Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
60
Countries
1
Sites
1
Complex Regional Pain Syndrome
The main objective is to compare the change in pain intensity from baseline to last week of fremanezumab treatment to placebo treatment in patients with CRPS.
Key facts
- Sponsor
- Aarhus University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 11 Dec 2023 → ongoing
- Decision date (initial)
- 2023-06-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The main objective is to compare the change in pain intensity from baseline to last week of fremanezumab treatment to placebo treatment in patients with CRPS.
Secondary objectives 1
- To assess pain relief and differences in clinical signs of the disease and function between the groups and if the effect can be predicted by CGRP biomarkers.
Conditions and MedDRA coding
Complex Regional Pain Syndrome
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Age between 18 and 75 years.
- Confirmed CRPS (type I or II) diagnosed according to the International Association of Pain (IASP) diagnostic criteria of CRPS (Budapest criteria) with adaption to research
- Disease lasting from 3-36 months
- Mean ADP score of at least 4 on a 11-point NRS scale ranging from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable during the baseline week
- Written informed consent.
Exclusion criteria 10
- Other causes of pain and/or inflammation in the same area as CRPS or other concomitant pain/inflammation that cannot be distinguished from CRPS.
- Spreading of the CRPS to other extremities according to IASP criteria for spreading of CRPS
- Initiation of new pain medication or corticosteroids.
- Poor compliance or patients who cannot cooperate or are unable to be able to complete the project and language difficulties.
- Severe depression or other significant psychiatric disease, alcohol or drug abuse.
- Pregnancy or lactation.
- Women of child-bearing potential unless they use an acceptable effective contraception measure during the study and at least 6 months after or their male partner is vasectomized and their sole partner.
- Known allergy to any component of fremanezumab.
- Planned surgery.
- Significant severe disease
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Difference between groups (placebo vs. active treatment) in the change in self-reported daily ratings of mean average daily pain intensity (ADP) in the affected limb from the baseline week to the last week of treatment, as experienced during the past 24 hours, rated on a 0–10-point numeric rating scale (NRS; 0 = no pain, 10 = worst possible pain).
Secondary endpoints 4
- Difference in Pain relief on a 6-point scale: complete, good, moderate, mild, none, worse.
- Difference in the change in mean CRPS severity score (CSS) from end of baseline to end of week 4 and 8.
- Differences in the area and intensity of mechanical allodynia, assessed by brushing a soft brush (Somedic) twice with a speed of 1-2 cm/s
- The relationship between the primary outcome measure and the duration of CRPS (measured in months).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
AJOVY 225 mg solution for injection in pre-filled syringe
PRD7211348 · Product
- Active substance
- Fremanezumab
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 225 mg milligram(s)
- Max total dose
- 225 mg milligram(s)
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Authorised
- ATC code
- N02CD03 — -
- Marketing authorisation
- EU/1/19/1358/002
- MA holder
- TEVA GMBH
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
-
V07AB · Product
- Pharmaceutical form
- PHF00017MIG
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 1 mg/ml milligram(s)/millilitre
- Max total dose
- 2 mg/ml milligram(s)/millilitre
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Authorised
- ATC code
- V07AB — SOLVENTS AND DILUTING AGENTS, INCL. IRRIGATING SOLUTIONS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Aarhus University Hospital
- Sponsor organisation
- Aarhus University Hospital
- Address
- Palle Juul-Jensens Boulevard 99
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Scientific contact point
- Organisation
- Aarhus University Hospital
- Contact name
- Sandra Sif Gylfadottir
Public contact point
- Organisation
- Aarhus University Hospital
- Contact name
- Sandra Sif Gylfadottir
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus University ORG-100028380
|
Aarhus N, Denmark | On site monitoring, Code 9 |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 60 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2023-12-11 | 2023-12-11 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2022-503167-15-00 | 3.0 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 2 |
| Subject information and informed consent form (for publication) | Dine rettigheder som forsgsperson i forsg med medicin | 1 |
| Subject information and informed consent form (for publication) | L1_Patientinformation | 3.0 |
| Subject information and informed consent form (for publication) | L2_Forsgspersoner sges | 3.1 |
| Subject information and informed consent form (for publication) | SamtykkeerklringS4-biobank | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | summary of product information | 1 |
| Synopsis of the protocol (for publication) | Synopsis of the protocol | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-24 | Denmark | Acceptable 2023-06-07
|
2023-06-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-17 | Denmark | Acceptable 2024-11-12
|
2024-12-05 |