EASYlight study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Reinier de Graaf Groep

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Trial duration

14 Feb 2024 → ongoing

Decision date (initial)

2024-01-18

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Eurocept pharmaceuticals (only esketamine) · STIMAG grant

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

The primary aim of the EASYlight study is to assess the effect of 8 hour esketamine infusion versus placebo (saline) on the numeric rating scale score (NRS score) for chronic pelvic pain in patients with chronic pain associated with endometriosis.

Secondary objectives 7

1. Treatment experience
2. NRS scores for dysmenorrhea, dysuria, dyschezia, dyspareunia and chronic pelvic pain
3. Depressive symptoms
4. Quality of life
5. Pain coping and cognition
6. Work productivity
7. Health care utilization

Conditions and MedDRA coding

Endometriosis

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. All pre-menopausal women aged above 18 years
2. Women (endometriosis is a condition exclusive to females)
3. - Diagnosed with endometriosis (ultrasound, MRI or previous laparoscopic and/or diagnostic surgery) according to the #Enzian classification. This means that endometriosis is present in the following compartments: Rectovaginal space (minimal A1) and/or Sacrouterine ligaments, cardinal ligaments, pelvic sidewall (minimal B1) and/or Rectum (minimal C1) and/or Endometriosis of the intestines, diaphragm and/or Adenomyosis (according to the morphological uterus sonographic assessment (MUSA) or evident adenomyosis on the MRI) and/or Peritoneal / superficial endometriosis (diagnosed laparoscopically and not treated during surgery).
4. -Mild to severe chronic pelvic pain (NRS scale >= 6). The 11-point NRS scale ranges from ‘0’ representing no pain to ‘10’ representing the worst pain imaginable.
5. -Resistant to current recommended lines of analgesics (paracetamol, NSAIDs)
6. -Usage of strong opioids must not have been prescribed or otherwise have been discontinued for more than 1 week.
7. -An indication for endometriosis resection surgery or on the waiting list for surgical treatment
8. -Ability to understand the patient information letter and to give oral and written informed consent
9. -No alteration in the utilization of hormonal therapy ≤1 months prior to inclusion.

Exclusion criteria 21

1. - Pain score <6 out of 10 (NRS) for chronic pelvic pain
2. - Endometriosis affecting the bladder and ureter
3. - Increased intracranial pressure
4. - Poorly regulated hypertension, >180/100mmHg at rest
5. - Patients with thyroid disease
6. - Patients with cancer
7. - History of psychiatric illness (schizophrenia, psychosis, delirium, manic depression)
8. - Serious medical disease (e.g., cardiovascular, renal , pulmonary or liver disease)
9. - Severe liver disease
10. - Patients with glaucoma
11. - Usage of strong opioid medication
12. - Usage of xanthine derivatives or ergometrine
13. - Unstable angina, heart failure, history of cerebral vascular accident (CVA)
14. - Patients suffering from an active infection
15. - Patients with epilepsy
16. - Patients trying to achieve pregnancy and or patients who are breastfeeding
17. - Not being able to answer questionnaires (in Dutch)
18. - Mentally incompetent (patients not able to make decisions that are in their best interests, this will be evaluated by their treating physician (e.g. patients with an intellectual disability or mental retardation))
19. -Alcohol or drug abuse
20. -Patient with a known (es)ketamine allergy
21. -Abnormal liver enzyme levels at baseline (ASAT, ALAT, GGT, AF, Bilirubin total), defined in protocol V4

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. NRS score for chronic pelvic pain 4 weeks after the 8 hour infusion treatment

Secondary endpoints 6

1. Pain scores (NRS scores for dysmenorrhea, dyschezia, dysuria, dyspareunia and chronic pelvic pain)
2. Treatment experience (including side-effects) (Bond&Ladder questionnaire, Bowdle questionnaire, treatment experience rating (on a scale of 0-10)
3. Depressive symptoms (HADS)
4. Quality of life (EHP-30, EQ-5D-5L)
5. Cost-effectiveness (adjusted iPCQ, adjusted iMCQ)
6. Pain coping and cognition (PCCL)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Reinier de Graaf Groep

Sponsor organisation

Reinier de Graaf Groep

Address

Reinier De Graafweg 5

City

Delft

Postcode

2625 AD

Country

Netherlands

Scientific contact point

Organisation

Reinier de Graaf Groep

Contact name

Maaike de Leeuw

Public contact point

Organisation

Reinier de Graaf Groep

Contact name

Maaike de Leeuw

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

2 submissions — initial application plus substantial / non-substantial modifications