Nor-Cactus

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Diakonhjemmet Sykehus AS

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10], Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

8 Apr 2022 → ongoing

Decision date (initial)

2024-06-19

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

South-Eastern Norway Regional Health Authority

External identifiers

EU CT number

2024-511223-34-00

EudraCT number

2021-004756-42

ClinicalTrials.gov

NCT05306548

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis, Safety, Efficacy, Therapy

Assess if the success-rate of a treatment strategy with initial ultrasound-guided injection therapy with up to two injections, scheduled clinical assessment of treatment effect, and subsequent surgery if needed, is non-inferior to a treatment strategy where surgery is the primary treatment, evaluated 12 months after the first intervention

Secondary objectives 7

1. Estimate if the success-rate of the injection strategy is non-inferior to primary surgery in a shorter or longer perspective
2. Estimate success rate of one and two steroid injections
3. Assess the proportion of patients with need for secondary surgery in the injection arm
4. To evaluate cost effectiveness and health economic impact of the treatment strategies
5. To compare the safety of the two study-arms
6. To assess predictors of patient outcomes
7. To evaluate the environmental impact of the study interventions and treatment strategies

Conditions and MedDRA coding

Carpal Tunnel Syndrome

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Adult (≥18 years of age)
2. Patient history indicating CTS (see section 2.2.1 in protocol)
3. Neurophysiological examination performed within 6 months
4. Diagnosis of CTS based on: a. Classic/probable or possible symptoms, and neurophysiological findings consistent with CTS Or, in case of normal neurophysiological findings: b. Classic/probable symptoms and positive physical exam findings and/or nighttime symptoms
5. Mild to moderate symptoms (intermittent, interfering with everyday life, and/or disturb sleep)

Exclusion criteria 16

1. Previous CTS surgery or corticosteroid injection in the carpal tunnel in the relevant hand
2. Diagnosis of severe CTS, based on history and examination indicating severe CTS with constant symptoms including pain, loss of sensibility, dexterity or reduced temperature sensation, weakness of thumb abduction and opposition, or atrophy of thenar musculature. Disappearance of pain may indicate permanent sensory loss.
3. History suggesting underlying causes of CTS e.g. inflammatory wrist arthritis and/or flexor tenosynovitis
4. Previous significant trauma or fracture, deformity or tumor in the wrist or hand in the relevant hand
5. Presence of conditions affecting a normal nerve function e.g. cervical disc herniation, polyneuropathy or previous nerve injury
6. Major co-morbidities, such as severe malignancies, severe or uncontrolled infections, uncontrollable hypertension, severe cardiovascular disease (NYHA class III or IV) and/or Side 29 av 127 severe respiratory diseases, severe renal failure, active ulcus ventriculi, leukopenia and/or thrombocytopenia
7. Severe psychiatric or mental disorders
8. Local infection or wound in the affected hand/wrist
9. Any other medical condition that according to the treating physician and/or local guidelines makes adherence to treatment protocol impossible
10. Inadequate birth control (Only applicable for women of childbearing potential. Refer to protocol section 10.4 for definitions and contraception guidance), pregnancy (Only applicable for women of childbearing potential. Refer toprotocol section 8.3.5.), and/or breastfeeding (current at screening or planned within the duration of the study)
11. Known hypersensitivity to the interventional drug (Triamcinolone Hexacetonide (Lederspan) or Triamcinolone Acetonide (Kenacort-T)), or any of the excipients (sorbitol, polysorbate or benzyl alcohol)
12. Concomitant therapy with CYP3A-inhibitors or digitalis glycosides
13. Patients vaccinated or immunized with live virus vaccines within 2 weeks of treatment
14. Alcohol or other substance abuse
15. Language barriers
16. Other factors which make adherence to study protocol impossible

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Successful treatment outcome after one year, defined as attainment of Boston Carpal Tunnel Questionnaire Symptom Score ≤ 1.5

Secondary endpoints 7

1. Successful treatment result (as defined above) after 3, 6 and 24 months
2. Successful treatment result after one injection, and after two injections
3. Patients in the injection arm who have undergone surgery after 3 weeks, 3, 6, 12 and 24 months
4. Work performance/participation and health care utilization as outlined in section 8.8 at each, or a combination, of time points.
5. Adverse events throughout the study
6. Patient-reported measures of symptoms and function, ultrasound and NCS measures as outlined in section 8.1 at each time point
7. Emitted CO2-equivalents per treatment strategy pathway.

Investigational products

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

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Diakonhjemmet Sykehus AS

Sponsor organisation

Diakonhjemmet Sykehus AS

Address

Diakonveien 12

City

Oslo

Postcode

0370

Country

Norway

Scientific contact point

Organisation

Diakonhjemmet Sykehus AS

Contact name

Coordinator

Public contact point

Organisation

Diakonhjemmet Sykehus AS

Contact name

Coordinator

Third parties 1

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Country notifications

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

Application history

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