Clinical Trials Register

Summary
EudraCT Number:	2017-003458-18
Sponsor's Protocol Code Number:	IRL790C003
National Competent Authority:	UK - MHRA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-09-27
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

UK - MHRA

A.2

EudraCT number

2017-003458-18

A.3

Full title of the trial

A randomised, double-blind, placebo-controlled, phase IIA study evaluating the efficacy and tolerability of IRL790 in Parkinson's disease dyskinesia

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A clinical trial to study the effects of IRL790 in Parkinson's disease dyskinesia

A.4.1

Sponsor's protocol code number

IRL790C003

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Integrative Research Laboratories AB (IRLAB)
B.1.3.4	Country	Sweden
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	Integrative Research Laboratories AB (IRLAB)
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Integrative Research Laboratories AB (IRLAB)
B.5.2	Functional name of contact point	Clinical Trials Information
B.5.3	Address:
B.5.3.1	Street Address	Arvid Wallgreen backe 20
B.5.3.2	Town/ city	Göteborg
B.5.3.3	Post code	413 46
B.5.3.4	Country	Sweden
B.5.4	Telephone number	+46(0)707601691
B.5.6	E-mail	joakim.tedroff@irlab.se

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	IRL790
D.3.2	Product code	IRL790
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
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	IRL790
D.3.9.1	CAS number	1403894-72-3
D.3.9.2	Current sponsor code	IRL790
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	2.5
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)	No
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	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
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	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
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	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

Parkinson's disease dyskinesia

E.1.1.1

Medical condition in easily understood language

Parkinson's disease dyskinesia refers to a group of involuntary movement disorders. Dyskinesia can be anything from a slight tremor of the hands to an uncontrollable movement of the body.

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10061536
E.1.2	Term	Parkinson's disease
E.1.2	System Organ Class	10029205 - Nervous system disorders

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 efficacy of IRL790 in Parkinson's disease dyskinesia

E.2.2

Secondary objectives of the trial

To evaluate the effects of IRL790 on core symptoms of Parkinson's disease.

To evaluate the pharmacokinetics, safety and tolerability of IRL790 in patients with Parkinson's disease dyskinesia

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female ≥18 and ≤79 years of age.

2. Signed a current Ethics Committee approved informed consent form.

3. Parkinson's disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria.

4. Waking day dyskinesia of ≥25% determined as a score of ≥2 as per Question 4.1 of the MDS-UPDRS.

5. On a stable regimen of antiparkinson medications for at least 30 days prior to screening, including a levodopa preparation administered not less than three times daily and willing to continue the same doses and regimens during study participation. Rescue medication such as Madopar dispersable and Apomorphine injections are allowed.

6. Taking a maximum of eight regular levodopa intakes per day, excluding bedtime and night time levodopa.

7. Any other current and allowed prescription/non-prescription medications and/or nutritional supplements taken regularly must have been at a stable dose and regimen for at least 30 days prior to screening and the patient must be willing to continue the same doses and regimens during study participation (this criterion does not apply to medications that are being taken pre-study only on an as-needed basis).

8. Patients must be willing and able to avoid direct exposure to sunlight from day 1 to day 28.

9. Able to complete at least one valid 24-hour patient diary at Visit 1.

E.4

Principal exclusion criteria

1. History of neurosurgical intervention related to Parkinson's disease (e.g. deep brain stimulation).

2. Treatment with pump delivered antiparkinsonian therapy (i.e. subcutaneous apomorphine or levodopa/carbidopa intestinal infusion).

3. History of seizures within two years prior to screening.

4. History of stroke or transient ischemic attack (TIA) within two years prior to screening.

5. History of cancer within five years prior to screening, with the following exceptions: adequately treated non-melanomatous skin cancers, localised bladder cancer, non-metastatic prostate cancer or in situ cervical cancer.

6. Presence of cognitive impairment, as evidenced by a Mini-Mental Status Examination (MMSE) score of less than 24 during screening.

7. A Hoehn and Yahr stage of five.

8. Any history of a significant heart condition, or cardiac arrhythmias within the past 5 years, any repolarisation deficits or any other clinically significant abnormal ECG as judged by the Investigator.

9. Severe or ongoing unstable medical condition including a history of poorly controlled diabetes; obesity associated with metabolic syndrome; uncontrolled hypertension; cerebrovascular disease, or any form of clinically significant cardiac disease; clinically significant symptomatic orthostatic hypotension; clinically significant hepatic disease;, renal failure, or a abnormal renal function (definition of abnormal renal function is creatinine clearance <45 ml/min (calculated according to the Cockcroft-Gault formula).

10. Any history of a neurological or other than Parkinson’s disease or a psychiatric disorder, including history of DSM IV diagnosed major depression, or psychosis. Patients with illusions or hallucinations with no loss of insight will be eligible Patients with mild depression who are well controlled on a stable dose of an antidepressant medication for at least 4 weeks before screening will be eligible.

11. Enrolment in any other clinical study involving medication, medical devices or surgical procedures, current or within three months prior to screening visit, or previous participation in the present study. Patients enrolled in non-interventional clinical trials will be eligible.
12. Drug and/or alcohol abuse

13. History of severe drug allergy or hypersensitivity

14. If female, is pregnant or lactating, or has a positive pregnancy test result pre-dose

15. Patients unwilling to use two forms of contraception (one of which being a barrier method see Section 7.3) 90 days for men and 30 days for women after last IMP dose

16. Any planned major surgery within the duration of the study

17. Any other condition or symptoms preventing the patient from entering the study, according to the Investigator’s judgement

E.5 End points

E.5.1

Primary end point(s)

Change in the Unified Dyskinesia Rating Scale (UDysRS) total score

E.5.1.1

Timepoint(s) of evaluation of this end point

UDysRS measured at Baseline (Day 1) and week 4

E.5.2

Secondary end point(s)

Secondary Endpoints
Change in Total Objective Score (III, IV) of the UDysRS

Change in daily "OFF" time as assessed with patient diaries from run-in to Visit 4.

Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score of part III (motor), and sum score of Questions 4.1 and 4.2 in part IV

Exploratory Endpoints
Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part I (total score), part II (total score) and part IV (total score)

Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Question 1.2 (Hallucinations and Psychosis)

Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Question 1.6 (Features of dopamine dysregulation syndrome)

Clinician's Global Impression of Change in overall PD symptoms

Daily "ON" time with troublesome dyskinesia as assessed with patient diaries from run-in to Visit 4.

Change in “ON” time as assessed by patient completed 24-hour diaries, from run-in to Visit 4 (Day 28).

E.5.2.1

Timepoint(s) of evaluation of this end point

Secondary Endpoints
Change in Total Objective Score (III, IV) of UDysRS from Day 1 to Week 4

Change in daily "OFF" time as assessed with patient diaries from 28 to 7 days prior to Day 1 and Week 4.

Change in MDS-UPDRS total score of part III and sum of score of Questions 4.1 and 4.2 in part IV from Day 1 to Week 4

Exploratory Endpoints
MDS-UPDRS Part I, part II and Part IV total scores from Day 1 to Week 4

MDS-UPDRS Question 1.2 from Day 1 to Week 4

MDS-UPDRS Question 1.6 from Day 1 to Week 4

Clinician's Global Impression of Change in overall PD symptoms from Day 1 to Week 4.

Daily "ON" time assessed by patient diaries from 28-7 days prior to Day 1 to Visit 4.

Change in “ON” time as assessed by patient completed 24-hour diaries, from run-in to Visit 4 (Day 28).

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

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

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)

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

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.8.2.4

Number of treatment arms in the trial

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.8.4.1

Number of sites anticipated in Member State concerned

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

E.8.7

Trial has a data monitoring committee

Yes

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

LVLS

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

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

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

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

F.3.3.1

Women of childbearing potential not using contraception