Trial Outcomes & Findings for Efficacy of Centanafadine SR as a Potential Smoking Cessation Treatment (NCT NCT05066724)
NCT ID: NCT05066724
Last Updated: 2025-06-13
Results Overview
Participants were considered abstinent from combustible cigarettes if the participant self-reported tobacco abstinence (no cigarette smoking, not even a puff) assessed by responses to daily messages throughout Weeks 4-7. Any participants lost to follow-up after receiving the investigational product, or who have smoked during Weeks 4-7 were counted as non-abstinent. The binomial confidence interval was based on normal approximation. If the number of abstinent or the number of non-abstinent ≤ 5, exact method was used.
COMPLETED
PHASE2
50 participants
Weeks 4 to 7
2025-06-13
Participant Flow
Participants took part in the study at 2 investigative centers in the United States from 15 September 2021 to 31 May 2022.
A total of 287 participants were screened of which 50 participants were enrolled and treated in this study.
Participant milestones
| Measure |
Centanafadine
Participants received centanafadine sustained release (SR) tablets, orally, at a total daily dose (TDD) of 400 milligrams (mg), administered as 200 mg doses, twice daily (BID), approximately 4 to 6 hours apart, for a total of 7 weeks.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
Full Analysis Set
|
50
|
|
Overall Study
Safety Analysis Set
|
50
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Centanafadine
Participants received centanafadine sustained release (SR) tablets, orally, at a total daily dose (TDD) of 400 milligrams (mg), administered as 200 mg doses, twice daily (BID), approximately 4 to 6 hours apart, for a total of 7 weeks.
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|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Non-Compliance With Study Drug
|
5
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
Efficacy of Centanafadine SR as a Potential Smoking Cessation Treatment
Baseline characteristics by cohort
| Measure |
Centanafadine
n=50 Participants
Participants received centanafadine SR tablets, orally, at a TDD of 400 mg, administered as 200 mg doses, BID, approximately 4 to 6 hours apart, for a total of 7 weeks.
|
|---|---|
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Age, Continuous
|
45.1 years
STANDARD_DEVIATION 10.8 • n=93 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
31 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
12 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
2 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Weeks 4 to 7Population: Full Analysis Set included all participants who were administered at least one dose of IMP.
Participants were considered abstinent from combustible cigarettes if the participant self-reported tobacco abstinence (no cigarette smoking, not even a puff) assessed by responses to daily messages throughout Weeks 4-7. Any participants lost to follow-up after receiving the investigational product, or who have smoked during Weeks 4-7 were counted as non-abstinent. The binomial confidence interval was based on normal approximation. If the number of abstinent or the number of non-abstinent ≤ 5, exact method was used.
Outcome measures
| Measure |
Centanafadine
n=50 Participants
Participants received centanafadine SR tables, orally, at a TDD of 400 mg, administered as 200 mg doses, BID, approximately 4 to 6 hours apart, for a total of 7 weeks.
|
|---|---|
|
Percentage of Participants With a Continuous Smoking Abstinence Rate
|
0 percentage of participants
Interval 0.0 to 5.9
|
PRIMARY outcome
Timeframe: Weeks 4 to 7Population: Full Analysis Set included all participants who were administered at least one dose of IMP.
Participants were considered abstinent from combustible cigarettes if the participants had an exhaled CO level of less than 5 parts per million (ppm) measured using the Vitalograph Breath CO monitor. Participants with actual data that they were smoking (CO value ≥ 5 ppm or any smoking record in self-report) were counted as non-abstinent The binomial confidence interval was based on normal approximation. If the number of abstinent or the number of non-abstinent ≤ 5, exact method was used.
Outcome measures
| Measure |
Centanafadine
n=50 Participants
Participants received centanafadine SR tables, orally, at a TDD of 400 mg, administered as 200 mg doses, BID, approximately 4 to 6 hours apart, for a total of 7 weeks.
|
|---|---|
|
Percentage of Participants With Continuous Smoking Abstinence Rate Determined Based on Expired Air Carbon Monoxide (CO) Reading Assessed Using the Vitalograph Breath CO Monitor
|
2.0 percentage of participants
Interval 0.1 to 9.2
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SECONDARY outcome
Timeframe: From first dose of study drug to 7 days after receiving last dose (Up to Week 8)Population: Safety Analysis Set included all participants who were administered at least one dose of IMP, regardless of any protocol violation.
Nausea was only considered when it was a treatment-emergent adverse event (TEAE). A TEAE is defined as an adverse event (AE) which starts after start of first IMP or an AE continues from baseline of the specific corresponding duration and was serious, trial drug-related or results in death, discontinuation, interruption or reduction of IMP.
Outcome measures
| Measure |
Centanafadine
n=50 Participants
Participants received centanafadine SR tables, orally, at a TDD of 400 mg, administered as 200 mg doses, BID, approximately 4 to 6 hours apart, for a total of 7 weeks.
|
|---|---|
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Percentage of Participants With Nausea
|
12.0 percentage of participants
|
Adverse Events
Centanafadine
Serious adverse events
| Measure |
Centanafadine
n=50 participants at risk
Participants received centanafadine SR tables, orally, at a TDD of 400 mg, administered as 200 mg doses, BID, approximately 4 to 6 hours apart, for a total of 7 weeks.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Angioedema
|
2.0%
1/50 • From first dose of study drug to 7 days after receiving last dose (Up to Week 8)
The Safety Analysis Set included all participants who were administered at least one dose of IMP, regardless of any protocol violation.
|
Other adverse events
| Measure |
Centanafadine
n=50 participants at risk
Participants received centanafadine SR tables, orally, at a TDD of 400 mg, administered as 200 mg doses, BID, approximately 4 to 6 hours apart, for a total of 7 weeks.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
6.0%
3/50 • From first dose of study drug to 7 days after receiving last dose (Up to Week 8)
The Safety Analysis Set included all participants who were administered at least one dose of IMP, regardless of any protocol violation.
|
|
Gastrointestinal disorders
Constipation
|
6.0%
3/50 • From first dose of study drug to 7 days after receiving last dose (Up to Week 8)
The Safety Analysis Set included all participants who were administered at least one dose of IMP, regardless of any protocol violation.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.0%
4/50 • From first dose of study drug to 7 days after receiving last dose (Up to Week 8)
The Safety Analysis Set included all participants who were administered at least one dose of IMP, regardless of any protocol violation.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
5/50 • From first dose of study drug to 7 days after receiving last dose (Up to Week 8)
The Safety Analysis Set included all participants who were administered at least one dose of IMP, regardless of any protocol violation.
|
|
Gastrointestinal disorders
Gastritis
|
8.0%
4/50 • From first dose of study drug to 7 days after receiving last dose (Up to Week 8)
The Safety Analysis Set included all participants who were administered at least one dose of IMP, regardless of any protocol violation.
|
|
Gastrointestinal disorders
Nausea
|
12.0%
6/50 • From first dose of study drug to 7 days after receiving last dose (Up to Week 8)
The Safety Analysis Set included all participants who were administered at least one dose of IMP, regardless of any protocol violation.
|
|
General disorders
Fatigue
|
10.0%
5/50 • From first dose of study drug to 7 days after receiving last dose (Up to Week 8)
The Safety Analysis Set included all participants who were administered at least one dose of IMP, regardless of any protocol violation.
|
|
General disorders
Mucosal Dryness
|
6.0%
3/50 • From first dose of study drug to 7 days after receiving last dose (Up to Week 8)
The Safety Analysis Set included all participants who were administered at least one dose of IMP, regardless of any protocol violation.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
6.0%
3/50 • From first dose of study drug to 7 days after receiving last dose (Up to Week 8)
The Safety Analysis Set included all participants who were administered at least one dose of IMP, regardless of any protocol violation.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
18.0%
9/50 • From first dose of study drug to 7 days after receiving last dose (Up to Week 8)
The Safety Analysis Set included all participants who were administered at least one dose of IMP, regardless of any protocol violation.
|
|
Nervous system disorders
Headache
|
14.0%
7/50 • From first dose of study drug to 7 days after receiving last dose (Up to Week 8)
The Safety Analysis Set included all participants who were administered at least one dose of IMP, regardless of any protocol violation.
|
|
Psychiatric disorders
Insomnia
|
22.0%
11/50 • From first dose of study drug to 7 days after receiving last dose (Up to Week 8)
The Safety Analysis Set included all participants who were administered at least one dose of IMP, regardless of any protocol violation.
|
|
Skin and subcutaneous tissue disorders
Drug Eruption
|
14.0%
7/50 • From first dose of study drug to 7 days after receiving last dose (Up to Week 8)
The Safety Analysis Set included all participants who were administered at least one dose of IMP, regardless of any protocol violation.
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Additional Information
Global Clinical Development
Otsuka Pharmaceutical Development & Commercialization, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place