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Summary
EudraCT Number:	2004-003975-35
Sponsor's Protocol Code Number:	750201.01.014
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:	2004-12-13
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

A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2004-003975-35

A.3

Full title of the trial

Multi-center, double-blind, placebo-controlled, randomized phase III study to prove the efficacy, safety and tolerability of Lavender oil WS 1265 (Lavandula angustifolia) in patients with restlessness and sleep disturbances

A.4.1

Sponsor's protocol code number

750201.01.014

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	Dr. Willmar Schwabe GmbH & Co. KG
B.1.3.4	Country	Germany
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	Information not present in EudraCT
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	Lavendelöl WS 1265
D.3.4	Pharmaceutical form	Capsule*
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.3.8	INN - Proposed INN	Lavender oil Ph. Eur.
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	80
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
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	Yes
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	Capsule*
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

restlessness and sleep disturbances

MedDRA Code for RESTLESSNESS: 10038743
MedDRA Code für SLEEP DISTURBANCES: 10040997

MedDRA Classification

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 prove the clinical efficacy of Lavender oil WS 1265 in the treatment of patients with restlessness and sleep disorders

E.2.2

Secondary objectives of the trial

To compare Lavender oil WS 1265 and placebo in responder rates whereby responders are defined as:
- At least 50% reduction of the HAM-A total score between baseline and week 10 or 25% reduction of the PSQI total score between baseline and week 10;
- Total score of the HAM-A below 10 points at week 10 or total score of the PSQI below 6 points at week 10.

E.2.3

Trial contains a sub-study

Information not present in EudraCT

E.3

Principal inclusion criteria

1. Present restlessness and sleep disorders.

2. Age: 18 to 65 years.

3. Out-patient treatment by a general practitioner or specialized physician.

4. Severity of anxiety and restlessness symptoms for the inclusion in the wash-out and into the acute treatment phase:
HAM-A total score more or equal than 18 and
Item 2 „tension“ more or equal than 2 and
Item 4 „insomnia“ more or equal than 2.

These criteria have to be met at Visits 1 and 2.

5. Severity of sleep disorders for the inclusion in the wash-out and into the acute treatment phase:
PSQI total score more or equal than 6.

This criterion has to be met at Visits 1 and 2.

6. Written informed consent in accordance with the legal requirement.

7. Readiness and ability on the part of the patient to comply with the physician´s instructions and to fill in the self-assessment scales.

8. Negative pregnancy test within 5 days before study start in females of childbearing potential (non-childbearing potential is defined as post-menopause for at least one year or surgical sterilization or hysterectomy at least three months before study start).

9. Use of adequate contraception by female with childbearing potential (intra-uterine devices, oral or injectable contraception).

E.4

Principal exclusion criteria

1. A decrease of 25% or more of the HAM-A total score during the screening phase.

2. Any clinically important psychiatric or neurological diagnose within 6 month before the study, except anxiety disorders, mild to moderate unipolare depressive disorders, somatoform disorders, neurasthenia, personality disorders, primary insomnia.

3. Risk of suicide.

4. History or evidence of alcohol and/or substance abuse or dependence, particularly of sedatives, hypnotics and anxiolytics. (303.90; 305.00; 304.10; 305.40)

5. Shizophrenia.

6. Current use of other psychotropic drugs within 30 days of baseline visit.*

7. History of hypersensitivity to Lavender preparations.

8. Any unstable acute medical disorder.

9. Unacceptability to discontinue, or likelihood to need medication during the study that is prohibited as concomitant treatment (specified in section 6). The following medication is not allowed during the study:
- any psychotropic drugs including benzodiazepines, non-benzodiazepines (zopiclone, zolpidem), neuroleptics, tranquilizer, antidepressives, antiepileptics, antihistaminics
- long-term prophylactic treatment (e.g. lithium, carbamazepine)
- central-acting antihypertensive medication
- antiparkinson medication
- phyto-anxiolythics
- muscle relaxants
- analgetics of opiate type
- anesthetics
- barbiturates
- nootropics.

10. Non-medical psychiatric treatment (e.g., specific standardized psychotherapy) during the course of the study.

11. Treatment with any other investigational drug in the last 12 weeks before screening.

12. Clinical significant abnormality of ECG and/or laboratory value(s).

13. Any abnormal baseline finding considered by the investigator to be indicative of conditions that might affect study results.

14. Pregnancy, lactation.

E.5 End points

E.5.1

Primary end point(s)

- change of HAM-A total score between baseline and week 10;
- change of PSQI total score between baseline and week 10.
(protocol section 12.2)

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

Yes

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

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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

the last visit of the last subject

(see also protocol sections 10.1 - 10.3)

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

Information not present in EudraCT

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

Information not present in EudraCT

F.1.1.3

Newborns (0-27 days)

Information not present in EudraCT

F.1.1.4

Infants and toddlers (28 days-23 months)

Information not present in EudraCT

F.1.1.5

Children (2-11years)

Information not present in EudraCT

F.1.1.6

Adolescents (12-17 years)

Information not present in EudraCT

F.1.2

Adults (18-64 years)

Yes

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2004-12-13.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Information not present in EudraCT

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

156

F.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

156

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)

No special treatment planned after the subject has ended the participation in the trial.

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

2005-05-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2005-03-03

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2006-06-23

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