Clinical Trials Register

Summary
EudraCT Number:	2007-001060-80
Sponsor's Protocol Code Number:	AB/PD/21
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2007-10-09
Trial results	View 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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2007-001060-80

A.3

Full title of the trial

A multicenter, parallel-group, double-blind, randomized, placebo-controlled, increasing-dose study, to evaluate preliminarily the clinical effects, the safety and tolerability of ABIO 08/01, in patients suffering from panic disorder.

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

AB/PD/21

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	ABIOGEN PHARMA
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	BTG 1640
D.3.2	Product code	ABIO 08/01
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	ABIO 08
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	Information not present in EudraCT
D.3.11.8	Extractive medicinal product	Information not present in EudraCT
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Panic disorder

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	6.1
E.1.2	Level	PT
E.1.2	Classification code	10033666

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the effects on PDSS average item score after 8 weeks of double-blind treatment.

E.2.2

Secondary objectives of the trial

- To evaluate the effects on PDSS average item score during the 8 week double-blind treatment period and at the end of the 1 week follow-up period.

- To evaluate the proportion of patients who respond to treatment (response is defined as ≥ 50% decrease in PDSS average item score) during the 8 week double-blind treatment period and at the end of the 1 week follow-up period.

- To evaluate the effects on CGI, HAM-A, PAS-SR, PAS (Bandelow) during the 8 week double-blind treatment period and at the end of the 1 week follow-up period.

- To evaluate the safety and tolerability of ABIO 08/01 over the whole study period.

- To assess the compliance of the patient to the treatment.

E.2.3

Trial contains a sub-study

Information not present in EudraCT

E.3

Principal inclusion criteria

 Caucasian males between 18 and 60 years of age on the day of the screening visit.

 Patients affected by panic disorders (including naïve patients) according to DSM-IV, evaluated with SCID-P.

 PDSS (Panic Disease Severity Scale) total score > 12.

 Patients are required to have screening and baseline total scores of at least 20 on the Hamilton Rating Scale for Anxiety (HAM-A) and scores of at least 2 on items 1 (anxious mood) and 2 (tension). However, patients who had a reduction of at least 20% in the HAM-A total score between the screening visit and the baseline visit are not eligible.

 Willing and able to understand and sign an Informed Consent form.

E.4

Principal exclusion criteria

 History of alcohol or drug abuse in the last year.

 Positive toxicological urinary screening.

 Smokers of more than 20 cigarettes/day.

 History of allergic response to drugs.

 Participation to a previous clinical trial within the past 3 months.

 Patients with coexisting primary MDD, evaluated by means of HAM-D.

 History or presence of any psychotic illness, bipolar disorder, antisocial personality or other severe Axis II disorder, or if they had a clinically significant psychiatric disturbances other than panic disorders.

 Patients at immediate risk of committing harm to self or others.

 Use of any investigational drug or procedure, any antipsychotic, antiepileptic antihistaminic drug, or the regular use of benzodiazepines or hypnotics within 30 days from baseline; or any use of antidepressants (including TCAs) within 14 days (fluoxetine within 30 days) or any episodic use of an anxiolytic within 7 days before baseline visit.

 Electroconvulsive therapy in the year prior to entry.

 Treatment with any known enzyme inhibiting or inducing agents (barbiturates, phenothiazines, etc.) within the past 4 weeks.

 Patients with treatment resistant panic disorder (defined as lack of response to two different effective drugs both used over six weeks at therapeutic dosages).

 Positive to HIV test and/or Hepatitis B or C tests.

 Unwilling to give written informed consent.

 Drinking excessive amounts of tea, cacao, coffee and/or beverages containing caffeine (> 5 cups/day) or wine (> 0,5 l/day or equivalents for spirits).

 In the judgment of the Clinical Investigator subjects likely to be not compliant or uncooperative during the study.

 Lack of an appropriate family support.

 Patients with clinically significant diseases other than the disease under study. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or may influence the results of the trial or the patient’s ability to participate in the study.

 Patients with a history of clinically significant liver disease (defined as SGOT or SGPT> 3 times UNL), renal disease (defined as a serum creatinine >2.0 mg/dl) or clinical history of major cardiovascular disease. Severe neurological disease which may impair the results. The only patients with known prior malignant disease who are eligible are those with cured skin cancer (excluding melanoma).

 Patients who do not wish to discontinue current, ineffective treatment for panic disorder.

 Patients who have undergone psychotherapy during the previous 6 months from the study entry.

E.5 End points

E.5.1

Primary end point(s)

Panic Disorder Severity Scale (PDSS)

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Information not present in EudraCT

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Information not present in EudraCT

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

Information not present in EudraCT

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.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	No
F.2 Gender
F.2.1	Female	No
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Information not present in EudraCT
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Information not present in EudraCT
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	110

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2007-10-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2007-09-27

P. End of Trial
P.	End of Trial Status	Completed

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