Kliniske forsøg Nct side

Summary
EudraCT Number:2006-002757-72
Sponsor's Protocol Code Number:NEOSH101-CLIN-AGA003
National Competent Authority:Germany - BfArM
Clinical Trial Type:EEA CTA
Trial Status:Completed
Date on which this record was first entered in the EudraCT database:2006-09-26
Trial results
Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL
A. Protocol Information
A.1Member State ConcernedGermany - BfArM
A.2EudraCT number2006-002757-72
A.3Full title of the trial
A Phase 2 Multicenter, Randomized, Placebo- and Comparator Controlled, Double-Blind Parallel Group Study to Evaluate the Safety and Efficacy of Topical NEOSH101 in the Treatment of Androgenetic Alopecia in Men
A.4.1Sponsor's protocol code numberNEOSH101-CLIN-AGA003
A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorNeosil Inc.
B.1.3.4CountryUnited States
B.3.1 and B.3.2Status of the sponsorCommercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation No
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameNEOSH101
D.3.2Product code NEOSH101
D.3.4Pharmaceutical form Cutaneous solution
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPCutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2Current sponsor codeNEOSH101
D.3.9.3Other descriptive nameC-3900, PSI, Proteasome Inhibitor 1
D.3.10 Strength
D.3.10.1Concentration unit % percent
D.3.10.2Concentration typeequal
D.3.10.3Concentration number2.0
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 2
D.1.2 and D.1.3IMP RoleComparator
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Rogaine Extra Strength for Men
D.2.1.1.2Name of the Marketing Authorisation holderPfizer
D.2.1.2Country which granted the Marketing AuthorisationUnited States
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameRogaine Extra Strength for Men
D.3.4Pharmaceutical form Cutaneous solution
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPCutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNMinoxidil
D.3.10 Strength
D.3.10.1Concentration unit % percent
D.3.10.2Concentration typeequal
D.3.10.3Concentration number5.0%
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
D.8 Placebo: 1
D.8.1Is a Placebo used in this Trial?Yes
D.8.3Pharmaceutical form of the placeboCutaneous solution
D.8.4Route of administration of the placeboCutaneous use
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
The study will be performed in male subjects with androgenetic alopecia, Norwood -Hamilton grades III - IV.
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 8.1
E.1.2Level LLT
E.1.2Classification code 10001760
E.1.2Term Alopecia
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
The primary objective is to evaluate the efficacy of twice-daily (bid) topical application of two doses of NEOSH101, for 16 weeks, on hair growth in men with androgenetic alopecia
E.2.2Secondary objectives of the trial
The secondary objectives are:
· To evaluate the safety of bid topical application of NEOSH101 for 16 weeks in men with androgenetic alopecia
· To make a preliminary comparison of the efficacy of NEOSH101 compared to 5% minoxidil treatment or vehicle placebo treatment, at 16 weeks
· To make a preliminary evaluation of the clinical pharmacokinetic profile of NEOSH101
· To make a preliminary evaluation of the duration of treatment effect at 12 weeks following cessation of 16 weeks of treatment
· Global assessment of hair growth by the investigator at 16 weeks
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
All of the following criteria have to be met for inclusion of a subject in the study:
•Caucasian men, aged 18 to 49 years;
• written informed consent obtained.


•Norwood/Hamilton grades III - IV, androgenetic alopecia (with thinning hair in the vertex area);
•healthy skin on the scalp;
•the physical examination must be without disease findings unless the investigator considers a physical examination abnormality to be irrelevant to the outcome of the study;
•normal clinical laboratory values unless the investigator considers an abnormality to be clinically irrelevant for the study participation;
•subjects either not of reproductive potential (e.g. vasectomy, documented infertility) or use adequate contraception, defined in men as a condom + spermicidal gel or foam or abstinence throughout the duration of the study.
E.4Principal exclusion criteria
concomitant dermatologic or medical condition(s) which may interfere with the investigator’s ability to evaluate the subject’s response to the study drug;
•previous surgical correction of scalp hair loss;
•hair loss due to disease/drug treatment;
•subjects whose scalp is occluded regularly, eg, hair loss necessitates the wearing of a wig or hat or the subject has to wear a hat for work;
•clinically significant abnormalities in clinical chemistry, haematology or urinalysis results;
•evidence of drug or alcohol abuse;
••treatment with a systemic or locally acting medication which may interfere with the study objectives, such as minoxidil treatment in the 6 months prior to study day 1, finasteride treatment in the 12 months prior to study day 1, or treatment with other investigational hair growth products in the 6 months prior to study day 1;
•previous treatment with NEOSH101;

•donation of blood or plasma to a blood bank or in a clinical study (excluding a Screening visit) within 30 days of study day 1;
•major surgery within 1 month of study day 1;
•history of malignancy not in remission for at least 5 years excluding basal cell carcinoma and nonperiorificial squamous cell carcinoma of the skin;
•history of untreated or poorly-controlled hypertension, myocardial infarction, or other clinically significant cardiovascular disease history;
•another active intercurrent infection or any poorly controlled medical condition;
•a history of hypersensitivity or allergic reactions to minoxidil, propylene glycol or ethanol or to any ingredient in the vehicle formulation, or to hair dye used to tattoo the treatment area;
•if the subjects have a partner who is pregnant or lactating, or who intends to become pregnant during the study period;
•if the subjects are institutionalized because of legal or regulatory order;
•any reason which, in the opinion of the investigator, interferes with the ability of the subject to participate in, or complete, the trial or which places the subject at undue risk.
E.5 End points
E.5.1Primary end point(s)
The primary endpoint is the change of hair density
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis Information not present in EudraCT
E.6.2Prophylaxis Information not present in EudraCT
E.6.3Therapy Information not present in EudraCT
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic Yes
E.6.7Pharmacodynamic Information not present in EudraCT
E.6.8Bioequivalence Information not present in EudraCT
E.6.9Dose response No
E.6.10Pharmacogenetic Information not present in EudraCT
E.6.11Pharmacogenomic Information not present in EudraCT
E.6.12Pharmacoeconomic Information not present in EudraCT
E.6.13Others Information not present in EudraCT
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) Information not present in EudraCT
E.7.1.1First administration to humans Information not present in EudraCT
E.7.1.2Bioequivalence study Information not present in EudraCT
E.7.1.3Other Information not present in EudraCT
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) Yes
E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open No
E.8.1.3Single blind No
E.8.1.4Double blind Yes
E.8.1.5Parallel group Yes
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) Yes
E.8.2.2Placebo Yes
E.8.2.3Other No
E.8.3 The trial involves single site in the Member State concerned No
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.4.1Number of sites anticipated in Member State concerned2
E.8.5The trial involves multiple Member States No
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA No
E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
E.8.7Trial has a data monitoring committee No
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years
E.8.9.1In the Member State concerned months11
E.8.9.1In the Member State concerned days
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero Information not present in EudraCT
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
F.1.1.3Newborns (0-27 days) Information not present in EudraCT
F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
F.1.1.5Children (2-11years) Information not present in EudraCT
F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
F.1.2Adults (18-64 years) Yes
F.1.3Elderly (>=65 years) No
F.2 Gender
F.2.1Female No
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations No
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception No
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state180
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
A treatment after end of the study is not planned.
The period of observation for adverse events extends from the time were the subject gives informed consent until he undergoes a final examination as part of the study, including periods before and after an active treatment phase during which no drug or other treatments must be given Adverse events occurring after the end of the study must be reported if the investigator considers there is a causal relationship with the study preparation.
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2006-11-30
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2006-09-27
P. End of Trial
P.End of Trial StatusCompleted
P.Date of the global end of the trial2007-10-25

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