N/A
N=325
PASCONAL NERVENTROPFEN in the Treatment of Nervous Diseases
Nervousness · Sleep Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01125605 ↗Enrolled (actual)
325
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult · 1+ yrs
- Sex
- All
- Sponsor
- Pascoe Pharmazeutische Praeparate GmbH
- Primary completion
- Oct 2010
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 |
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.
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.