Trial Outcomes & Findings for Randomized, Controlled Trial of Extended-Release Niacin (Niaspan®) to Augment Subacute Ischemic Stroke Recovery (NCT NCT00796887)
NCT ID: NCT00796887
Last Updated: 2026-08-28
Results Overview
Analysis of the frequency and type of serious adverse events among patients in each study arm/group
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
24 weeks
Results posted on
2026-08-28
Participant Flow
Due to early termination of the study, participant enrollment in each extended-release niacin arm were lower than anticipated. T
Participant milestones
| Measure |
Niaspan 500mg
Extended-Release Niacin 500mg once daily
|
Niaspan® 1000mg
Extended-Release Niacin: 1000mg tablet once daily
|
Placebo
Placebo: Placebo tablet once daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
7
|
10
|
|
Overall Study
COMPLETED
|
10
|
6
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Niaspan 500mg
Extended-Release Niacin 500mg once daily
|
Niaspan® 1000mg
Extended-Release Niacin: 1000mg tablet once daily
|
Placebo
Placebo: Placebo tablet once daily
|
|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
1
|
Baseline Characteristics
Randomized, Controlled Trial of Extended-Release Niacin (Niaspan®) to Augment Subacute Ischemic Stroke Recovery
Baseline characteristics by cohort
| Measure |
Niaspan® 500mg
n=10 Participants
Extended-Release Niacin: 500mg tablet once daily
|
Niaspan® 1000mg
n=7 Participants
Extended-Release Niacin: 1000mg tablet once daily
|
Placebo
n=10 Participants
Placebo: Placebo tablet once daily
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=31 Participants
|
6 Participants
n=49 Participants
|
5 Participants
n=80 Participants
|
18 Participants
n=29 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=31 Participants
|
1 Participants
n=49 Participants
|
5 Participants
n=80 Participants
|
9 Participants
n=29 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=31 Participants
|
2 Participants
n=49 Participants
|
2 Participants
n=80 Participants
|
8 Participants
n=29 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=31 Participants
|
5 Participants
n=49 Participants
|
8 Participants
n=80 Participants
|
19 Participants
n=29 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=31 Participants
|
7 Participants
n=49 Participants
|
10 Participants
n=80 Participants
|
27 Participants
n=29 Participants
|
|
National Institutes of Health Stroke Scale score
|
8.8 scores on a scale
STANDARD_DEVIATION 4.4 • n=31 Participants
|
9.7 scores on a scale
STANDARD_DEVIATION 3.0 • n=49 Participants
|
10.4 scores on a scale
STANDARD_DEVIATION 6.8 • n=80 Participants
|
9.6 scores on a scale
STANDARD_DEVIATION 4.9 • n=29 Participants
|
PRIMARY outcome
Timeframe: 24 weeksAnalysis of the frequency and type of serious adverse events among patients in each study arm/group
Outcome measures
| Measure |
Niaspan® 500mg
n=10 Participants
Extended-Release Niacin: 500mg tablet once daily
|
Niaspan® 1000mg
n=7 Participants
Extended-Release Niacin:1000mg tablet once daily
|
Placebo
n=10 Participants
Placebo: Placebo tablet once daily
|
|---|---|---|---|
|
Number of Participants With Serious Adverse Events
|
2 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 24 weeksExploratory efficacy analysis of the differences in functional recovery between each study arm as measured using the National Institutes of Stroke Scale score. The National Institutes of Health Stroke Scale score is a 15-item neurological examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Ratings for each item are scored on a 3- to 5-point scale, with 0 as normal, and there is an allowance for untestable items. Scores range from 0 to 42, with higher scores indicating greater severity
Outcome measures
| Measure |
Niaspan® 500mg
n=10 Participants
Extended-Release Niacin: 500mg tablet once daily
|
Niaspan® 1000mg
n=7 Participants
Extended-Release Niacin:1000mg tablet once daily
|
Placebo
n=10 Participants
Placebo: Placebo tablet once daily
|
|---|---|---|---|
|
Functional Recovery
|
2.1 scores on a scale
Standard Deviation 2.4
|
3.7 scores on a scale
Standard Deviation 3.0
|
4.3 scores on a scale
Standard Deviation 5.4
|
Adverse Events
Niaspan® 500mg
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
Niaspan® 1000mg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Placebo
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Niaspan® 500mg
n=10 participants at risk
Extended-Release Niacin: 500mg tablet once daily
|
Niaspan® 1000mg
n=7 participants at risk
Extended-Release Niacin: 1000mg tablet once daily
|
Placebo
n=10 participants at risk
Placebo: Placebo tablet once daily
|
|---|---|---|---|
|
Cardiac disorders
Death
|
0.00%
0/10 • AE assessments were reviewed at Baseline, 4 weeks, 12 weeks and 24 weeks post enrollment.
Additional column inserted to establish 3 arms as the protocol indicates.
|
14.3%
1/7 • Number of events 1 • AE assessments were reviewed at Baseline, 4 weeks, 12 weeks and 24 weeks post enrollment.
Additional column inserted to establish 3 arms as the protocol indicates.
|
10.0%
1/10 • Number of events 1 • AE assessments were reviewed at Baseline, 4 weeks, 12 weeks and 24 weeks post enrollment.
Additional column inserted to establish 3 arms as the protocol indicates.
|
|
Nervous system disorders
Stroke
|
20.0%
2/10 • Number of events 2 • AE assessments were reviewed at Baseline, 4 weeks, 12 weeks and 24 weeks post enrollment.
Additional column inserted to establish 3 arms as the protocol indicates.
|
0.00%
0/7 • AE assessments were reviewed at Baseline, 4 weeks, 12 weeks and 24 weeks post enrollment.
Additional column inserted to establish 3 arms as the protocol indicates.
|
0.00%
0/10 • AE assessments were reviewed at Baseline, 4 weeks, 12 weeks and 24 weeks post enrollment.
Additional column inserted to establish 3 arms as the protocol indicates.
|
Other adverse events
| Measure |
Niaspan® 500mg
n=10 participants at risk
Extended-Release Niacin: 500mg tablet once daily
|
Niaspan® 1000mg
n=7 participants at risk
Extended-Release Niacin: 1000mg tablet once daily
|
Placebo
n=10 participants at risk
Placebo: Placebo tablet once daily
|
|---|---|---|---|
|
Psychiatric disorders
Other
|
20.0%
2/10 • Number of events 2 • AE assessments were reviewed at Baseline, 4 weeks, 12 weeks and 24 weeks post enrollment.
Additional column inserted to establish 3 arms as the protocol indicates.
|
14.3%
1/7 • Number of events 1 • AE assessments were reviewed at Baseline, 4 weeks, 12 weeks and 24 weeks post enrollment.
Additional column inserted to establish 3 arms as the protocol indicates.
|
0.00%
0/10 • AE assessments were reviewed at Baseline, 4 weeks, 12 weeks and 24 weeks post enrollment.
Additional column inserted to establish 3 arms as the protocol indicates.
|
|
Blood and lymphatic system disorders
Lab Level
|
10.0%
1/10 • Number of events 1 • AE assessments were reviewed at Baseline, 4 weeks, 12 weeks and 24 weeks post enrollment.
Additional column inserted to establish 3 arms as the protocol indicates.
|
14.3%
1/7 • Number of events 1 • AE assessments were reviewed at Baseline, 4 weeks, 12 weeks and 24 weeks post enrollment.
Additional column inserted to establish 3 arms as the protocol indicates.
|
10.0%
1/10 • Number of events 1 • AE assessments were reviewed at Baseline, 4 weeks, 12 weeks and 24 weeks post enrollment.
Additional column inserted to establish 3 arms as the protocol indicates.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place