Trial Outcomes & Findings for N-Acetylcysteine for Adolescent Alcohol Use Disorder (NCT NCT03707951)
NCT ID: NCT03707951
Last Updated: 2025-01-08
Results Overview
Alcohol use (total standard drinks) during the final four weeks of treatment (Weeks 5-8), compared between NAC and placebo groups.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
126 participants
Primary outcome timeframe
Final 4 weeks of treatment
Results posted on
2025-01-08
Participant Flow
Participant milestones
| Measure |
N-acetylcysteine
N-acetylcysteine 1200 mg twice daily for 8 weeks; administered orally
N-acetylcysteine: N-acetylcysteine 1200 mg twice daily for 8 weeks (administered orally)
|
Placebo
Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 8 weeks; administered orally
Placebo oral capsule: Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 12 weeks (administered orally)
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
61
|
|
Overall Study
Completed Active Treatment
|
53
|
52
|
|
Overall Study
COMPLETED
|
51
|
38
|
|
Overall Study
NOT COMPLETED
|
14
|
23
|
Reasons for withdrawal
| Measure |
N-acetylcysteine
N-acetylcysteine 1200 mg twice daily for 8 weeks; administered orally
N-acetylcysteine: N-acetylcysteine 1200 mg twice daily for 8 weeks (administered orally)
|
Placebo
Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 8 weeks; administered orally
Placebo oral capsule: Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 12 weeks (administered orally)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
17
|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
Baseline Characteristics
N-Acetylcysteine for Adolescent Alcohol Use Disorder
Baseline characteristics by cohort
| Measure |
N-acetylcysteine
n=65 Participants
N-acetylcysteine 1200 mg twice daily for 8 weeks; administered orally
N-acetylcysteine: N-acetylcysteine 1200 mg twice daily for 8 weeks (administered orally)
|
Placebo
n=61 Participants
Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 8 weeks; administered orally
Placebo oral capsule: Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 12 weeks (administered orally)
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.1 years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
20.9 years
STANDARD_DEVIATION 2.4 • n=7 Participants
|
21.0 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
62 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
65 participants
n=5 Participants
|
61 participants
n=7 Participants
|
126 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Final 4 weeks of treatmentPopulation: Randomized participants
Alcohol use (total standard drinks) during the final four weeks of treatment (Weeks 5-8), compared between NAC and placebo groups.
Outcome measures
| Measure |
N-acetylcysteine
n=65 Participants
N-acetylcysteine 1200 mg twice daily for 8 weeks; administered orally
N-acetylcysteine: N-acetylcysteine 1200 mg twice daily for 8 weeks (administered orally)
|
Placebo
n=61 Participants
Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 8 weeks; administered orally
Placebo oral capsule: Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 12 weeks (administered orally)
|
|---|---|---|
|
Alcohol Use During the Final 4 Weeks of Treatment (Weeks 5 - 8)
|
37.9 Standard drinks
Standard Deviation 28.3
|
42.6 Standard drinks
Standard Deviation 43.1
|
Adverse Events
N-acetylcysteine
Serious events: 0 serious events
Other events: 48 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
N-acetylcysteine
n=65 participants at risk
N-acetylcysteine 1200 mg twice daily for 8 weeks; administered orally
N-acetylcysteine: N-acetylcysteine 1200 mg twice daily for 8 weeks (administered orally)
|
Placebo
n=61 participants at risk
Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 8 weeks; administered orally
Placebo oral capsule: Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 12 weeks (administered orally)
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Ear and labyrinth disorders
Otitis media
|
3.1%
2/65 • Number of events 2 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
4/65 • Number of events 4 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
4.9%
3/61 • Number of events 3 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Gastrointestinal disorders
Constipation
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 2 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Gastrointestinal disorders
Decreased appetite
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Gastrointestinal disorders
Diarrhea
|
4.6%
3/65 • Number of events 3 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Gastrointestinal disorders
Dyspepsia
|
13.8%
9/65 • Number of events 15 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Gastrointestinal disorders
Dyspepsia (worsening)
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Gastrointestinal disorders
Gastroenteritis
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
3.3%
2/61 • Number of events 2 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.7%
5/65 • Number of events 6 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
3.3%
2/61 • Number of events 2 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Gastrointestinal disorders
Nausea
|
18.5%
12/65 • Number of events 14 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
19.7%
12/61 • Number of events 16 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Gastrointestinal disorders
Regurgitation
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Gastrointestinal disorders
Salivary gland calculus
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Gastrointestinal disorders
Stomachache
|
3.1%
2/65 • Number of events 2 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Gastrointestinal disorders
Vomiting
|
4.6%
3/65 • Number of events 3 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
6.6%
4/61 • Number of events 4 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
General disorders
Dysguesia
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
General disorders
Fatigue
|
6.2%
4/65 • Number of events 4 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
3.3%
2/61 • Number of events 2 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
General disorders
Malaise
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
General disorders
Pain in jaw
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 2 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
General disorders
Pyrexia
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
General disorders
Chest pain
|
4.6%
3/65 • Number of events 3 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Infections and infestations
Laryngitis
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Infections and infestations
COVID-19
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Infections and infestations
Influenza
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
3.3%
2/61 • Number of events 2 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Infections and infestations
Influenza-like illness
|
3.1%
2/65 • Number of events 2 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Infections and infestations
Pharyngitis
|
4.6%
3/65 • Number of events 3 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Infections and infestations
Pharyngitis, streptococcal
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Infections and infestations
Sinus headache
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Infections and infestations
Tinea infection
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Infections and infestations
Tonsillitis
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
5/65 • Number of events 5 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
3.3%
2/61 • Number of events 2 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Infections and infestations
Vaginal infection
|
4.6%
3/65 • Number of events 3 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Infections and infestations
Viral upper respiratory infection
|
18.5%
12/65 • Number of events 15 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
13.1%
8/61 • Number of events 9 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Injury, poisoning and procedural complications
Accidental exposure to product
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Injury, poisoning and procedural complications
Back pain
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
1.5%
1/65 • Number of events 2 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Metabolism and nutrition disorders
Weight increased
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Musculoskeletal and connective tissue disorders
Back muscle spasms
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Musculoskeletal and connective tissue disorders
Body aches
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
3.3%
2/61 • Number of events 2 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Musculoskeletal and connective tissue disorders
Restless leg syndrome
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Nervous system disorders
Concussion
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Nervous system disorders
Dizziness
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Nervous system disorders
Headache
|
15.4%
10/65 • Number of events 12 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
18.0%
11/61 • Number of events 14 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Nervous system disorders
Hypothesia
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Nervous system disorders
Lethargy
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Nervous system disorders
Migraine
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Nervous system disorders
Paresthesias
|
4.6%
3/65 • Number of events 3 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Nervous system disorders
Sleep paralysis
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Nervous system disorders
Vivid dreams
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
3.3%
2/61 • Number of events 2 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
General disorders
Menstruation delayed
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Psychiatric disorders
Anxiety
|
3.1%
2/65 • Number of events 2 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Psychiatric disorders
Anxiety (worsening)
|
4.6%
3/65 • Number of events 3 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
3.3%
2/61 • Number of events 2 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Psychiatric disorders
Attention-Deficit/Hyperactivity Disorder
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Psychiatric disorders
Depressed mood
|
4.6%
3/65 • Number of events 3 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Psychiatric disorders
Insomnia
|
6.2%
4/65 • Number of events 6 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
11.5%
7/61 • Number of events 8 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
General disorders
Post-operative pain
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
3.1%
2/65 • Number of events 2 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Reproductive system and breast disorders
Irregular menses
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Reproductive system and breast disorders
Mastalgia
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Respiratory, thoracic and mediastinal disorders
COVID-19
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.6%
3/65 • Number of events 3 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
4.9%
3/61 • Number of events 3 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
3.3%
2/61 • Number of events 2 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Respiratory, thoracic and mediastinal disorders
Oopharyngeal pain
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Respiratory, thoracic and mediastinal disorders
Seasonal rhinitis (worsening)
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus headache
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
4.9%
3/61 • Number of events 3 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
3.1%
2/65 • Number of events 2 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
3.1%
2/65 • Number of events 2 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Skin and subcutaneous tissue disorders
Sunburn
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Surgical and medical procedures
Post-procedural complication
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Surgical and medical procedures
Post-operative pain
|
1.5%
1/65 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
0.00%
0/61 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
|
Surgical and medical procedures
Tonsillectomy/uvulectomy
|
0.00%
0/65 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
1.6%
1/61 • Number of events 1 • 6 months (from randomization to final post-treatment follow-up visit)
Adverse events were assessed and documented by the study medical clinician and entered using MedDRA terminology.
|
Additional Information
Kevin M. Gray, M.D.
Medical University of South Carolina
Phone: 843-792-6330
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place