Trial Outcomes & Findings for Safety and Efficacy of AGN201781 in Neuropathic Pain (NCT NCT00533351)
NCT ID: NCT00533351
Last Updated: 2016-02-24
Results Overview
Change from baseline in the daily-average-pain score at week 2. This was measured using a 11-point (0 to 10) scale where 0 represented no pain and 10 represented worst pain. Due to the low number of patients completing the treatment period of the study no analyses were performed
TERMINATED
PHASE2
9 participants
Baseline, Week 2
2016-02-24
Participant Flow
There were 2 Treatment Periods in this Cross-Over Study. Patients randomized to AGN201781 during Period 1 received Placebo during Period 2. Patients randomized to Placebo during Period 1 received AGN201781 during Period 2. Period 3 was an Observational Period only (No treatment provided).
Participant milestones
| Measure |
AGN201781 Followed by Placebo
|
Placebo Followed by AGN201781
|
|---|---|---|
|
Period 1
STARTED
|
7
|
2
|
|
Period 1
COMPLETED
|
5
|
1
|
|
Period 1
NOT COMPLETED
|
2
|
1
|
|
Period 2
STARTED
|
5
|
1
|
|
Period 2
COMPLETED
|
5
|
1
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
|
Period 3
STARTED
|
3
|
0
|
|
Period 3
COMPLETED
|
3
|
0
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of AGN201781 in Neuropathic Pain
Baseline characteristics by cohort
| Measure |
AGN201781 Followed by Placebo
n=7 Participants
|
Placebo Followed by AGN201781
n=2 Participants
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.6 years
STANDARD_DEVIATION 11.01 • n=5 Participants
|
49 years
STANDARD_DEVIATION 36.77 • n=7 Participants
|
54.8 years
STANDARD_DEVIATION 23.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 2Population: Due to low number of patients completing the treatment period of the study no analyses were performed
Change from baseline in the daily-average-pain score at week 2. This was measured using a 11-point (0 to 10) scale where 0 represented no pain and 10 represented worst pain. Due to the low number of patients completing the treatment period of the study no analyses were performed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 2Population: Due to low number of patients completing the treatment period of the study no analyses were performed.
Change from baseline in Subject Global Impression of Change score at week 2. The Subject Global Impression of Change is a self-evaluation by the subject of their overall change in relief of neuropathic pain since the beginning of the study rated on a 7-point scale (1=very much improved to 7=very much worse). Due to low number of patients completing the treatment period of the study no analyses were performed.
Outcome measures
Outcome data not reported
Adverse Events
AGN201781 Followed by Placebo
Placebo Followed by AGN201781
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AGN201781 Followed by Placebo
n=7 participants at risk
|
Placebo Followed by AGN201781
n=2 participants at risk
|
|---|---|---|
|
General disorders
Fatigue
|
14.3%
1/7
|
0.00%
0/2
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
1/7
|
0.00%
0/2
|
|
Investigations
Blood creatinine increased
|
14.3%
1/7
|
0.00%
0/2
|
|
Nervous system disorders
Headache
|
14.3%
1/7
|
0.00%
0/2
|
|
Vascular disorders
Hypertension
|
14.3%
1/7
|
0.00%
0/2
|
|
Endocrine disorders
Hypothyroidism
|
14.3%
1/7
|
0.00%
0/2
|
|
Nervous system disorders
Somnolence
|
0.00%
0/7
|
50.0%
1/2
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/7
|
50.0%
1/2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/7
|
50.0%
1/2
|
|
Skin and subcutaneous tissue disorders
Pityriasis rosea
|
0.00%
0/7
|
50.0%
1/2
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/7
|
50.0%
1/2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 40 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
- Publication restrictions are in place
Restriction type: OTHER