Trial Outcomes & Findings for PK/PD Comparison of Guanfacine ER and IR (NCT NCT01904526)
NCT ID: NCT01904526
Last Updated: 2020-03-06
Results Overview
Evaluate whether a 4mg/day or 6mg/day dose of extended-release guanfacine produces pharmacokinetic (PK) properties similar to 3mg/day immediate release guanfacine by measuring plasma trough levels of guanfacine for each dose
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
+24 hours on Lab Session days (Days 22, 49, 58)
Results posted on
2020-03-06
Participant Flow
Participant milestones
| Measure |
Guanfacine
Guanfacine: 3mg/day immediate release (IR) with 3-week lead-in period. Maintained at steady state to complete lab session. After completion of lab session, 1-week lead-in medication period to 4mg/day extended release (ER). Maintained at steady state to complete lab session. After completion of lab session, 1-week lead-in medication period to 6mg/day ER. Maintained at steady state to complete lab session. 5-day taper after lab.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PK/PD Comparison of Guanfacine ER and IR
Baseline characteristics by cohort
| Measure |
Guanfacine
n=5 Participants
Guanfacine: 3mg/day IR with 3-week lead-in period. Maintained at steady state to complete lab session. After completion of lab session, 1-week lead-in medication period to 4mg/day ER. Maintained at steady state to complete lab session. After completion of lab session, 1-week lead-in medication period to 6mg/day ER. Maintained at steady state to complete lab session. 5-day taper after lab.
|
|---|---|
|
Age, Continuous
|
45.8 Years
STANDARD_DEVIATION 2.49 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: +24 hours on Lab Session days (Days 22, 49, 58)Population: 3 mg/day IR (Day 22) followed by 4mg/day ER (Day 49) followed by 6mg/day ER (Day 58)
Evaluate whether a 4mg/day or 6mg/day dose of extended-release guanfacine produces pharmacokinetic (PK) properties similar to 3mg/day immediate release guanfacine by measuring plasma trough levels of guanfacine for each dose
Outcome measures
| Measure |
Guanfacine 3mg/Day Immediate Release
n=5 Participants
Guanfacine: 3mg/day immediate release
|
Guanfacine 4mg/Day Extended Release
n=5 Participants
Guanfacine: 4mg/day extended release
|
Guanfacine 6mg/Day Extended Release
n=5 Participants
Guanfacine: 6mg/day extended release
|
|---|---|---|---|
|
Plasma Trough Levels of Guanfacine
|
3.40 ng/ml
Standard Error 0.33
|
3.46 ng/ml
Standard Error 0.67
|
5.92 ng/ml
Standard Error 1.02
|
SECONDARY outcome
Timeframe: Last day of titration period 1 (Day 21) to the last day of titration period 3 (Day 57)Population: Last day of titration period: 3 mg/day IR (Day 21) followed by 4mg/day ER (Day 48) followed by 6mg/day ER (Day 57)
Evaluate the safety and tolerability of guanfacine by measuring physiologic reactivity (e.g., heart rate)
Outcome measures
| Measure |
Guanfacine 3mg/Day Immediate Release
n=5 Participants
Guanfacine: 3mg/day immediate release
|
Guanfacine 4mg/Day Extended Release
n=5 Participants
Guanfacine: 4mg/day extended release
|
Guanfacine 6mg/Day Extended Release
n=5 Participants
Guanfacine: 6mg/day extended release
|
|---|---|---|---|
|
Heart Rate
|
59.6 beats per minute
Standard Error 1.75
|
58.8 beats per minute
Standard Error 3.97
|
61.6 beats per minute
Standard Error 5.30
|
SECONDARY outcome
Timeframe: Last day of titration period 1 (Day 21) to the last day of titration period 3 (Day 57)Population: Last day of titration period: 3 mg/day IR (Day 21) followed by 4 mg/kg ER (Day 48) followed by 6 mg/day ER (Day 57)
Evaluate the safety and tolerability of guanfacine by measuring physiologic reactivity (e.g., systolic blood pressure)
Outcome measures
| Measure |
Guanfacine 3mg/Day Immediate Release
n=5 Participants
Guanfacine: 3mg/day immediate release
|
Guanfacine 4mg/Day Extended Release
n=5 Participants
Guanfacine: 4mg/day extended release
|
Guanfacine 6mg/Day Extended Release
n=5 Participants
Guanfacine: 6mg/day extended release
|
|---|---|---|---|
|
Systolic Blood Pressure
|
101.0 mmHg
Standard Error 3.73
|
107.4 mmHg
Standard Error 7.51
|
108.4 mmHg
Standard Error 7.16
|
Adverse Events
Guanfacine 3mg/Day Immediate Release
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Guanfacine 4mg/Day Extended Release
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Guanfacine 6mg/Day Extended Release
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Guanfacine 3mg/Day Immediate Release
n=5 participants at risk
Guanfacine: 3mg/day immediate release
|
Guanfacine 4mg/Day Extended Release
n=5 participants at risk
Guanfacine: 4mg/day extended release
|
Guanfacine 6mg/Day Extended Release
n=5 participants at risk
Guanfacine: 6mg/day extended release
|
|---|---|---|---|
|
General disorders
Dry mouth
|
40.0%
2/5
|
80.0%
4/5
|
80.0%
4/5
|
|
General disorders
Drowsiness
|
60.0%
3/5
|
60.0%
3/5
|
60.0%
3/5
|
|
General disorders
Dizziness
|
40.0%
2/5
|
40.0%
2/5
|
40.0%
2/5
|
|
Gastrointestinal disorders
Constipation
|
40.0%
2/5
|
40.0%
2/5
|
40.0%
2/5
|
|
General disorders
Fatigue
|
60.0%
3/5
|
60.0%
3/5
|
60.0%
3/5
|
|
General disorders
Headache
|
40.0%
2/5
|
20.0%
1/5
|
0.00%
0/5
|
|
General disorders
Insomnia
|
0.00%
0/5
|
20.0%
1/5
|
0.00%
0/5
|
|
Gastrointestinal disorders
Gas pains
|
40.0%
2/5
|
40.0%
2/5
|
60.0%
3/5
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
1/5
|
0.00%
0/5
|
0.00%
0/5
|
|
General disorders
Loss of appetite
|
20.0%
1/5
|
0.00%
0/5
|
20.0%
1/5
|
|
General disorders
Runny nose
|
20.0%
1/5
|
0.00%
0/5
|
20.0%
1/5
|
|
General disorders
Weakness
|
20.0%
1/5
|
0.00%
0/5
|
40.0%
2/5
|
|
General disorders
Nausea/vomiting
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
Cardiac disorders
Chest pain
|
20.0%
1/5
|
0.00%
0/5
|
0.00%
0/5
|
|
General disorders
Shortness of breath
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
General disorders
Skin rash
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
General disorders
Swelling of hands or feet
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
General disorders
Blurred vision
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
General disorders
Yellowing of the eyes or skin
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
General disorders
Mental/mood changes
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
General disorders
Tingling of the hands or feet
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
General disorders
Impotence
|
40.0%
2/5
|
0.00%
0/5
|
20.0%
1/5
|
|
General disorders
Decreased sexual desire
|
20.0%
1/5
|
0.00%
0/5
|
20.0%
1/5
|
|
General disorders
Vision changes
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/5
|
|
General disorders
Taste changes
|
20.0%
1/5
|
20.0%
1/5
|
20.0%
1/5
|
|
General disorders
Ringing in ears
|
20.0%
1/5
|
20.0%
1/5
|
20.0%
1/5
|
|
General disorders
Leg cramps
|
0.00%
0/5
|
0.00%
0/5
|
20.0%
1/5
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
1/5
|
0.00%
0/5
|
0.00%
0/5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place