N/A
Completed N=325
PASCONAL NERVENTROPFEN in the Treatment of Nervous Diseases
Nervousness · Sleep Disorders, Intrinsic
Source: ClinicalTrials.gov NCT01125605 ↗
Enrolled (actual)
325
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcomePrimary: Sumscore of 12 Individual Symptoms for Visit 1 (Baseline), Visit 2, and Visit 3 — 15.8; 9.2; 5.1; 6.2 units on a scale
Summary
The purpose of this observational study is to give an overview of the use of PASCONAL NERVENTROPFEN in a 2-4 week treatment of nervous diseases, especially sleep disorders due to nervousness.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sumscore of 12 Individual Symptoms for Visit 1 (Baseline), Visit 2, and Visit 3 |
15.8; 9.2; 5.1; 6.2 | — |
| PRIMARY Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation |
0; 23; 78; 79; 63; 171 | — |
| PRIMARY Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation |
0; 41; 111; 115; 86; 163 | — |
| PRIMARY Tolerability After Visit 2 and Visit 3 |
313; 303; 13; 23 | — |
| SECONDARY Changes of the Sum Score Between Baseline and Last Observation by Concomitant Medication and Treatment Duration |
15.9; 7.7; 15.7; 5.8; 14.3; 7.4 | 0.0033 sig |
| SECONDARY Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Concomitant Medication |
46; 206; 19; 32; 3; 2 | 0.0014 sig |
| SECONDARY Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Duration of Treatment |
46; 206; 16; 35; 3; 2 | 0.0125 sig |
| SECONDARY Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Concomitant Medication |
43; 195; 21; 30; 2; 2 | 0.0006 sig |
| SECONDARY Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Duration of Treatment |
40; 198; 19; 32; 2; 2 | 0.0016 sig |
| SECONDARY Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Concomitant Medication (Yes/no) |
40; 128; 18; 34; 10; 12 | 0.0504 |
| SECONDARY Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Treatment Duration |
25; 143; 16; 36; 11; 11 | 0.0002 sig |
Eligibility Criteria
Due to the design as an Observational Study no inclusion or exclusion criteria for therapy are named. The included patient group is described under "Cohort / Group".
Observational Criteria (=inclusion criteria for documentation):
- Males and females
- Children 1-12 years old
- Adults >12 years old
- suffering from nervous diseases, e.g. sleep disorders due to nervousness.
Exclusion criteria for documentation:
- children younger than 1 year
- no nervous diseases, e.g. sleep disorders due to nervousness.
- no treatment with PASCONAL NERVENTROPFEN
Data sourced from ClinicalTrials.gov (NCT01125605). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.