Trial Outcomes & Findings for Effect of Oral Cimetidine in the Protoporphyrias (NCT NCT05020184)
NCT ID: NCT05020184
Last Updated: 2026-06-29
Results Overview
Percent change in erythrocyte total protoporphyrin levels after treatment period versus before.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Before and after each 3-month treatment period
Results posted on
2026-06-29
Participant Flow
A total of 26 patients signed the consent form and were therefore considered enrolled. 25 patients were assigned a randomization group.
Participant milestones
| Measure |
Placebo/ Cimetidine
Subjects in this arm were randomized to receive placebo during the first treatment period and cimetidine during the second treatment period.
|
Cimetidine/ Placebo
Subjects in this arm were randomized to receive cimetidine during the first treatment period and placebo during the second.
|
|---|---|---|
|
Treatment Period 1 (3 months)
STARTED
|
12
|
13
|
|
Treatment Period 1 (3 months)
COMPLETED
|
11
|
11
|
|
Treatment Period 1 (3 months)
NOT COMPLETED
|
1
|
2
|
|
Washout period (3 months)
STARTED
|
11
|
11
|
|
Washout period (3 months)
COMPLETED
|
11
|
11
|
|
Washout period (3 months)
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 2 (3 months)
STARTED
|
11
|
11
|
|
Treatment Period 2 (3 months)
COMPLETED
|
11
|
11
|
|
Treatment Period 2 (3 months)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Oral Cimetidine in the Protoporphyrias
Baseline characteristics by cohort
| Measure |
Placebo/ Cimetidine
n=12 Participants
Subjects in this arm were randomized to receive the Placebo during the first treatment period of the study and Cimetidine during the second treatment period of the study.
|
Cimetidine/ Placebo
n=13 Participants
Subjects in this arm were randomized to receive the Cimetidine during the first treatment period of the study and Placebo during the second treatment period of the study.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.8 Years
STANDARD_DEVIATION 19.4 • n=9 Participants
|
53.2 Years
STANDARD_DEVIATION 13.6 • n=27 Participants
|
49.1 Years
STANDARD_DEVIATION 16.9 • n=267 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
13 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
12 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=9 Participants
|
13 Participants
n=27 Participants
|
25 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=9 Participants
|
10 Participants
n=27 Participants
|
22 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=9 Participants
|
13 Participants
n=27 Participants
|
25 Participants
n=267 Participants
|
|
Study Site
MGH
|
12 Participants
n=9 Participants
|
12 Participants
n=27 Participants
|
24 Participants
n=267 Participants
|
|
Study Site
UTMB
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: Before and after each 3-month treatment periodPopulation: All participants who received at least one dose of each intervention and completed all study visits were included in the efficacy analysis.
Percent change in erythrocyte total protoporphyrin levels after treatment period versus before.
Outcome measures
| Measure |
Placebo
n=22 Participants
Oral placebo capsule twice daily
|
Cimetidine
n=22 Participants
Oral cimetidine 800mg capsule twice daily
|
|---|---|---|
|
Percent Change in Erythrocyte Total Protoporphyrin Level
|
5.24 Percent change
Interval -6.93 to 17.4
|
10.19 Percent change
Interval -4.26 to 24.64
|
SECONDARY outcome
Timeframe: Last 2 months of each treatment periodPopulation: All participants who received at least one dose of each intervention and completed all study visits were included in the efficacy analysis.
Mean daily self-reported outdoor time, in minutes, before EPP/XLP prodrome onset during the last two months of each treatment period, including days without symptoms.
Outcome measures
| Measure |
Placebo
n=22 Participants
Oral placebo capsule twice daily
|
Cimetidine
n=22 Participants
Oral cimetidine 800mg capsule twice daily
|
|---|---|---|
|
Time to Prodrome
|
93.89 Minutes per day
Interval 72.33 to 115.45
|
107.21 Minutes per day
Interval 85.07 to 129.34
|
SECONDARY outcome
Timeframe: Immediately before and at the end of the 3-month cimetidine treatment period, and immediately before and at the end of the 3-month placebo treatment periodPopulation: All participants who received at least one dose of each intervention and completed all study visits were included in the efficacy analysis.
PROMIS-57 v2 assesses 7 health domains: Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, and Pain Interference. Domain scores are converted to standardized T-scores with a U.S. general population mean of 50 and standard deviation of 10. Higher scores indicate worse outcomes for Anxiety, Depression, Fatigue, Sleep Disturbance, and Pain Interference, and better outcomes for Physical Function and Ability to Participate in Social Roles and Activities. PROMIS-57 v2 was administered immediately before and at the end of each 3-month treatment period. End-of-period PROMIS-57 v2 domain T-scores were analyzed using mixed-effects linear models adjusted for the immediately pre-treatment PROMIS-57 v2 domain T-score for that treatment period, with treatment as a fixed effect and participant as a random effect. Reported values represent least squared means for change in T-score for the cimetidine and placebo treatment periods.
Outcome measures
| Measure |
Placebo
n=22 Participants
Oral placebo capsule twice daily
|
Cimetidine
n=22 Participants
Oral cimetidine 800mg capsule twice daily
|
|---|---|---|
|
Change in PROMIS-57 v2 Domain T-scores From Pre-treatment to End of Each 3-month Treatment Period
PROMIS-57 Fatigue Score Change
|
-1.46 T-score change
95% Confidence Interval 1.9310 • Interval -3.93 to 1.01
|
0.61 T-score change
95% Confidence Interval 1.9310 • Interval -1.86 to 3.08
|
|
Change in PROMIS-57 v2 Domain T-scores From Pre-treatment to End of Each 3-month Treatment Period
PROMIS-57 Anxiety Score Change
|
-2.61 T-score change
95% Confidence Interval 1.65 • Interval -5.97 to 0.75
|
-1.33 T-score change
95% Confidence Interval 1.65 • Interval -4.68 to 2.03
|
|
Change in PROMIS-57 v2 Domain T-scores From Pre-treatment to End of Each 3-month Treatment Period
PROMIS-57 Ability to Participate in Social Roles and Activities Score Change
|
3.41 T-score change
95% Confidence Interval 2.02 • Interval -0.14 to 6.96
|
5.55 T-score change
95% Confidence Interval 2.02 • Interval 2.0 to 9.1
|
|
Change in PROMIS-57 v2 Domain T-scores From Pre-treatment to End of Each 3-month Treatment Period
PROMIS-57 Sleep Disturbance Score Change
|
0.06 T-score change
95% Confidence Interval 1.31 • Interval -3.12 to 3.25
|
0.8 T-score change
95% Confidence Interval 1.31 • Interval -2.38 to 3.98
|
|
Change in PROMIS-57 v2 Domain T-scores From Pre-treatment to End of Each 3-month Treatment Period
PROMIS-57 Physical Function Score Change
|
0.70 T-score change
95% Confidence Interval 1.60 • Interval -1.47 to 2.88
|
2.33 T-score change
95% Confidence Interval 1.60 • Interval 0.16 to 4.5
|
|
Change in PROMIS-57 v2 Domain T-scores From Pre-treatment to End of Each 3-month Treatment Period
PROMIS-57 Depression Score Change
|
-0.28 T-score change
Interval -2.68 to 2.12
|
1.81 T-score change
Interval -0.59 to 4.21
|
|
Change in PROMIS-57 v2 Domain T-scores From Pre-treatment to End of Each 3-month Treatment Period
PROMIS-57 Pain Interference Score Change
|
0.64 T-score change
95% Confidence Interval 1.63 • Interval -4.01 to 5.3
|
-3.56 T-score change
95% Confidence Interval 1.63 • Interval -8.21 to 1.1
|
SECONDARY outcome
Timeframe: Immediately before and at the end of the 3-month cimetidine treatment period, and immediately before and at the end of the 3-month placebo treatment periodPopulation: All participants who received at least one dose of each intervention and completed all study visits were included in the efficacy analysis.
PROMIS-57 v2 Pain Intensity is a single item scored from 0 to 10, with higher scores indicating worse pain intensity. The instrument-defined possible score range is 0 to 10. This question was administered immediately before and at the end of each 3-month treatment period in this crossover trial. End-of-period PROMIS-57 v2 Pain Intensity scores were analyzed using mixed-effects linear models adjusted for the immediately pre-treatment Pain Intensity score for that treatment period, with treatment as a fixed effect and participant as a random effect. Reported values represent least squared means for change in Pain Intensity scores for the cimetidine and placebo treatment periods.
Outcome measures
| Measure |
Placebo
n=22 Participants
Oral placebo capsule twice daily
|
Cimetidine
n=22 Participants
Oral cimetidine 800mg capsule twice daily
|
|---|---|---|
|
Change in PROMIS-57 v2 Pain Intensity Scores From Pre-treatment to End of Each 3-month Treatment Period
|
-0.27 Score on a scale change
Interval -1.19 to 0.64
|
-1.27 Score on a scale change
Interval -2.19 to -0.36
|
SECONDARY outcome
Timeframe: Last 2 months of the 3-month cimetidine treatment period and last 2 months of the 3-month placebo treatment periodPopulation: All participants who received at least one dose of each intervention and completed all study visits were included in the efficacy analysis.
For each participant, the number of phototoxic reactions during the last 2 months of each 3-month treatment period was recorded. In this crossover trial, the reported outcome compares the number of phototoxic reactions per patient during cimetidine with the number during placebo.
Outcome measures
| Measure |
Placebo
n=22 Participants
Oral placebo capsule twice daily
|
Cimetidine
n=22 Participants
Oral cimetidine 800mg capsule twice daily
|
|---|---|---|
|
Number of Phototoxic Reactions Per Participant During the Last 2 Months of Each Treatment Period
|
2.0 phototoxic episodes per patient
Standard Deviation 1.6
|
1.8 phototoxic episodes per patient
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Last 2 months of each treatment periodPopulation: All participants who received at least one dose of each intervention and completed all study visits were included in the efficacy analysis.
Average daily outdoor blue light dose before EPP/XLP prodrome onset during the last two months of each treatment period, including days without symptoms. Dose data for the day were excluded if the patient did not wear the dosimeter for the entire day.
Outcome measures
| Measure |
Placebo
n=22 Participants
Oral placebo capsule twice daily
|
Cimetidine
n=22 Participants
Oral cimetidine 800mg capsule twice daily
|
|---|---|---|
|
Blue Light Dose
|
6063.10 mJ/cm^2/day
Interval 4017.57 to 8108.64
|
5985.22 mJ/cm^2/day
Interval 3502.59 to 8467.85
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Washout Period
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cimetidine
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=23 participants at risk
Oral placebo capsule twice daily
|
Washout Period
n=22 participants at risk
Three month washout period between Treatment Period 1 and Treatment Period 2
|
Cimetidine
n=24 participants at risk
Oral cimetidine 800mg capsule twice daily
|
|---|---|---|---|
|
Renal and urinary disorders
Urinary tract infection
|
4.3%
1/23 • Throughout the duration of the study; the study duration was approximately 9.5 months per participant
AE analyses included all participants who were randomized and received IP. Twenty-six participants provided informed consent, 25 were randomized, and 3 discontinued during the first month of the first treatment period. One discontinued before randomization. No AEs were reported among the 4 participants who discontinued. AEs during treatment periods were assessed systematically with monthly surveys and phone calls. During the washout period, AEs were recorded when participants reported them.
|
0.00%
0/22 • Throughout the duration of the study; the study duration was approximately 9.5 months per participant
AE analyses included all participants who were randomized and received IP. Twenty-six participants provided informed consent, 25 were randomized, and 3 discontinued during the first month of the first treatment period. One discontinued before randomization. No AEs were reported among the 4 participants who discontinued. AEs during treatment periods were assessed systematically with monthly surveys and phone calls. During the washout period, AEs were recorded when participants reported them.
|
0.00%
0/24 • Throughout the duration of the study; the study duration was approximately 9.5 months per participant
AE analyses included all participants who were randomized and received IP. Twenty-six participants provided informed consent, 25 were randomized, and 3 discontinued during the first month of the first treatment period. One discontinued before randomization. No AEs were reported among the 4 participants who discontinued. AEs during treatment periods were assessed systematically with monthly surveys and phone calls. During the washout period, AEs were recorded when participants reported them.
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/23 • Throughout the duration of the study; the study duration was approximately 9.5 months per participant
AE analyses included all participants who were randomized and received IP. Twenty-six participants provided informed consent, 25 were randomized, and 3 discontinued during the first month of the first treatment period. One discontinued before randomization. No AEs were reported among the 4 participants who discontinued. AEs during treatment periods were assessed systematically with monthly surveys and phone calls. During the washout period, AEs were recorded when participants reported them.
|
0.00%
0/22 • Throughout the duration of the study; the study duration was approximately 9.5 months per participant
AE analyses included all participants who were randomized and received IP. Twenty-six participants provided informed consent, 25 were randomized, and 3 discontinued during the first month of the first treatment period. One discontinued before randomization. No AEs were reported among the 4 participants who discontinued. AEs during treatment periods were assessed systematically with monthly surveys and phone calls. During the washout period, AEs were recorded when participants reported them.
|
4.2%
1/24 • Throughout the duration of the study; the study duration was approximately 9.5 months per participant
AE analyses included all participants who were randomized and received IP. Twenty-six participants provided informed consent, 25 were randomized, and 3 discontinued during the first month of the first treatment period. One discontinued before randomization. No AEs were reported among the 4 participants who discontinued. AEs during treatment periods were assessed systematically with monthly surveys and phone calls. During the washout period, AEs were recorded when participants reported them.
|
Other adverse events
| Measure |
Placebo
n=23 participants at risk
Oral placebo capsule twice daily
|
Washout Period
n=22 participants at risk
Three month washout period between Treatment Period 1 and Treatment Period 2
|
Cimetidine
n=24 participants at risk
Oral cimetidine 800mg capsule twice daily
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
8.7%
2/23 • Throughout the duration of the study; the study duration was approximately 9.5 months per participant
AE analyses included all participants who were randomized and received IP. Twenty-six participants provided informed consent, 25 were randomized, and 3 discontinued during the first month of the first treatment period. One discontinued before randomization. No AEs were reported among the 4 participants who discontinued. AEs during treatment periods were assessed systematically with monthly surveys and phone calls. During the washout period, AEs were recorded when participants reported them.
|
0.00%
0/22 • Throughout the duration of the study; the study duration was approximately 9.5 months per participant
AE analyses included all participants who were randomized and received IP. Twenty-six participants provided informed consent, 25 were randomized, and 3 discontinued during the first month of the first treatment period. One discontinued before randomization. No AEs were reported among the 4 participants who discontinued. AEs during treatment periods were assessed systematically with monthly surveys and phone calls. During the washout period, AEs were recorded when participants reported them.
|
29.2%
7/24 • Throughout the duration of the study; the study duration was approximately 9.5 months per participant
AE analyses included all participants who were randomized and received IP. Twenty-six participants provided informed consent, 25 were randomized, and 3 discontinued during the first month of the first treatment period. One discontinued before randomization. No AEs were reported among the 4 participants who discontinued. AEs during treatment periods were assessed systematically with monthly surveys and phone calls. During the washout period, AEs were recorded when participants reported them.
|
|
Nervous system disorders
Nausea
|
4.3%
1/23 • Throughout the duration of the study; the study duration was approximately 9.5 months per participant
AE analyses included all participants who were randomized and received IP. Twenty-six participants provided informed consent, 25 were randomized, and 3 discontinued during the first month of the first treatment period. One discontinued before randomization. No AEs were reported among the 4 participants who discontinued. AEs during treatment periods were assessed systematically with monthly surveys and phone calls. During the washout period, AEs were recorded when participants reported them.
|
4.5%
1/22 • Throughout the duration of the study; the study duration was approximately 9.5 months per participant
AE analyses included all participants who were randomized and received IP. Twenty-six participants provided informed consent, 25 were randomized, and 3 discontinued during the first month of the first treatment period. One discontinued before randomization. No AEs were reported among the 4 participants who discontinued. AEs during treatment periods were assessed systematically with monthly surveys and phone calls. During the washout period, AEs were recorded when participants reported them.
|
8.3%
2/24 • Throughout the duration of the study; the study duration was approximately 9.5 months per participant
AE analyses included all participants who were randomized and received IP. Twenty-six participants provided informed consent, 25 were randomized, and 3 discontinued during the first month of the first treatment period. One discontinued before randomization. No AEs were reported among the 4 participants who discontinued. AEs during treatment periods were assessed systematically with monthly surveys and phone calls. During the washout period, AEs were recorded when participants reported them.
|
|
Gastrointestinal disorders
Heartburn
|
4.3%
1/23 • Throughout the duration of the study; the study duration was approximately 9.5 months per participant
AE analyses included all participants who were randomized and received IP. Twenty-six participants provided informed consent, 25 were randomized, and 3 discontinued during the first month of the first treatment period. One discontinued before randomization. No AEs were reported among the 4 participants who discontinued. AEs during treatment periods were assessed systematically with monthly surveys and phone calls. During the washout period, AEs were recorded when participants reported them.
|
0.00%
0/22 • Throughout the duration of the study; the study duration was approximately 9.5 months per participant
AE analyses included all participants who were randomized and received IP. Twenty-six participants provided informed consent, 25 were randomized, and 3 discontinued during the first month of the first treatment period. One discontinued before randomization. No AEs were reported among the 4 participants who discontinued. AEs during treatment periods were assessed systematically with monthly surveys and phone calls. During the washout period, AEs were recorded when participants reported them.
|
8.3%
2/24 • Throughout the duration of the study; the study duration was approximately 9.5 months per participant
AE analyses included all participants who were randomized and received IP. Twenty-six participants provided informed consent, 25 were randomized, and 3 discontinued during the first month of the first treatment period. One discontinued before randomization. No AEs were reported among the 4 participants who discontinued. AEs during treatment periods were assessed systematically with monthly surveys and phone calls. During the washout period, AEs were recorded when participants reported them.
|
|
Nervous system disorders
Headache
|
13.0%
3/23 • Throughout the duration of the study; the study duration was approximately 9.5 months per participant
AE analyses included all participants who were randomized and received IP. Twenty-six participants provided informed consent, 25 were randomized, and 3 discontinued during the first month of the first treatment period. One discontinued before randomization. No AEs were reported among the 4 participants who discontinued. AEs during treatment periods were assessed systematically with monthly surveys and phone calls. During the washout period, AEs were recorded when participants reported them.
|
4.5%
1/22 • Throughout the duration of the study; the study duration was approximately 9.5 months per participant
AE analyses included all participants who were randomized and received IP. Twenty-six participants provided informed consent, 25 were randomized, and 3 discontinued during the first month of the first treatment period. One discontinued before randomization. No AEs were reported among the 4 participants who discontinued. AEs during treatment periods were assessed systematically with monthly surveys and phone calls. During the washout period, AEs were recorded when participants reported them.
|
8.3%
2/24 • Throughout the duration of the study; the study duration was approximately 9.5 months per participant
AE analyses included all participants who were randomized and received IP. Twenty-six participants provided informed consent, 25 were randomized, and 3 discontinued during the first month of the first treatment period. One discontinued before randomization. No AEs were reported among the 4 participants who discontinued. AEs during treatment periods were assessed systematically with monthly surveys and phone calls. During the washout period, AEs were recorded when participants reported them.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/23 • Throughout the duration of the study; the study duration was approximately 9.5 months per participant
AE analyses included all participants who were randomized and received IP. Twenty-six participants provided informed consent, 25 were randomized, and 3 discontinued during the first month of the first treatment period. One discontinued before randomization. No AEs were reported among the 4 participants who discontinued. AEs during treatment periods were assessed systematically with monthly surveys and phone calls. During the washout period, AEs were recorded when participants reported them.
|
0.00%
0/22 • Throughout the duration of the study; the study duration was approximately 9.5 months per participant
AE analyses included all participants who were randomized and received IP. Twenty-six participants provided informed consent, 25 were randomized, and 3 discontinued during the first month of the first treatment period. One discontinued before randomization. No AEs were reported among the 4 participants who discontinued. AEs during treatment periods were assessed systematically with monthly surveys and phone calls. During the washout period, AEs were recorded when participants reported them.
|
8.3%
2/24 • Throughout the duration of the study; the study duration was approximately 9.5 months per participant
AE analyses included all participants who were randomized and received IP. Twenty-six participants provided informed consent, 25 were randomized, and 3 discontinued during the first month of the first treatment period. One discontinued before randomization. No AEs were reported among the 4 participants who discontinued. AEs during treatment periods were assessed systematically with monthly surveys and phone calls. During the washout period, AEs were recorded when participants reported them.
|
|
Hepatobiliary disorders
Transaminitis
|
8.7%
2/23 • Throughout the duration of the study; the study duration was approximately 9.5 months per participant
AE analyses included all participants who were randomized and received IP. Twenty-six participants provided informed consent, 25 were randomized, and 3 discontinued during the first month of the first treatment period. One discontinued before randomization. No AEs were reported among the 4 participants who discontinued. AEs during treatment periods were assessed systematically with monthly surveys and phone calls. During the washout period, AEs were recorded when participants reported them.
|
4.5%
1/22 • Throughout the duration of the study; the study duration was approximately 9.5 months per participant
AE analyses included all participants who were randomized and received IP. Twenty-six participants provided informed consent, 25 were randomized, and 3 discontinued during the first month of the first treatment period. One discontinued before randomization. No AEs were reported among the 4 participants who discontinued. AEs during treatment periods were assessed systematically with monthly surveys and phone calls. During the washout period, AEs were recorded when participants reported them.
|
0.00%
0/24 • Throughout the duration of the study; the study duration was approximately 9.5 months per participant
AE analyses included all participants who were randomized and received IP. Twenty-six participants provided informed consent, 25 were randomized, and 3 discontinued during the first month of the first treatment period. One discontinued before randomization. No AEs were reported among the 4 participants who discontinued. AEs during treatment periods were assessed systematically with monthly surveys and phone calls. During the washout period, AEs were recorded when participants reported them.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place