Ignite Creation Date:
2025-12-25 @ 3:15 AM
Ignite Modification Date:
2025-12-29 @ 4:04 AM
Study NCT ID:
NCT01047605
Status:
COMPLETED
Last Update Posted:
2010-05-17
First Post:
2010-01-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacological Effects of Neurapas® Balance and Pascoflair® 425 mg on Brain Activity in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-14', 'studyFirstSubmitDate': '2010-01-12', 'studyFirstSubmitQcDate': '2010-01-12', 'lastUpdatePostDateStruct': {'date': '2010-05-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Z1: qEEG (total): Median change of electrical activity (qEEG: of all electrode positions) compared to Baseline (PP1 vs PP2 vs Placebo)', 'timeFrame': '5 times within 4 h'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': '5 times within 4 h'}, {'measure': 'Comparison PP1 vs PP2 vs Placebo: Z3:qEEG (d2, beta1 (Cluster F7/T3))', 'timeFrame': '5 times wihtin 4 h'}, {'measure': 'Comparison PP1 vs PP2 vs Placebo: Z4:qEEG (ME, theta (Cluster F7/T3/T6))', 'timeFrame': '5 times within 4 h'}, {'measure': 'Comparison PP1 vs PP2 vs Placebo: Z5:qEEG (KLT, theta (Cluster F7/T3) + alpha (Cluster T4/T6))', 'timeFrame': '5 times within 4 h'}, {'measure': 'Comparison PP1 vs PP2 vs Placebo: Z6: qEEG (Aa, all frequencies, Cluster C3/T3/P4)', 'timeFrame': '5 times within 4 h'}, {'measure': 'Comparison PP1 vs PP2 vs Placebo: Z7: Timely onset of effect and duration of effect', 'timeFrame': '5 times within 4 h'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['qEEG', 'herbal medicine', 'cognitive function', 'Neurapas balance', 'Pascoflair', 'hypericum', 'passionflower', 'valerian', 'Healthy volunteers', 'Influence on quantitative electro-encephalogram (qEEG).'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '21810233', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the pharmacological effects of two herbal medicinal products (Neurapas balance and Pascoflair 425 mg) in comparison to placebo on brain activity.', 'detailedDescription': 'Evaluation of the pharmacological effects of Neurapas® balance and Pascoflair® 425 mg by quantitative measurement of brain activity in 16 healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and female volunteers\n* 30 - 70 years (extremes included)\n* Medical history without any study relevant pathological findings\n* Written and signed informed consent\n\nExclusion Criteria:\n\n* Clinically study relevant acute or chronic disorders, that can be detected by clinical investigation or medical history\n* Clinical, study-relevant pathological findings of clinical oar laboratory investigations\n* Clinically relevant pathological EEG findings (e.g. artefact-free parts in Screening-EEG \\<30% in one recording\n* Clinically relevant allergies\n* positive alcohol testing on Screening, Day A, B, or C, or anamnestic\n* positive drug screening test on Screening, Day A, B, or C, or anamnestic\n* Intake of study relevant medication 14 days prior to active Day A, or during active study duration, based on the volunteer´s information\n* Regular intake of drug with primary central nervous effects (e.g. psychoactive drugs or central acting antihypertensive drugs)\n* 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\n* Lapp-lactase deficiency (anamnestic)\n* Hypersensitivity of the skin (anamnestic)\n* BMI (Body-Mass-Index) \\<18 or\\>30\n* Abuse of caffeine, teeine, or tobacco\n* Smoking in the investigational site on Day A, B, or C\n* Participation in an other clinical study within 60 days prior to Screening\n* Positive Pregnancy Test (on Screening, Day A, B, or C) or Lactation\n* Bad compliance\n* Revocation of informed consent'}, 'identificationModule': {'nctId': 'NCT01047605', 'acronym': 'NCAG 5209', 'briefTitle': 'Pharmacological Effects of Neurapas® Balance and Pascoflair® 425 mg on Brain Activity in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pascoe Pharmazeutische Praeparate GmbH'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '173 S 09 PSY'}, 'secondaryIdInfos': [{'id': '2009-015827-97', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PP1', 'description': 'Neurapas balance', 'interventionNames': ['Drug: Neurapas balance']}, {'type': 'EXPERIMENTAL', 'label': 'PP2', 'description': 'Pascoflair 425 mg', 'interventionNames': ['Drug: Pascoflair 425 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PL1', 'description': 'P-Tabletten weiß', 'interventionNames': ['Drug: P-Tabletten weiß']}], 'interventions': [{'name': 'Neurapas balance', 'type': 'DRUG', 'description': '6 tablets single dose', 'armGroupLabels': ['PP1']}, {'name': 'Pascoflair 425 mg', 'type': 'DRUG', 'description': '3 tablets , single dose', 'armGroupLabels': ['PP2']}, {'name': 'P-Tabletten weiß', 'type': 'DRUG', 'description': '3 tablets, single dose', 'armGroupLabels': ['PL1']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-35578', 'city': 'Wetzlar', 'country': 'Germany', 'facility': 'Neurocode AG', 'geoPoint': {'lat': 50.56109, 'lon': 8.50495}}], 'overallOfficials': [{'name': 'Winfried Wedekind, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Neurocoed AG, Sportparkstr. 9, D-35578 Wetzlar, Germany'}, {'name': 'Wilfried Dimpfel, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Neurocode AG, Sportparkstr. 9, D-35578 Wetzlar, Germany'}, {'name': 'Anja Braschoss, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pascoe Pharmazeutische Praeparate GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pascoe Pharmazeutische Praeparate GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Anja Braschoss, MD', 'oldOrganization': 'PASCOE pharmazeutische Praeparate GmbH'}}}}