Trial Outcomes & Findings for PASCONAL NERVENTROPFEN in the Treatment of Nervous Diseases (NCT NCT01125605)
NCT ID: NCT01125605
Last Updated: 2015-04-14
Results Overview
The severity of 12 symptoms (nervousness/restlessness, irritability/eccentricity, sleep disorders, fitful sleep, hyperactivity, nocturnal activity, lack of concentration/forgetfulness, tiredness, discontent, listlessness, gastrointestinal problems, and headache/pressure) was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints) and for the sum score of all 12 individual symptom scores (0 (no complaints) - 36 (all strong complaints).
COMPLETED
325 participants
begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)
2015-04-14
Participant Flow
Physicians who were registered in the past with the treatment focus on central nervous system / psyche. The recruitment of the participating physicians was done by the field service of PASCOE.
It was an non-inteventional observational study with 3 visits.
Participant milestones
| Measure |
Observational Group
Pasconal Nerventropfen PASCONAL® NERVENTROPFEN is a homoeopathic combination product (oral drops) consisting out of 4 ingredients: Avena sativa, Valeriana, Ignatia and Tarantula.
|
|---|---|
|
Overall Study
STARTED
|
325
|
|
Overall Study
Safety
|
326
|
|
Overall Study
COMPLETED
|
325
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PASCONAL NERVENTROPFEN in the Treatment of Nervous Diseases
Baseline characteristics by cohort
| Measure |
Observational Group
n=325 Participants
Pasconal Nerventropfen
|
|---|---|
|
Age, Categorical
<=18 years
|
72 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
212 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
229 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
96 Participants
n=5 Participants
|
|
Concomitant medication
with concomitant medication
|
176 participants
n=5 Participants
|
|
Concomitant medication
without concomitant medication
|
149 participants
n=5 Participants
|
|
Duration of disease years
|
2.0 years
STANDARD_DEVIATION 3.8 • n=5 Participants
|
|
State of inclusion diagnosis
acute (<= 2 months)
|
43 participants
n=5 Participants
|
|
State of inclusion diagnosis
subchronic/chronic (> 2 months)
|
163 participants
n=5 Participants
|
|
State of inclusion diagnosis
missing data
|
119 participants
n=5 Participants
|
|
Previous treatment of inclusion diagnosis
with previous treatment of inclusion diagnosis
|
245 participants
n=5 Participants
|
|
Previous treatment of inclusion diagnosis
without previous treatment of inclusion diagnosis
|
80 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)Population: descriptive; for all partcipations with values at the visits
The severity of 12 symptoms (nervousness/restlessness, irritability/eccentricity, sleep disorders, fitful sleep, hyperactivity, nocturnal activity, lack of concentration/forgetfulness, tiredness, discontent, listlessness, gastrointestinal problems, and headache/pressure) was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints) and for the sum score of all 12 individual symptom scores (0 (no complaints) - 36 (all strong complaints).
Outcome measures
| Measure |
Visit 1
n=325 Participants
Observational group (Pasconal Nerventropfen) at visit 1
|
Visit 2
n=325 Participants
Observational group (Pasconal Nerventropfen) at visit 2
|
Visit 3
n=309 Participants
Observational group (Pasconal Nerventropfen) at visit 3
|
Last Observation
n=325 Participants
Observational group (Pasconal Nerventropfen) at last observation
|
|---|---|---|---|---|
|
Sumscore of 12 Individual Symptoms for Visit 1 (Baseline), Visit 2, and Visit 3
|
15.8 units on a scale
Standard Deviation 6.1
|
9.2 units on a scale
Standard Deviation 5.6
|
5.1 units on a scale
Standard Deviation 4.5
|
6.2 units on a scale
Standard Deviation 5.2
|
PRIMARY outcome
Timeframe: begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)Population: descriptive; for all partcipations with values at the visits
The severity of nervousness/restlessness was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints).
Outcome measures
| Measure |
Visit 1
n=308 Participants
Observational group (Pasconal Nerventropfen) at visit 1
|
Visit 2
n=306 Participants
Observational group (Pasconal Nerventropfen) at visit 2
|
Visit 3
n=293 Participants
Observational group (Pasconal Nerventropfen) at visit 3
|
Last Observation
n=308 Participants
Observational group (Pasconal Nerventropfen) at last observation
|
|---|---|---|---|---|
|
Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation
0=not present
|
0 participants
|
23 participants
|
78 participants
|
79 participants
|
|
Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation
1=mild
|
63 participants
|
171 participants
|
180 participants
|
789 participants
|
|
Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation
2=moderate
|
166 participants
|
98 participants
|
26 participants
|
29 participants
|
|
Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation
3=Strong
|
79 participants
|
14 participants
|
9 participants
|
11 participants
|
PRIMARY outcome
Timeframe: begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)Population: descriptive; for all partcipations with values at the visits
The severity of irritability/eccentricity was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints).
Outcome measures
| Measure |
Visit 1
n=293 Participants
Observational group (Pasconal Nerventropfen) at visit 1
|
Visit 2
n=291 Participants
Observational group (Pasconal Nerventropfen) at visit 2
|
Visit 3
n=278 Participants
Observational group (Pasconal Nerventropfen) at visit 3
|
Last Observation
n=293 Participants
Observational group (Pasconal Nerventropfen) at last observation
|
|---|---|---|---|---|
|
Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation
3=Strong
|
67 participants
|
15 participants
|
6 participants
|
9 participants
|
|
Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation
0=not present
|
0 participants
|
41 participants
|
111 participants
|
115 participants
|
|
Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation
1=mild
|
86 participants
|
163 participants
|
136 participants
|
142 participants
|
|
Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation
2=moderate
|
140 participants
|
72 participants
|
25 participants
|
27 participants
|
PRIMARY outcome
Timeframe: appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)Population: descriptive; for safety 326 patients were analysed; 1 patient had no efficacy values and were not analysed for efficacy; so a discrepancy between 325 patients (for efficacy) and 326 (for safety) occured
Assessment of tolerability at visit 2 and visit 3 well tolerated = no side effcts poor tolerated = side effects
Outcome measures
| Measure |
Visit 1
n=326 Participants
Observational group (Pasconal Nerventropfen) at visit 1
|
Visit 2
n=326 Participants
Observational group (Pasconal Nerventropfen) at visit 2
|
Visit 3
Observational group (Pasconal Nerventropfen) at visit 3
|
Last Observation
Observational group (Pasconal Nerventropfen) at last observation
|
|---|---|---|---|---|
|
Tolerability After Visit 2 and Visit 3
well tolerated
|
313 participants
|
303 participants
|
—
|
—
|
|
Tolerability After Visit 2 and Visit 3
poor tolerated
|
13 participants
|
23 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: begin (visit 1) and last obvservation (could be appr. after 2 weeks (visit 2) or 4 weeks (visit 3))Population: exploratively, all participations with values
The severity of 12 symptoms (nervousness/restlessness, irritability/eccentricity, sleep disorders, fitful sleep, hyperactivity, nocturnal activity, lack of concentration/forgetfulness, tiredness, discontent, listlessness, gastrointestinal problems, and headache/pressure) was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints) and for the sum score of all 12 individual symptom scores (0 (no complaints) - 36 (all strong complaints). Decrease of the sumscore between baseline and last observation by concomitant medication (with and withour medication) and treatment duration (\< 4 weeks and \>= 4 weeks)
Outcome measures
| Measure |
Visit 1
n=325 Participants
Observational group (Pasconal Nerventropfen) at visit 1
|
Visit 2
n=325 Participants
Observational group (Pasconal Nerventropfen) at visit 2
|
Visit 3
Observational group (Pasconal Nerventropfen) at visit 3
|
Last Observation
Observational group (Pasconal Nerventropfen) at last observation
|
|---|---|---|---|---|
|
Changes of the Sum Score Between Baseline and Last Observation by Concomitant Medication and Treatment Duration
with concomitant medication
|
15.9 units on a scale
Standard Deviation 5.5
|
7.7 units on a scale
Standard Deviation 5.6
|
—
|
—
|
|
Changes of the Sum Score Between Baseline and Last Observation by Concomitant Medication and Treatment Duration
without concomitant medication
|
15.7 units on a scale
Standard Deviation 6.2
|
5.8 units on a scale
Standard Deviation 5.0
|
—
|
—
|
|
Changes of the Sum Score Between Baseline and Last Observation by Concomitant Medication and Treatment Duration
< 4 weeks treatment duration
|
14.3 units on a scale
Standard Deviation 5.3
|
7.4 units on a scale
Standard Deviation 6.0
|
—
|
—
|
|
Changes of the Sum Score Between Baseline and Last Observation by Concomitant Medication and Treatment Duration
>= 4 weeks treatment duration
|
16.1 units on a scale
Standard Deviation 6.2
|
5.9 units on a scale
Standard Deviation 4.9
|
—
|
—
|
SECONDARY outcome
Timeframe: begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))Population: exploratively, all participations with values
The symptom nervousness/restlessnesswas analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories "improved", "unchanged" and "worsened". For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was \> 0).
Outcome measures
| Measure |
Visit 1
n=68 Participants
Observational group (Pasconal Nerventropfen) at visit 1
|
Visit 2
n=240 Participants
Observational group (Pasconal Nerventropfen) at visit 2
|
Visit 3
Observational group (Pasconal Nerventropfen) at visit 3
|
Last Observation
Observational group (Pasconal Nerventropfen) at last observation
|
|---|---|---|---|---|
|
Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Concomitant Medication
improved
|
46 participants
|
206 participants
|
—
|
—
|
|
Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Concomitant Medication
unchanged
|
19 participants
|
32 participants
|
—
|
—
|
|
Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Concomitant Medication
worsened
|
3 participants
|
2 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))Population: exploratively, all participations with values
The symptom nervousness/restlessness was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories "improved", "unchanged" and "worsened". For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was \> 0).
Outcome measures
| Measure |
Visit 1
n=65 Participants
Observational group (Pasconal Nerventropfen) at visit 1
|
Visit 2
n=243 Participants
Observational group (Pasconal Nerventropfen) at visit 2
|
Visit 3
Observational group (Pasconal Nerventropfen) at visit 3
|
Last Observation
Observational group (Pasconal Nerventropfen) at last observation
|
|---|---|---|---|---|
|
Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Duration of Treatment
improved
|
46 participants
|
206 participants
|
—
|
—
|
|
Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Duration of Treatment
unchanged
|
16 participants
|
35 participants
|
—
|
—
|
|
Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Duration of Treatment
worsened
|
3 participants
|
2 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))Population: exploratively, all participations with values
The symptom irritability/eccentricity was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories "improved", "unchanged" and "worsened". For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was \> 0).
Outcome measures
| Measure |
Visit 1
n=66 Participants
Observational group (Pasconal Nerventropfen) at visit 1
|
Visit 2
n=227 Participants
Observational group (Pasconal Nerventropfen) at visit 2
|
Visit 3
Observational group (Pasconal Nerventropfen) at visit 3
|
Last Observation
Observational group (Pasconal Nerventropfen) at last observation
|
|---|---|---|---|---|
|
Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Concomitant Medication
worsened
|
2 participants
|
2 participants
|
—
|
—
|
|
Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Concomitant Medication
improved
|
43 participants
|
195 participants
|
—
|
—
|
|
Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Concomitant Medication
unchanged
|
21 participants
|
30 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: begin (visit 1) and last observation (appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))Population: exploratively, all participations with values
The symptom irritability/eccentricity was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories "improved", "unchanged" and "worsened". For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was \> 0).
Outcome measures
| Measure |
Visit 1
n=61 Participants
Observational group (Pasconal Nerventropfen) at visit 1
|
Visit 2
n=232 Participants
Observational group (Pasconal Nerventropfen) at visit 2
|
Visit 3
Observational group (Pasconal Nerventropfen) at visit 3
|
Last Observation
Observational group (Pasconal Nerventropfen) at last observation
|
|---|---|---|---|---|
|
Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Duration of Treatment
worsened
|
2 participants
|
2 participants
|
—
|
—
|
|
Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Duration of Treatment
improved
|
40 participants
|
198 participants
|
—
|
—
|
|
Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Duration of Treatment
unchanged
|
19 participants
|
32 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3)Population: exploratively, all participations with values
Efficacy of the therapy with PASCONAL® NERVENTROPFEN was rated by the physician on a 4-point rating scale at Visit 2 and Visit 3. The same scale was applied at Visit 1 for evaluation of the efficacy of the previous medication. The last evaluation for PASCONAL® NERVENTROPFEN (Visit 2 or Visit 3, according to the LOCF principle) was compared with the rating for the previous therapy by means of the categories "PASCONAL® better", "No difference" and "PASCONAL® worse".
Outcome measures
| Measure |
Visit 1
n=68 Participants
Observational group (Pasconal Nerventropfen) at visit 1
|
Visit 2
n=174 Participants
Observational group (Pasconal Nerventropfen) at visit 2
|
Visit 3
Observational group (Pasconal Nerventropfen) at visit 3
|
Last Observation
Observational group (Pasconal Nerventropfen) at last observation
|
|---|---|---|---|---|
|
Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Concomitant Medication (Yes/no)
PASCONAL better
|
40 participants
|
128 participants
|
—
|
—
|
|
Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Concomitant Medication (Yes/no)
No difference
|
18 participants
|
34 participants
|
—
|
—
|
|
Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Concomitant Medication (Yes/no)
PACONAL worse
|
10 participants
|
12 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3)Population: exploratively, all participations with values
Efficacy of the therapy with PASCONAL® NERVENTROPFEN was rated by the physician on a 4-point rating scale at Visit 2 and Visit 3. The same scale was applied at Visit 1 for evaluation of the efficacy of the previous medication. The last evaluation for PASCONAL® NERVENTROPFEN (Visit 2 or Visit 3, according to the LOCF principle) was compared with the rating for the previous therapy by means of the categories "PASCONAL® better", "No difference" and "PASCONAL® worse".
Outcome measures
| Measure |
Visit 1
n=52 Participants
Observational group (Pasconal Nerventropfen) at visit 1
|
Visit 2
n=190 Participants
Observational group (Pasconal Nerventropfen) at visit 2
|
Visit 3
Observational group (Pasconal Nerventropfen) at visit 3
|
Last Observation
Observational group (Pasconal Nerventropfen) at last observation
|
|---|---|---|---|---|
|
Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Treatment Duration
No difference
|
16 participants
|
36 participants
|
—
|
—
|
|
Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Treatment Duration
PASCONAL better
|
25 participants
|
143 participants
|
—
|
—
|
|
Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Treatment Duration
PACONAL worse
|
11 participants
|
11 participants
|
—
|
—
|
Adverse Events
Observational Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Observational Group
n=326 participants at risk
Pasconal Nerventropfen
|
|---|---|
|
Gastrointestinal disorders
gastrointestinal
|
0.61%
2/326 • Number of events 2 • after appr. 2 weeks and after appr. 4 weeks
|
|
Gastrointestinal disorders
nausea
|
0.61%
2/326 • Number of events 2 • after appr. 2 weeks and after appr. 4 weeks
|
|
General disorders
tiredness
|
0.92%
3/326 • Number of events 3 • after appr. 2 weeks and after appr. 4 weeks
|
|
Nervous system disorders
headache
|
0.61%
2/326 • Number of events 2 • after appr. 2 weeks and after appr. 4 weeks
|
|
Cardiac disorders
tachycardia
|
0.31%
1/326 • Number of events 1 • after appr. 2 weeks and after appr. 4 weeks
|
|
Gastrointestinal disorders
heartburn
|
0.31%
1/326 • Number of events 1 • after appr. 2 weeks and after appr. 4 weeks
|
|
Psychiatric disorders
aggressivity
|
0.31%
1/326 • Number of events 1 • after appr. 2 weeks and after appr. 4 weeks
|
|
Gastrointestinal disorders
stomach ache
|
0.31%
1/326 • Number of events 1 • after appr. 2 weeks and after appr. 4 weeks
|
|
Gastrointestinal disorders
tongue and mucosa under tongue
|
0.31%
1/326 • Number of events 1 • after appr. 2 weeks and after appr. 4 weeks
|
Additional Information
Director of Clinical Trials
Pascoe pharmazeutische Praeparate GmbH
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place