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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT02150213 |
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Date of registration:
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15/05/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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 |
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Date of first enrolment:
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August 2014 |
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Target sample size:
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59 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02150213 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Germany
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Hungary
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Italy
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Korea, Republic of
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Slovakia
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United States
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Endometrial Stromal Sarcomas
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Adrenocortical Adenoma
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Intervention(s)
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Procedure: Biopsy
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Procedure: MRI, CT or ultrasound was permitted if MRI was contraindicated
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Procedure: Sonogram
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Procedure: Dexamethasone Supression Test
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Drug: BGG492
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Primary Outcome(s)
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Incidence of Uterine Endometrial Stromal Sarcomas
[Time Frame: Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212]
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Incidence of Adrenal Cortical Adenomas
[Time Frame: Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212]
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Secondary ID(s)
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2013-003431-29
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CBGG492A2216
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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