Study on the Effectiveness and Safety of AP707, Amitriptyline, and Capsaicin for Patients with Chronic Pain from Diabetic Neuropathy

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What is this study about?

This clinical trial is focused on studying the effectiveness and safety of a treatment called AP707 for individuals experiencing chronic pain due to diabetic polyneuropathy. Diabetic polyneuropathy is a condition that affects the nerves, often leading to persistent pain. The trial aims to evaluate 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 be conducted over several weeks, with regular assessments to monitor changes in pain levels and overall well-being. The goal is to determine if AP707 can provide significant relief from pain compared to the placebo.

Throughout the trial, participants will be asked to report their pain levels and any changes in their condition. The study will also track any side effects or adverse events to ensure the safety of the treatment. By the end of the study, researchers hope to gather valuable information about the potential benefits of AP707 for those suffering from chronic pain due to diabetic polyneuropathy.

1 beginning of the trial

Upon joining the study, you will be asked to provide a signed and dated informed consent form. This confirms your understanding and agreement to participate in the trial.

You will undergo an initial assessment to confirm eligibility, which includes verifying that you have experienced chronic pain due to diabetic polyneuropathy for at least three months and that your pain intensity is moderate to severe.

2 baseline assessment

A baseline assessment will be conducted to establish your current pain levels and overall health status. This includes completing questionnaires such as the Numeric Rating Scale (NRS) for pain and the Neuropathic Pain Symptom Inventory (NPSI).

You will also be asked to complete additional questionnaires to assess psychological distress, quality of life, and sleep quality.

3 treatment phase 1

You will begin the first treatment phase, which lasts for 14 weeks. During this time, you will receive either the study medication AP707 or a placebo. The medication 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 through scheduled visits and questionnaires.

4 evaluation at week 14

At the end of week 14, your pain levels will be reassessed using the Numeric Rating Scale (NRS) and other questionnaires. This evaluation will help determine the effectiveness of the treatment during the first phase.

You will continue to receive either the study medication or placebo as the trial progresses into the next phase.

5 treatment phase 2

The second treatment phase extends from week 15 to week 26. You will continue with the same treatment regimen as in the first phase.

Regular assessments will be conducted to monitor any changes in your pain levels and overall health.

6 evaluation at week 26

At the end of week 26, another evaluation will be conducted to assess changes in your pain levels and other health indicators.

This evaluation will help determine the effectiveness of the treatment during the second phase.

7 treatment phase 3

The third and final treatment phase lasts from week 27 to week 52. You will continue with the same treatment regimen.

Your health and pain levels will be monitored regularly through scheduled visits and questionnaires.

8 final evaluation at week 52

At the end of week 52, a final evaluation will be conducted to assess the overall effectiveness of the treatment throughout the trial.

This includes a comprehensive assessment of your pain levels, quality of life, psychological distress, and sleep quality.

Who Can Join the Study?

Signed and dated informed consent form.
Patients with chronic pain due to diabetic polyneuropathy for at least 3 months. Diabetic polyneuropathy is a type of nerve damage that can occur with diabetes, causing pain.
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 is adjusted for the patient.
Willingness of both male and female patients to use reliable contraception during the study and for three months after taking the last 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 the Numeric Rating Scale (NRS), which is a scale from 0 to 10 used to measure pain, indicating a need for further pain therapy.
Completed QUISS (Quantification Inventory for Somatoform Syndromes) questionnaire with a score of 45 or less. This questionnaire helps assess certain symptoms related to pain.

Who Cannot Join the Study?

Patients who do not have chronic pain due to diabetic polyneuropathy cannot participate. This means the study is only for those who have long-lasting pain caused by nerve damage from diabetes.
Patients who are not within the specified age range cannot participate. The study is for adults only.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care are not included.

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
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH	Villingen-Schwenningen	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
Schmerzzentrum Inn-Salzach	Burghausen	Germany
Schmerzzentrum Bocholt	Bocholt	Germany
Praxis Fur Neurologie	Hoppegarten	Germany
Praxisklinik Dr. Ibrahim & Kollegen	Munich	Germany
BG Klinik Tübingen	Tuebingen	Germany
Urwjbvsmlnbklmuscgjml Gkjqbep upi Mqpcgfx Guss	Marburg	Germany
Kzdygo Owuxcbml	Oberwart	Austria
Zwqlnyv fkx Sakjgelb ucd Pevnhsryxsxubdkc Shcutqgp	Schwerte	Germany
Gtixxtljyolipvffzhk Mvcmzyj Jgahye uvs Atmrapv Litnak	Borken	Germany
Mpxpes Hqdleayx Hfjuo Utdluhladjvcglpnzaox dfu Rekgujckxuuoxzoj Baotev	Herne	Germany
Grbkxe Ugylwatalc Famhjxnut	Frankfurt	Germany
Uacbwagyatmhomaxiyuzb Ewepk Ayd	Essen	Germany
Bxtkpaawzuarrwqviobjsmevaz Urmfsyvedtjzovhiyglvo Bdvheapksbpmg gzfkr	Bochum	Germany
Uugojkpolevariqfsnwvr Azjgzxjt	Augsburg	Germany
Srsrfgueszjmkaelmayqurm	Bad Vöslau	Austria
Szzojpjsxvcsgo Ggysfno	Geldern	Germany

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	01.09.2023
Germany	Not recruiting	01.09.2023

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 caused by diabetic polyneuropathy. Diabetic polyneuropathy is a condition where people with diabetes experience nerve damage, leading to pain, tingling, or numbness, usually in the feet and hands. AP707 is being studied to determine if it can help reduce this type of pain when added to the patient’s current treatment plan.

Investigated diseases:

Diabetic Polyneuropathy – Diabetic polyneuropathy is a type of nerve damage that occurs in individuals with diabetes. It primarily affects the peripheral nerves, which are responsible for sensation and movement in the limbs. The disease progresses gradually, often starting with numbness or tingling in the feet and hands. Over time, it can lead to more severe symptoms such as burning pain, muscle weakness, and loss of reflexes. As the condition advances, it may affect balance and coordination, making walking difficult. The progression of symptoms can vary widely among individuals, depending on factors like blood sugar control and duration of diabetes.

Trial ID:

2022-500897-32-00

Protocol code:

DISCOVER_(PNP1)

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of AP707, Amitriptyline, and Capsaicin for Patients with Chronic Pain from Diabetic Neuropathy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?