Clinical Trials Register

Summary
EudraCT Number:	2022-002818-16
Sponsor's Protocol Code Number:	JM-010CS-OL
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2022-11-04
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

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A. Protocol Information

A.1

Member State Concerned

France - ANSM

A.2

EudraCT number

2022-002818-16

A.3

Full title of the trial

Open-Label Extension Study of JM-010 in Parkinson’s Disease Patients With Dyskinesia

A.3.1

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

Open-Label Extension Study of JM-010 in Parkinson’s Disease Patients With Dyskinesia

A.4.1

Sponsor's protocol code number

JM-010CS-OL

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	Contera Pharma A/S
B.1.3.4	Country	Denmark
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	Contera Pharma A/S
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Contera Pharma A/S
B.5.2	Functional name of contact point	Clinical Trials Information
B.5.3	Address:
B.5.3.1	Street Address	7. Sangdo-ro, Dongjak-gu
B.5.3.2	Town/ city	Seoul
B.5.3.3	Post code	06955
B.5.3.4	Country	Korea, Republic of
B.5.4	Telephone number	+8228288 069
B.5.6	E-mail	cp.e103@conterapharma.co.kr

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	JM-010
D.3.2	Product code	JM-010
D.3.4	Pharmaceutical form	Film-coated tablet
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	Buspirone hydrochloride
D.3.9.1	CAS number	33386-08-2
D.3.9.4	EV Substance Code	SUB00906MIG
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	4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Zolmitriptan
D.3.9.1	CAS number	139264-17-8
D.3.9.4	EV Substance Code	SUB00181MIG
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	0.8
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.IMP: 2
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	JM-010
D.3.2	Product code	JM-010
D.3.4	Pharmaceutical form	Film-coated tablet
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	Buspirone hydrochloride
D.3.9.1	CAS number	33386-08-2
D.3.9.4	EV Substance Code	SUB00906MIG
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	8
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Zolmitriptan
D.3.9.1	CAS number	139264-17-8
D.3.9.4	EV Substance Code	SUB00181MIG
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	0.8
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

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 Patients with Dyskinesia

E.1.1.1

Medical condition in easily understood language

Parkinson's Disease Patients with Dyskinesia

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	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10013113
E.1.2	Term	Disease Parkinson's
E.1.2	System Organ Class	100000004852

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 determine the safety and tolerability of JM-010 from Baseline to Week 48. Safety and tolerability will be assessed in relation to the following:
• Adverse events (AEs)
• Clinical laboratory evaluations
• 12-lead electrocardiogram (ECG) assessments
• Vital signs
• Columbia-Suicide Severity Rating Scale (C-SSRS)

E.2.2

Secondary objectives of the trial

The secondary objectives of this OLE study are as follows:
• To summarize the efficacy of JM-010 in change in clinical progression of PD from Baseline to Week 48 as measured by the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Parts I, II, and III
• To summarize the efficacy of JM-010 in change in dyskinesia from Baseline to Week 48 as measured by the MDS-UPDRS Part IV.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Group 1
Below are the eligibility criteria for subjects who are continuing directly into JM-010CS-OL without a time gap between their JM-010CS03 study and JM-010CS-OL study.
1. Is able to read, understand, and provide written, dated informed consent.
2. Is deemed likely to comply with study protocol and communicate with study personnel about AEs and other clinically important information.
3. Has completed study visits per protocol in a previous JM-010CS03 study.
4. Has ambulatory or ambulatory-aided (e.g., walker or cane) ability while ON, such that the subject can complete study assessments.
5. Has a knowledgeable and reliable caregiver/study partner, if appropriate, to accompany the subject to perform study visits and assist in completion of study instruments, as needed and allowed.
6. Wishes to continue taking JM-010, and the investigator deems continued administration to be necessary or appropriate.
France-specific criteria:
7. Is registered to a social security scheme or is a beneficiary of one

Group 2
Below are the eligibility criteria for subjects who participated in a previous JM-010CS03 study and will enter JM-010CS-OL study with a time gap.
A subject will be eligible for inclusion only if each of the following criteria are met:
1. Is able to read, understand, and provide written, dated informed consent.
2. Is deemed likely to comply with study protocol and communicate with study personnel about AEs and other clinically important information.
3. Has completed study visits per protocol in a previous JM-010CS03 study.
4. Has ambulatory or ambulatory-aided (e.g., walker or cane) ability while ON, such that the subject can complete study assessments.
5. Has a knowledgeable and reliable caregiver/study partner, if appropriate, to accompany the subject to perform study visits and assist in completion of study instruments, as needed and allowed.
6. Wishes to continue taking JM-010, and the investigator deems continued administration to be necessary or appropriate.
France-specific criteria:
7. Is registered to a social security scheme or is a beneficiary of on

E.4

Principal exclusion criteria

Group 1
1. Discontinued study drug in a previous JM-010 Dyskinesia efficacy study due to intolerable or unacceptable AEs considered to be related to JM-010.
2. Has other psychiatric (not including hallucinations due to side effects of dopamine therapy), neurological or behavioral disorders that in the opinion of the investigator may interfere with the conduct or interpretation of the study, including dementia, or subject who is considered violent.
3. Has a significant risk for suicidal behavior in the opinion of the investigator during the course of their participation in the study or
• At Screening Visit: the subject scores “yes” on items 4 or 5 in the Suicidal Ideation section of the C-SSRS with reference to a 6-month period prior to Screening Visit; or
• At Screening Visit: the subject has had 1 or more suicidal attempts with reference to a 2 year period prior to Screening Visit; or
• At Baseline Visit: the subject scores “yes” on items 4 or 5 in the Suicidal Ideation section of the C SSRS with reference to Screening Visit.
4. Has current seizure disorders (other than febrile seizures in childhood) requiring treatment with anti convulsants.
5. Has current evidence of clinically significant hematological, autoimmune, endocrine, cardiovascular, peripheral vascular, renal, severe liver failure, gastrointestinal disorder, or other known condition that would possibly interfere with the subject’s participation in the study and/or assessments.
6. Has orthostatic or symptomatic hypotension: a decrease of > 20 mm Hg in systolic blood pressure (SBP) and/or > 10 mm Hg in diastolic blood pressure (DBP) after at least 3 minutes standing compared to the previous supine blood pressure (BP) in 2 separate measurements and/or history or current episode of repeated hypotensive or vasovagal syncope.
7. Has known history or current episode of the following:
• Stroke or transient ischemic attack.
• Ischemic heart disease, coronary vasospasm (Prinzmetal’s angina), peripheral artery disease, or symptoms of ischemic heart disease or signs compatible with ischemic heart disease or New York Heart Association Functional Classification of Heart Failure Class III or IV within 2 years prior to screening.
• Uncontrolled hypertension.
• Any clinically significant ECG abnormalities, including any findings of abnormal ventricular conduction or rhythm other than isolated premature ventricular contractions or first degree atrioventricular block.
8. Planned participation in another interventional clinical trial.
9. Is a female who is pregnant (confirmed by laboratory testing), nursing, or is planning to become pregnant for the duration of study participation (from the Screening Visit through the completion of the final follow-up visit) or is a woman of childbearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner, and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of postmenopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea and are using 1 or more of the following acceptable methods of contraception.
• surgical sterilization
• hormonal contraception
• double-barrier methods
10. Anticipated need for treatment with restricted medication.
France-specific criteria:
11. Is a protected person and/or is a person who is subject to legal protection measures.
12. Is participating in another clinical trial.

Group 2
In addition to the exclusion criteria for Group 1, following exclusion criteria needs to be confirmed for Group 2.
1. Has undergone surgery for the treatment of PD (e.g., pallidotomy, deep brain stimulation, fetal tissue transplantation) or has undergone any other major brain surgery.
2. History of alcohol or substance dependence or abuse (as defined by Diagnostic and Statistical Manual, Fifth Edition [DSM 5]), within 12 months prior to Screening Visit.
3. Has any malignant disease or a history of neoplasms treated within the 5 years prior to the Screening Visit, other than carcinoma in situ of the cervix or basal cell carcinoma of the skin.
4. Has body mass index (BMI) ≤ 17.5 or ≥ 40.0 kg/m2, and total body weight < 45 kg.
5. Has evidence of active infection with hepatitis A, hepatitis B or hepatitis C by serology within 6 months.

E.5 End points

E.5.1

Primary end point(s)

Safety endpoints include the following:
1. AEs
2. Clinical laboratory evaluations
3. 12-lead ECG assessments
4. Vital signs
5. C-SSRS

E.5.1.1

Timepoint(s) of evaluation of this end point

week 0, week 12, week 24, week 36, week 48

E.5.2

Secondary end point(s)

Efficacy Endpoint
1. MDS-UPDRS combined scores (Parts I, II, and III) changes from Baseline to Week 24 and 48
2. MDS-UPDRS Part IV score changes from Baseline to Week 24 and 48
3. MDS-UPDRS Part IV (items 4.1 and 4.2 only) score changes from Baseline to Week 48

E.5.2.1

Timepoint(s) of evaluation of this end point

week 0, week 24, week 48

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

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

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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

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

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Korea, Republic of

France

Spain

Germany

Italy

E.8.7

Trial has a data monitoring committee

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

Last subject Last visit including Follow up visit (approximately 2 weeks following the last dose of study treatment)

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

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

Best standard of care at investigator's discretion

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

2022-12-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-12-01

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

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