BridgeMD
CHRONDI
EU CTIS ID: 2024-513595-17-00
What this study is testing
To evaluate the efficacy of ODM-111 in the treatment of chronic pain due to diabetic peripheral neuropathy (DPN).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed informed consent (IC) for participation in the trial.
- Males and females 18 to 80 years of age at screening visit
- Body mass index (BMI) 18-45 kg/m2 at screening visit.
- 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.
- 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.
- 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.
You likely can't join if
- 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.
- Active infection.
- Females who are pregnant or lactating at screening or planning to become pregnant within 1 month from the last dose of study treatment.
- HbA1c >10% or >86 mmol/mol at screening.
- Peripheral neuropathy caused by a condition other than diabetes mellitus.
- 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.
See the full eligibility criteria
Who can join
- Signed informed consent (IC) for participation in the trial.
- Males and females 18 to 80 years of age at screening visit
- Body mass index (BMI) 18-45 kg/m2 at screening visit.
- 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.
- 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.
- 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.
- 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.
- Douleur Neuropathique 4 (DN4) score of ≥[blinded information] at the screening visit.
- 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.
What rules you out
- 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.
- Active infection.
- Females who are pregnant or lactating at screening or planning to become pregnant within 1 month from the last dose of study treatment.
- HbA1c >10% or >86 mmol/mol at screening.
- Peripheral neuropathy caused by a condition other than diabetes mellitus.
- 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.
- 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.
- Chronic inflammatory disease
- Diagnosis of long COVID (including self-diagnosis by participant
- Known hypersensitivity to the active substance or to any of the excipients of the study treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; New Zealand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.