HealthyPhase 1NCAG 5209NCT01047605
Pharmacological Effects of Neurapas® Balance and Pascoflair® 425 mg on Brain Activity in Healthy Volunteers
A Phase 1 study testing Neurapas balance, Pascoflair 425 mg and P-Tabletten weiß in people with Healthy, run by Pascoe Pharmazeutische Praeparate GmbH at 1 site in Germany.
Trial summary
To evaluate the pharmacological effects of two herbal medicinal products (Neurapas balance and Pascoflair 425 mg) in comparison to placebo on brain activity. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Neurapas balance, Pascoflair 425 mg and P-Tabletten weiß
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Mar 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female volunteers
- 30 - 70 years (extremes included)
- Medical history without any study relevant pathological findings
- Written and signed informed consent
Who cannot join
- Clinically study relevant acute or chronic disorders, that can be detected by clinical investigation or medical history
- Clinical, study-relevant pathological findings of clinical oar laboratory investigations
- Clinically relevant pathological EEG findings (e.g. artefact-free parts in Screening-EEG <30% in one recording
- Clinically relevant allergies
- positive alcohol testing on Screening, Day A, B, or C, or anamnestic
- positive drug screening test on Screening, Day A, B, or C, or anamnestic
Show all 18Show fewer
- Intake of study relevant medication 14 days prior to active Day A, or during active study duration, based on the volunteer´s information
- Regular intake of drug with primary central nervous effects (e.g. psychoactive drugs or central acting antihypertensive drugs)
- Known hypersensitivity / allergy against herbal extracts (i.e. dry extracts of Passionflower herb, St. John´s Wort herb, Valerian root) or lactose or an other excipient of the investigational medication
- Lapp-lactase deficiency (anamnestic)
- Hypersensitivity of the skin (anamnestic)
- BMI (Body-Mass-Index) <18 or>30
- Abuse of caffeine, teeine, or tobacco
- Smoking in the investigational site on Day A, B, or C
- Participation in an other clinical study within 60 days prior to Screening
- Positive Pregnancy Test (on Screening, Day A, B, or C) or Lactation
- Bad compliance
- Revocation of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Pharmacological Effects of NEURAPAS® Balance and PASCOFLAIR® 425 mg by Quantitative Measurement of Brain Activity in 16 Healthy Volunteers. A Single-blinded, Randomised, Placebo-controlled, 3-armed Phase-I-study With Cross-over Design
To evaluate the pharmacological effects of two herbal medicinal products (Neurapas balance and Pascoflair 425 mg) in comparison to placebo on brain activity.
Read the detailed description
Evaluation of the pharmacological effects of Neurapas® balance and Pascoflair® 425 mg by quantitative measurement of brain activity in 16 healthy volunteers.
- Conditions
- Healthy
- Being tested
- Neurapas balance, Pascoflair 425 mg, P-Tabletten weiß
- Keywords
- qEEG, herbal medicine, cognitive function, Neurapas balance, Pascoflair, hypericum, passionflower, valerian, Healthy volunteers, Influence on quantitative electro-encephalogram (qEEG).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurapas balanceDrug
6 tablets single dose
Pascoflair 425 mgDrug
3 tablets , single dose
P-Tabletten weißDrug
3 tablets, single dose
| Study group | Role | What they receive |
|---|---|---|
| PP1 | Experimental | Neurapas balance Receives: Drug: Neurapas balance |
| PP2 | Experimental | Pascoflair 425 mg Receives: Drug: Pascoflair 425 mg |
| PL1 | Placebo comparator | P-Tabletten weiß Receives: Drug: P-Tabletten weiß |
What is being measured
The primary outcome is the main question the study is designed to answer.
Z1: qEEG (total): Median change of electrical activity (qEEG: of all electrode positions) compared to Baseline (PP1 vs PP2 vs Placebo)
Measured: 5 times within 4 h
Secondary outcomes (6)
Comparison PP1 vs PP2 vs Placebo: Z2: qEEG (all frequencies, Clusters): Median change of electrical activity (qEEG: of selective brain-regional clusters of electrode positions) compared to Baseline
Measured: 5 times within 4 h
Comparison PP1 vs PP2 vs Placebo: Z3:qEEG (d2, beta1 (Cluster F7/T3))
Measured: 5 times wihtin 4 h
Comparison PP1 vs PP2 vs Placebo: Z4:qEEG (ME, theta (Cluster F7/T3/T6))
Measured: 5 times within 4 h
Comparison PP1 vs PP2 vs Placebo: Z5:qEEG (KLT, theta (Cluster F7/T3) + alpha (Cluster T4/T6))
Measured: 5 times within 4 h
Comparison PP1 vs PP2 vs Placebo: Z6: qEEG (Aa, all frequencies, Cluster C3/T3/P4)
Measured: 5 times within 4 h
Comparison PP1 vs PP2 vs Placebo: Z7: Timely onset of effect and duration of effect
Measured: 5 times within 4 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pascoe Pharmazeutische Praeparate GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Winfried Wedekind, MD, PhD, Principal investigator, Neurocoed AG, Sportparkstr. 9, D-35578 Wetzlar, GermanyWilfried Dimpfel, Prof, Study chair, Neurocode AG, Sportparkstr. 9, D-35578 Wetzlar, GermanyAnja Braschoss, MD, Study director, Pascoe Pharmazeutische Praeparate GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047605
- Sponsor's protocol ID
- 173 S 09 PSY
- Other IDs
- 2009-015827-97, 2009
- Acronym
- NCAG 5209
- Status last verified
- May 2010
- First submitted
- 12 Jan 2010
- Last updated
- 17 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Dimpfel W, Koch K, Weiss G. Early effect of NEURAPAS(R) balance on current source density (CSD) of human EEG. BMC Psychiatry. 2011 Aug 2;11:123. doi: 10.1186/1471-244X-11-123.
PubMed 21810233
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Pharmacological Effects of NEURAPAS® Balance and PASCOFLAIR® 425 mg by Quantitative Measurement of Brain Activity in 16 Healthy Volunteers. A Single-blinded, Randomised, Placebo-controlled, 3-armed Phase-I-study With Cross-over Design
- ClinicalTrials.gov ID
- NCT01047605
- Acronym / sponsor ID
- NCAG 5209 / 173 S 09 PSY
- Conditions
- Healthy
- Keywords
- qEEG, herbal medicine, cognitive function, Neurapas balance, Pascoflair, hypericum, passionflower, valerian
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Pascoe Pharmazeutische Praeparate GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 13 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the pharmacological effects of two herbal medicinal products (Neurapas balance and Pascoflair 425 mg) in comparison to placebo on brain activity.
Detailed description
Evaluation of the pharmacological effects of Neurapas® balance and Pascoflair® 425 mg by quantitative measurement of brain activity in 16 healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PP1 | Experimental | Drug: Neurapas balanceNeurapas balance |
| PP2 | Experimental | Drug: Pascoflair 425 mgPascoflair 425 mg |
| PL1 | Placebo comparator | Drug: P-Tabletten weißP-Tabletten weiß |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male and female volunteers
- 30 - 70 years (extremes included)
- Medical history without any study relevant pathological findings
- Written and signed informed consent
Key exclusion criteria (18 listed)
- Clinically study relevant acute or chronic disorders, that can be detected by clinical investigation or medical history
- Clinical, study-relevant pathological findings of clinical oar laboratory investigations
- Clinically relevant pathological EEG findings (e.g. artefact-free parts in Screening-EEG <30% in one recording
- Clinically relevant allergies
- positive alcohol testing on Screening, Day A, B, or C, or anamnestic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurapas balance6 tablets single dose | Drug | PP1 |
| Pascoflair 425 mg3 tablets , single dose | Drug | PP2 |
| P-Tabletten weiß3 tablets, single dose | Drug | PL1 |
Primary outcome
Z1: qEEG (total): Median change of electrical activity (qEEG: of all electrode positions) compared to Baseline (PP1 vs PP2 vs Placebo)
Time frame: 5 times within 4 h
6 secondary outcomes
Comparison PP1 vs PP2 vs Placebo: Z2: qEEG (all frequencies, Clusters): Median change of electrical activity (qEEG: of selective brain-regional clusters of electrode positions) compared to Baseline
Time frame: 5 times within 4 h
Comparison PP1 vs PP2 vs Placebo: Z3:qEEG (d2, beta1 (Cluster F7/T3))
Time frame: 5 times wihtin 4 h
Comparison PP1 vs PP2 vs Placebo: Z4:qEEG (ME, theta (Cluster F7/T3/T6))
Time frame: 5 times within 4 h
Comparison PP1 vs PP2 vs Placebo: Z5:qEEG (KLT, theta (Cluster F7/T3) + alpha (Cluster T4/T6))
Time frame: 5 times within 4 h
Comparison PP1 vs PP2 vs Placebo: Z6: qEEG (Aa, all frequencies, Cluster C3/T3/P4)
Time frame: 5 times within 4 h
Comparison PP1 vs PP2 vs Placebo: Z7: Timely onset of effect and duration of effect
Time frame: 5 times within 4 h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2010.
- Derived from this study: PubMed 21810233Dimpfel W, Koch K, Weiss G. Early effect of NEURAPAS(R) balance on current source density (CSD) of human EEG. BMC Psychiatry. 2011 Aug 2;11:123. doi: 10.1186/1471-244X-11-123.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winfried Wedekind, MD, PhD principal investigator
Neurocoed AG, Sportparkstr. 9, D-35578 Wetzlar, Germany
Wilfried Dimpfel, Prof study chair
Neurocode AG, Sportparkstr. 9, D-35578 Wetzlar, Germany
Anja Braschoss, MD study director
Pascoe Pharmazeutische Praeparate GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Neurapas balance, Pascoflair 425 mg and P-Tabletten weiß in people with Healthy, run by Pascoe Pharmazeutische Praeparate GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Z1: qEEG (total): Median change of electrical activity (qEEG: of all electrode positions) compared to Baseline (PP1 vs PP2 vs Placebo) (time frame: 5 times within 4 h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01047605, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2010.