld, Germany, 33617
Novartis Investigative Site
Bonn, Germany, 53105
Novartis Investigative Site
Kehl-Kork, Germany, 77694
Novartis Investigative Site
Ulm, Germany, 89081
Hungary
Novartis Investigative Site
Budapest, Hungary, H-1097
Novartis Investigative Site
Kecskemet, Hungary, 6000
Novartis Investigative Site
Szombathely, Hungary, 9700
Italy
Novartis Investigative Site
Firenze, FI, Italy, 50143
Novartis Investigative Site
Milano, MI, Italy, 20142
Korea, Republic of
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 03080
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 05505
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 06351
Slovakia
Novartis Investigative Site
Hlohovec, Slovak Republic, Slovakia, 92001
Novartis Investigative Site
Kosice, Slovak Republic, Slovakia, 041 90
Novartis Investigative Site
Banska Bystrica, Slovakia, 97517
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02150213     History of Changes
Other Study ID Numbers: CBGG492A2216
2013-003431-29 ( EudraCT Number )
First Posted: May 29, 2014    Key Record Dates
Results First Posted: July 25, 2016
Last Update Posted: December 5, 2016
Last Verified: October 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Adrenocortical Adenoma,
Endometrial Stromal sarcomas
BGG492

Additional relevant MeSH terms:
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Peripheral Nervous System Agents
Sarcoma
Adenoma
Sarcoma, Endometrial Stromal
Adrenocortical Adenoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Complex and Mixed
Endometrial Stromal Tumors
Endometrial Neoplasms
Uterine Neoplasms
Uterine Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Adrenal Cortex Neoplasms
Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Adrenal Cortex Diseases
Adrenal Gland Diseases
Endocrine System Diseases
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents