Chrondi

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Orion Corporation

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

completed 28 Oct 2024

Decision date (initial)

2024-10-21

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Others

To evaluate the efficacy of ODM-111 in the treatment of chronic pain due to diabetic peripheral neuropathy (DPN).

Conditions and MedDRA coding

CHRONIC PAIN DUE TO DIABETIC PERIPHERAL NEUROPATHY

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

"Clinical data sharing, including IPD sharing, for this trial will follow the Clinical Data Sharing Policy of the Sponsor (Orion Corporation). Further information can be found at https://www.orion.fi/en/sustainability/ethical-business/research-development-ethics-policy/sharing-clinical-data/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Signed informed consent (IC) for participation in the trial.
2. Males and females 18 to 80 years of age at screening visit
3. Body mass index (BMI) 18-45 kg/m2 at screening visit.
4. Type 1 or Type 2 diabetes of at least 6 months duration with optimised and stable glycaemic control during the 3 months prior to screening.
5. A diagnosis of painful diabetic peripheral neuropathy (DPN) with pain for at least 6 months before the screening visit that is primarily in the lower extremities.
6. An average pain intensity of ≥[blinded information] on the 11-point (0-10) numerical rating scale (NRS) in the lower extremities during the past 24 h at screening and at baseline.
7. A weekly average of daily pain intensity on the 11-point (0-10) numerical rating scale (NRS) at baseline, based on daily assessments over at least 5 of the 7 consecutive days preceding the baseline visit.
8. Douleur Neuropathique 4 (DN4) score of ≥[blinded information] at the screening visit.
9. Female participants with fertile male partners and male participants with female partners of child-bearing potential must adhere to a highly effective form of contraception (e.g. combined or progestogen only hormonal contraceptives associated with inhibition of ovulation, intrauterine devices or intrauterine hormone-releasing system) if sexually active and not permanently sterilised, for females from 4 weeks before the first study treatment administration and for males from Day 1 until 3 months after the EOS visit. Additionally, women who are postmenopausal (1 year since last menstrual cycle) are considered not to be reproductive and can be included. For male participants, sperm donation is not allowed until 3 months after the EOS visit.

Exclusion criteria 10

1. A predictable poor compliance or inability to understand and comply with protocol requirements, instructions and protocol-stated restrictions or to communicate well with the investigator.
2. Females who are pregnant or lactating at screening or planning to become pregnant within 1 month from the last dose of study treatment.
3. HbA1c >10% or >86 mmol/mol at screening.
4. Peripheral neuropathy caused by a condition other than diabetes mellitus.
5. Concomitant pain conditions (i.e., low back pain, radiculopathy, bone, and musculoskeletal disorders) which may impair self-assessment of pain due to diabetic peripheral neuropathy.
6. Use of analgesic treatment during the trial (from at least 10 days before the baseline visit until the last treatment visit), excluding the following: a. Gabapentin (up to 1800 mg daily), pregabalin (up to 300 mg daily), or duloxetine (up to 60 mg daily); only one of these preparations per participant is allowed and the dose must have been stable for ≥3 months prior to trial entry and will be kept stable for the study treatment period b. Acetylsalicylic acid for cardiovascular reasons, stable dosing up to 325 mg daily c. Paracetamol as rescue analgesia, up to 3 g daily as needed.
7. Chronic inflammatory disease
8. Diagnosis of long COVID (including self-diagnosis by participant
9. Known hypersensitivity to the active substance or to any of the excipients of the study treatment.
10. Active infection.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary efficacy endpoint is the change from baseline to week 6 in the weekly average of daily pain intensity (average over the previous 24 hours) on the 11-point numeric rating scale (NRS), as reported in the daily eDiary.

Investigational products

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

Test 2

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Orion Corporation

Sponsor organisation

Orion Corporation

Address

P. O. Box 65

City

Espoo

Postcode

02101

Country

Finland

Scientific contact point

Organisation

Orion Corporation

Contact name

Clinical Study Director

Public contact point

Organisation

Orion Corporation

Contact name

Clinical Study Director

Third parties 4

Locations

5 EU/EEA countries · 36 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 154 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

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