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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04686786




Registration number
NCT04686786
Ethics application status
Date submitted
23/12/2020
Date registered
29/12/2020

Titles & IDs
Public title
An Open-label Extension Trial of CVL-865 as Adjunctive Therapy in the Treatment of Focal Onset Seizures
Scientific title
A 57-Week, Multicenter, Active-treatment, Open-label Extension Trial of CVL-865 as Adjunctive Therapy in Adults With Drug-Resistant Focal Onset Seizures
Secondary ID [1] 0 0
2019-004057-83
Secondary ID [2] 0 0
CVL-865-SZ-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Seizures 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CVL-865

Experimental: CVL-865 25 mg - Participants will receive CVL-865 tablets orally twice daily (BID) up to the maximum dose of 25 milligrams (mg) until Week 57 during the treatment period.


Treatment: Drugs: CVL-865
Participants will receive 25 mg CVL-865 tablets orally BID during the treatment period. The dose may be decreased to 17.5 mg BID for tolerability.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment Emergent Adverse Event (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Assessment method [1] 0 0
TEAEs will include abuse-related adverse events (AEs) and AEs related to medication handling irregularities (MHIs). The number of Participants With TEAEs and TESAEs will be assessed.
Timepoint [1] 0 0
From first dose of study drug up to Week 61 (follow up period)
Primary outcome [2] 0 0
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECGs)
Assessment method [2] 0 0
12-lead ECGs recordings will be obtained after the participant has been supine and at rest for at least 5 minutes.
Timepoint [2] 0 0
Baseline up to Week 57 or early termination (ET)
Primary outcome [3] 0 0
Number of Participants with Clinically Significant Changes in Vital Sign Measurements
Assessment method [3] 0 0
Vital signs will be measured with the participant in a sitting/semi-recumbent position after 5 minutes rest and will include temperature, systolic and diastolic blood pressure, and heart rate.
Timepoint [3] 0 0
Baseline up to Week 57 or early termination (ET)
Primary outcome [4] 0 0
Number of Participants with Clinically Significant Changes in Physical and Neurological Examination Results
Assessment method [4] 0 0
Number of participants with clinically significant changes in physical and neurological examination results will be assessed.
Timepoint [4] 0 0
Baseline up to Week 57 or early termination (ET)
Primary outcome [5] 0 0
Number of Participants With Positive Response to Columbia Suicide-Severity Rating Scale (C-SSRS)
Assessment method [5] 0 0
The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).
Timepoint [5] 0 0
Baseline up to Week 61 (follow up period)
Primary outcome [6] 0 0
Number of Participants with Positive Response to Modified Clinical Institute Withdrawal Assessment - Benzodiazepines (mCIWA-B)
Assessment method [6] 0 0
The modified Clinical Institute Withdrawal Assessment - Benzodiazepines (mCIWA-B) is a sensitive instrument to measure withdrawal under conditions where there is a taper of medication (rather than abrupt discontinuation). It consists of 17-items that monitor the type and severity of BZD withdrawal symptoms such as irritability, fatigue, appetite, and sleeplessness. The total score ranges from 1 to 68 with higher scores indicating more severe withdrawal.
Timepoint [6] 0 0
Week 54 up to Week 61

Eligibility
Key inclusion criteria
* Participants who completed treatment in Trial CVL-865-SZ-001 (NCT04244175)
* A female participant of childbearing potential who is sexually active with a nonsterilized male partner must agree to use a highly effective method of contraception from signing of informed consent through 30 days post last dose
* A male participant with a pregnant or a nonpregnant partner of childbearing potential must agree to use a condom during treatment and until the end of relevant systemic exposure in the male participant for 94 days following the last dose with the investigational medicinal product (IMP)
* Participants who are capable of giving signed informed consent
* Participants who are able, in the opinion of the investigator, to understand the nature of the trial and comply with protocol requirements, including the prescribed dosage regimens, scheduled visits, laboratory tests, and other trial procedures
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants who, in the opinion of the investigator, medical monitor, or sponsor, should not participate in the trial
* Participants who, in the judgment of the investigator, experienced poor tolerability to the IMP during the double-blind trial or whose safety assessments resulted in new concerns that would suggest that the participant may not be appropriate for 57 weeks of treatment with CVL-865 in an extension trial
* Participants who experienced status epilepticus during Trial CVL-865-SZ-001
* Participants who have demonstrated substantial noncompliance to trial procedures in Trial CVL-865-SZ-001, based on the investigator's judgment, would not be eligible for this trial
* Participants who answer "yes" on the C-SSRS Suicidal Ideation Item 4 or Item 5 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan, or Active Suicidal Ideation with Specific Plan and Intent), or participants who answer "yes" on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior), or participants who, in the opinion of the investigator, present a serious risk of suicide
* Participants with any of the following abnormalities in clinical laboratory tests at Visit 1, as assessed by the central laboratory and confirmed by a single repeat measurement, if deemed necessary (Females: Hemoglobin <11 gram per deciliter (g/dL); Males: hemoglobin <12 g/dL; White blood cell (WBC) count <3.0 x 10 power 9 per liter (10^9/L); Neutrophil count <2.0 x 10^9/L; Platelet count <150 × 10^9/L)
* Participants who would be likely to require the use of prohibited concomitant medications during the trial
* Female participants who have a positive pregnancy test result

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/12/2024
Sample size
Target
Accrual to date
Final
105
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Camperdown, New South Wales - Camperdown
Recruitment hospital [2] 0 0
Randwick, New South Wales - Randwick
Recruitment hospital [3] 0 0
Westmead, New South Wales - Westmead
Recruitment hospital [4] 0 0
Herston, Queensland - Herston
Recruitment hospital [5] 0 0
Fitzroy, Victoria - Fitzroy
Recruitment hospital [6] 0 0
Heidelberg, Victoria - Heidelberg
Recruitment hospital [7] 0 0
Melbourne, Victoria - Melbourne
Recruitment hospital [8] 0 0
Parkville, Victoria - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment postcode(s) [8] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Hawaii
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Maine
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Oklahoma
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
South Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Utah
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Seoul
Country [19] 0 0
Poland
State/province [19] 0 0
Kujawsko-Pomorskie
Country [20] 0 0
Poland
State/province [20] 0 0
Lodz
Country [21] 0 0
Poland
State/province [21] 0 0
Malopolskie
Country [22] 0 0
Poland
State/province [22] 0 0
Pomorskie
Country [23] 0 0
Poland
State/province [23] 0 0
Wojnicz Lskie
Country [24] 0 0
Poland
State/province [24] 0 0
Bialystok
Country [25] 0 0
Poland
State/province [25] 0 0
Warszawa
Country [26] 0 0
Serbia
State/province [26] 0 0
Sumadija
Country [27] 0 0
Spain
State/province [27] 0 0
Andalusia
Country [28] 0 0
Spain
State/province [28] 0 0
Catalonia
Country [29] 0 0
Spain
State/province [29] 0 0
Madrid
Country [30] 0 0
Spain
State/province [30] 0 0
Sevilla
Country [31] 0 0
Spain
State/province [31] 0 0
Valencia
Country [32] 0 0
Ukraine
State/province [32] 0 0
Uzhgorod
Country [33] 0 0
Ukraine
State/province [33] 0 0
Kyiv
Country [34] 0 0
Ukraine
State/province [34] 0 0
Lviv

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04686786