Study on the Effectiveness and Safety of AP707 with Lamotrigine and Amitriptyline for Patients with Chronic Central Neuropathic Pain

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What is this study about?

This clinical trial is focused on evaluating the effectiveness and safety of a treatment called AP707 for individuals experiencing chronic pain due to central neuropathy. Central neuropathy is a condition where nerve damage in the central nervous system causes persistent pain. The study aims to determine how well AP707 works as an additional treatment for managing this type of pain.

Participants in the study will receive either the AP707 treatment or a placebo, which looks like the treatment but does not contain the active ingredient. The study will last for a total of 52 weeks, during which participants will be monitored at various intervals to assess changes in their pain levels and overall well-being. The treatment is administered as a sublingual spray, meaning it is sprayed under the tongue for absorption.

Throughout the study, participants’ pain levels will be measured using a simple scale, and other aspects such as quality of life, sleep quality, and psychological well-being will also be evaluated. The goal is to see if AP707 can provide significant relief from chronic pain and improve the quality of life for those affected by central neuropathy.

1 beginning of the trial

Upon joining the clinical trial, you will be introduced to the study’s objectives and procedures. You will be asked to provide a signed and dated informed consent form, confirming your understanding and willingness to participate.

You will be assessed to ensure you meet the inclusion criteria, such as having chronic pain due to central neuropathy for at least three months and a pain intensity of 5 or more on a scale from 0 to 10.

2 baseline assessment

Before starting the treatment, a baseline assessment will be conducted. This includes completing questionnaires to evaluate your current pain levels, psychological distress, and quality of life.

The Numeric Rating Scale (NRS) will be used to measure your pain intensity, and other questionnaires like the Neuropathic Pain Symptom Inventory (NPSI) and Depression Anxiety Stress Scales Short Form (DASS-21) will be administered.

3 treatment phase 1

You will begin the first treatment phase, which lasts for 14 weeks. During this time, you will receive either the active treatment, AP707, or a placebo. The treatment is administered as a sublingual spray, which means it is sprayed under the tongue.

Your pain levels and other health indicators will be monitored regularly. You will be asked to report any changes in your condition and any side effects you experience.

4 evaluation at week 14

At the end of the first treatment phase, your pain levels will be reassessed using the NRS and other questionnaires. This evaluation will help determine the effectiveness of the treatment.

You will continue to the next phase of the trial based on the results of this assessment.

5 treatment phase 2

The second treatment phase lasts until week 26. You will continue receiving the same treatment as in the first phase, either AP707 or placebo.

Regular monitoring and assessments will continue, focusing on changes in pain levels and overall health.

6 evaluation at week 26

Another evaluation will be conducted at the end of the second treatment phase. Your pain levels and other health indicators will be reassessed.

The results will be compared to previous assessments to track any improvements or changes.

7 treatment phase 3

The third and final treatment phase extends to week 52. You will continue with the same treatment regimen.

Ongoing assessments will be conducted to monitor your condition and any side effects.

8 final evaluation at week 52

At the end of the trial, a comprehensive evaluation will be conducted. This includes reassessing your pain levels, psychological distress, and quality of life.

The data collected throughout the trial will be analyzed to determine the overall efficacy and tolerability of the treatment.

Who Can Join the Study?

Signed and dated informed consent form.
Patients with chronic pain due to central neuropathy for at least 3 months. Central neuropathy refers to nerve damage in the central nervous system, which includes the brain and spinal cord.
Female and male patients who are 18 years or older.
Patients with a life expectancy of more than 1 year.
Patients with optimized sCPT at the start of the study. sCPT refers to a specific treatment plan that has been adjusted to the best possible level.
Willingness to use reliable contraception during the study and for three months after the last dose of study medication.
Good command of the German language to understand questionnaires in German.
Current moderate to severe pain with a pain intensity of 5 or more on a Numeric Rating Scale (NRS), which is a scale from 0 to 10 used to measure pain levels.
Completed QUISS questionnaire with a score of 45 or less. The QUISS is a questionnaire used to assess certain symptoms.

Who Cannot Join the Study?

Patients who have a different type of pain that is not caused by central neuropathy cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, meaning they might need special protection or care, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medical University Of Vienna	Vienna	Austria
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Universitaet Leipzig	Leipzig	Germany

Other Sites

Site Name	City	Country
Landeskrankenanstalten-Betriebsgesellschaft Kabeg	Klagenfurt am Wörthersee	Austria
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Kepler Universitaetsklinikum GmbH	Linz	Austria
Katholisches Klinikum Bochum gGmbH	Bochum	Germany
Klinikum Dortmund gGmbH	Dortmund	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Saarland University Hospital	Homburg	Germany
Universitaetsklinikum Wuerzburg AöR	Wuerzburg	Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Staedtisches Klinikum Karlsruhe gGmbH	Karlsruhe	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Oberoesterreichische Gesundheitsholding GmbH	Steyr	Austria
Klinikum Wels-Grieskirchen GmbH	Wels	Austria
Ruhr University	Bochum	Germany
Christliches Klinikum Unna gGmbH	Unna	Germany
BG Klinikum Unfallkrankenhaus Berlin gGmbH	Berlin	Germany
Hausarztzentrum Butendorf	Gladbeck	Germany
Algesiologikum MVZ GmbH	Munich	Germany
BG Klinikum Hamburg gGmbH	Hamburg	Germany
Westmecklenburg Klinikum Helene von Buelow GmbH	Hagenow	Germany
Noe LGA Gesundheit Region Mitte GmbH	Tulln An Der Donau	Austria
Medicross MVZ GmbH	Neckarsulm	Germany
Schwerpunktpraxis Fuer Schmerztherapie Berufsausübungsgemeinschaft GbR	Ulm	Germany
Schmerztherapiezentrum Brau Michel	Osnabrück	Germany
Ueberoertliche Berufsausuebungsgemeinschaft Schmerz Und Palliativzentrum Rhein Main GbR	Frankfurt	Germany
BG Klinikum Duisburg gGmbH	Duisburg	Germany
BDH-Klinik Elzach gGmbH	Elzach	Germany
Schmerzzentrum Inn-Salzach	Burghausen	Germany
Schmerzzentrum Bocholt	Bocholt	Germany
Praxis Fur Neurologie	Hoppegarten	Germany
Praxisklinik Dr. Ibrahim & Kollegen	Munich	Germany
Schmerzkompetenzzentrum	Bad Vöslau	Austria
BG Klinik Tübingen	Tuebingen	Germany
Schmerztherapiezentrum Villingen-Schwenningen	Villingen-Schwenningen	Germany
Gemeinschaftspraxis Michael Jokiel und Andreas Lütgen	Borken	Germany
Schmerzzentrum Geldern	Geldern	Germany
Ummxkopgxrzvlstxggvdz Ggacgmp uam Mxjtxfl Gsrv	Marburg	Germany
Kfpspl Ocudhskv	Oberwart	Austria
Zkystru fhi Syyzshuc uht Ptsqlbezcyekjwhz Szyfbitl	Schwerte	Germany
Mwxahp Hqynaqbv Hhqsp Ucffvnvwgfzgwiunarpm dss Rflslmqzraavkvmh Buzgvj	Herne	Germany
Uofylgadxjcjabgsnebsd Ewdwq Ayw	Essen	Germany
Bivnbgigkftpxmripkgnvilnuf Udjvmmmysfpgqwhwttbdo Bqfbvgsdhjwdn gkrpw	Bochum	Germany
Usxvstvfnmcnvvfllnpzk Arbzbnan	Augsburg	Germany
Gcyugk Uyiprcpvtp Fubxdygla	Frankfurt	Germany

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	01.05.2023
Germany	Not recruiting	01.05.2023

Trial locations

Investigated drugs:

AP707 is a medication being tested to see how well it works and how well people can tolerate it when used as an additional treatment for chronic pain. This type of pain is caused by damage to the central nervous system, which includes the brain and spinal cord. The goal of using AP707 in this trial is to help reduce the pain that patients experience due to this kind of nerve damage. The trial is focused on understanding if AP707 can effectively help manage this pain and improve the quality of life for patients who suffer from it.

Investigated diseases:

Central Neuropathic Pain – Central neuropathic pain is a type of chronic pain that arises from damage or dysfunction in the central nervous system, which includes the brain and spinal cord. This condition can result from various causes, such as stroke, multiple sclerosis, or spinal cord injury. The pain is often described as burning, shooting, or stabbing and can be persistent or intermittent. It may be accompanied by other symptoms like tingling, numbness, or a sensation of pins and needles. Over time, the pain can become more intense and may spread to other areas of the body. The progression of central neuropathic pain can vary greatly among individuals, depending on the underlying cause and the extent of nerve damage.

Trial ID:

2022-500899-66-00

Protocol code:

DISCOVER_(ZNP)

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of AP707 with Lamotrigine and Amitriptyline for Patients with Chronic Central Neuropathic Pain

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?